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Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

19 Study Matches

Return to Work Survey Development for Breast Cancer Survivors

The purpose of this study is to develop and test a survey to gain information that will improve our understanding of the return to work experience for breast cancer survivors. Study participants will answer questions on a questionnaire and undergo a one-on-one interview about those questions to ensure the wording and content is appropriate.

This is a questionnaire development study. Participants will be asked to complete a series of questions on a questionnaire form. Next, participants will sit for a one-on-one interview to discuss the questions and answer choices on the questionnaire.

Yes
 

Meghan Vidt
Jared Heitzenrater - at jheitzenrater@pennstatehealth.psu.edu or 717-531-0003, ext=323324
Biomedical Engineering (UNIVERSITY PARK)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00019881
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Inclusion Criteria:
Previous diagnosis of breast cancer, stage 0-III
Last cancer treatment was 2-5 years ago
Received breast cancer treatment at Penn State Health
Employed outside the home at least part time (>20hr/wk) before and after cancer treatment

Exclusion Criteria:
Last cancer treatment was less than 2 years or greater than 5 years ago
Underwent prophylactic treatment due to increased risk, such as testing positive for BRCA gene (breast cancer)
Unemployed or does not participate in the workforce for pay either before or after cancer
Currently being treated for any type of cancer
Has experienced a work-related injury that does not allow work, is receiving Worker's Compensation, or is currently in litigation for work-related injury
Cancer
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Hershey, PA ,

PSCI 22-156 HCRN BRE17-141

The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.

Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987203
SITE00001343
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Inclusion Criteria:
Anatomic, clinical stage I-III, invasive breast cancer, greater than 10mm.
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.

Exclusion Criteria:
Locally advanced or inflammatory breast cancer.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

A011801 THE COMPASSHER2 TRIALS (COMPREHENSIVE USE OF PATHOLOGIC RESPONSE ASSESSMENT TO OPTIMIZE THERAPY IN HER2-POSITIVE BREAST CANCER): COMPASSHER2 RESIDUAL DISEASE (RD), A DOUBLE-BLINDED, PHASE III RANDOMIZED TRIAL OF T-DM1 AND PLACEBO COMPARED WITH T-DM1 AND TUCATINIB (PSCI# 21-155)

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning

The purpose of this study is to compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib. The addition of tucatinib to the usual treatment could prevent the breast cancer from returning.

Yes
 

Cristina Truica
psci-cto@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04457596
SITE00001048
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Inclusion Criteria:
Age = 18 years or older (male or female)
ECOG Performance Status 0-1
Patients must have received neoadjuvant chemotherapy with one of the following regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P).
HER2-positive breast cancer per pathology
Prior treatment must have consisted = 6 cycles of chemotherapy and HER2-directed therapy, with a total duration of = 12 weeks, including at least 9 weeks of preoperative taxane and trastuzumab with or without pertuzumab (or FDA-approved biosimilars).

Exclusion Criteria:
Prior receipt of T-DM1 in the neoadjuvant setting is not allowed.
Patients with known active and/or untreated Hepatitis B or Hepatitis C or chronic liver disease are ineligible.
Stage IV (metastatic) breast cancer
History of any prior (ipsi- or contralateral) invasive breast cancer within 3 years of registration
Patients with ER+ HER2+ residual invasive disease that is lymph node-negative per the surgical pathology report
Cancer
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Hershey, PA ,

A Phase III De-escalation of Breast Radiation for Stage I, Hormone Sensitive, HER2 Negative Breast Cancer (PSCI# 21-098) (NRG-BR007)

This study is being done to answer the following question:Is treatment with hormonal therapy as good as the usual treatment of radiation and hormonal therapy in women with low-risk breast cancer who have had lumpectomy? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your breast cancer. The usual approach is defined as care most people get for low-risk, early stage breast cancer that is sensitive to hormones.

Pt will either have radiation therapy to the breast and take a hormonal drug for at least five years or you will only take a hormonal drug for at least five years.

Yes
 

Leonard Tuanquin
psci-cto@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04852887
SITE00001018
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Inclusion Criteria:
The patient must be > 50 years and < 70 years of age
The patient must have recovered from surgery with the incision completely healed and no signs of infection
The patient must have an ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease
pT2 - pT4 tumors including inflammatory breast cancer
Patient had a mastectomy
Non-epithelial breast malignancies such as sarcoma or lymphoma
Paget's disease of the nipple
Cancer
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Hershey, PA ,

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136)

The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.

pt will initially get the chemotherapy drug paclitaxel or docetaxel along with trastuzumab, pertuzumab, and either placebo or atezolizumab.

Yes
 

Monali Vasekar
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03199885
SITE00000916
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Inclusion Criteria:
Patient must have an ECOG Performance Status of 0 or 1
Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease
Adequate hematologic function within 14 days prior to randomization
Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization
Adequate renal function determined within 14 days prior to randomization

Exclusion Criteria:
Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded
History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent
Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Cancer
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Hershey, PA ,

Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study

Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.

Attend 4 in person visits, blood will be drawn at each visit.Complete physical function tests and surveys.Wear accelerometer for 7 days following each visit.Randomly selected participants will attend group exercise sessions twice a week for eight weeks via video call and record exercise activities between visits.

$160

Yes
 

Nancy Olsen
Nancy Olsen - at nolsen@pennstatehealth.psu.edu
Medicine: Rheumatology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03955627
STUDY00010776
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Inclusion Criteria:
Age 60 and older
Female
Breast Cancer Survivor
Preparing to Start AI medication
ER+ diagnosis

Exclusion Criteria:
Already taking AI medication (greater than 24 weeks)
Gross Cognitive Impairment
Recent Joint Surgery
Cardiac event/Stroke within last 6 months
Not willing to come to HMC for Exercise Sessions
Cancer
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Hershey, PA ,

TMIST_EA1151

This study is being done to answer the following question:Can tomosynthesis mammography, three-dimensional x-ray imaging of the breast, lower your chance of developing life-threatening breast cancer through routine screening compared with digital mammography, two-dimensional x-ray imaging of the breast?We are doing this study because we want to find out which of the two usual approaches to breast cancer screening are better in the early detection of life-threatening breast cancers.

Yes
 

Rebecca Sivarajah
Swati Shah - at sshah@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

Female
18 year(s) or older
This study is also accepting healthy volunteers
NCT03233191
SITE00000587
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Inclusion Criteria:
Women age 45 or older and under age 75 at the time of study entry
Patients must be scheduled for, or have intent to schedule, a screening mammogram.
Patients must be able to tolerate digital breast tomosynthesis and fullfield digital mammographic imaging required by protocol.
Patients must be willing and able to provide a written informed consent.

Exclusion Criteria:
Women of childbearing potential must not be known to be pregnant or lactating.
Patients must not have new symptoms or signs of benign or malignant breast disease
Patients must not have had a screening mammogram within the last 11 months prior to date of randomization.
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Patients must not currently have breast enhancements (e.g., implants or injections).
Prevention, Cancer, Women's Health
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Hershey, PA ,

CCTG MA.39- A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

Purpose of this study is to compare any good and bad effects of not using regional radiotherapy to using radiotherapy. The study will help researcher learn if not giving regional radiotherapy is just as good as using regional therapy to treat node positive breast cancer in women.

Blood will be drawn at two time points and number of visits will be determined by the individual radiation treatment plan.

Yes
 

Marc Rovito
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
Cancer Institute (ST. JOSEPH)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
AFFILCCTGMA39
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Inclusion Criteria:
Estrogen Receptor Positive / Her2 Negative Breast Cancer
No evidence of metastasis
1 - 3 positive lymph nodes
May have had breast conserving surgery or mastectomy
35 years of age or older

Exclusion Criteria:
Nodal disease limited to micromets or isolated cells
History of ipsilateral breast cancer or DCIS
Synchronous or contralateral breast cancer
pT4 disease
Neoadjuvant Chemotherapy for breast cancer
Cancer
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Reading, PA ,

A PHASE III, RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF ADJUVANT GIREDESTRANT COMPARED WITH PHYSICIAN'S CHOICE OF ADJUVANT ENDOCRINE MONOTHERAPY IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE EARLY BREAST CANCER (PSCI# 20-133) (GO42784)

The purpose of this study is to compare the effects, good or bad, of giredestrant versus an approved endocrine therapy (a treatment that blocks or removes hormones), on patients with breast cancer. In this study, subjects will get either giredestrant or a drug chosen specifically by the study doctor. Subjects can participate in this study based on breast cancer characteristics, current condition, and how well previous anti-cancer therapies were tolerated.

• You should not join another research study.• For women: If you can become pregnant, you must use a reliable non-hormonal birth control method during the study and for 9 days after your final dose of giredestrant or, if you are in the group receiving approved endocrine therapy prescribed by the study doctor, a period of time that your study doctor will discuss with you. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 60 days after if you are prescribed tamoxifen. Talk with your study doctor about what birth control method may be best for you. Depending on the study treatment you receive, you might be restricted from donating eggs during this same period. Tell your study doctor right away if you get pregnant during this period. If you get pregnant, the study doctor will want to follow up with you on the outcome of the pregnancy and collect information on the baby.• For men: you must agree to take precautions as outlined below for each treatment arm:–If you are in the group receiving approved endocrine therapy prescribed by the study doctor, you study doctor will discuss with you what precautions you will need to take.–If you are in the group receiving giredestrant, and your partner is pregnant or able to become pregnant, you must use a condom during the study and for 9 days after your final dose of giredestrant. This will be 21 days after if you are prescribed letrozole or anastrozole, 30 days after if you are prescribed exemestane, and 90 days after if you are prescribed tamoxifen. You must not donate sperm during this same period. Tell your study doctor right away if your partner becomes pregnant during these periods. The study doctor or research staff will advise you of the possible risks to your unborn child and will make an effort to contact your partner to get her permission to collect information about the pregnancy and the baby. No matter what your partner decides, you can continue to take part in this study.• You should not use certain medications during this study. Your study doctor will talk to you about these medications.

Yes
 

Monali Vasekar
Kelly Hansard - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5317
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04961996
STUDY00019397
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Inclusion Criteria:
Participants (females, regardless of menopausal status, and males) who are age  18 years at the time of signing the Informed Consent Form
Participants who have documented ER+ tumor by immunohistochemistry, as assessed locally on a primary disease specimen and defined as  1% of tumor cells stained positive according to the ASCO/College of American Pathologists (CAP) guidelines
Participants who have documented HER2- tumor, as assessed locally on a primary disease specimen and defined according to ASCO/CAP guidelines
Participants must have undergone definitive surgery of the primary breast tumor(s)
Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization

Exclusion Criteria:
Participants who are pregnant or breastfeeding, or intending to become pregnant during the study or within 9 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of TPC
Participants who have received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research
Participants receiving or planning to receive a CDK4/6i as adjuvant therapy
Participants who have active cardiac disease or history of cardiac dysfunction
Participants who have been diagnosed with Stage IV breast cancer
Cancer
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Hershey, PA ,

20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04266249
SITE00000861
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Inclusion Criteria:
Histologically confirmed HER2-positive primary invasive breast carcinoma
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).

Exclusion Criteria:
Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer.
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
Cancer
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Hershey, PA ,

Phase II Trial of Palbociclib with Fulvestrant in Individuals withHormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer who have Progressed on Treatment with Palbociclib and an Aromatase Inhibitor

In this phase II trial, we will determine the progression-free survival (PFS) of the cyclin dependent kinase 4/6 inhibitor (CDK4/6i) palbociclib with fulvestrant in women and men with estrogen or progesterone receptor (ER/PR) positive, HER2-negative metastatic breast cancer (MBC) who progressed on treatment with palbociclib and an aromatase inhibitor (AI). We will also determine the prevalence rate of estrogen eceptor α (ESR1) and phosphatidylinositol-3-kinase (PI3K) mutations in the study population.

Participants will be required to come to the clinic every three weeks for evaluation and fulvestrant injections, take medication correctly, keep all appointments.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02738866
STUDY00010878
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Inclusion Criteria:
Men and women, 18 years of age or older
Histologically or cytologically confirmed adenocarcinoma of the breast with evidence of metastatic disease (stage IV) or locally advanced disease,
ER-positive and/or PR-positive tumor (≥1% positive stained cells) • HER2-negative tumor
Progressed on and following at least 6 months of combined treatment with palbociclib and AI therapy for advanced/metastatic breast cancer, and be able and willing to receive additional palbociclib treatment
Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion Criteria:
Women who are pregnant or breast-feeding
Concurrent use of any of the following medications during study participation: • Inhibitors or inducers of CYP3A4 that may affect serum concentrations of palbociclib
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 2 weeks before registration.
Any other malignancy within 3 years prior to registration, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix.
Prior hematopoietic stem cell or bone marrow transplantation.
Cancer
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Hershey, PA ,

PSCI 22-127 NRG-BN012: A RANDOMIZED PHASE III TRIAL OF PRE-OPERATIVE COMPARED TO POST-OPERATIVE STEREOTACTIC RADIOSURGERY IN PATIENTS WITH RESECTABLE BRAIN METASTASES

Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.

Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.

Yes
 

Sean Mahase
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05438212
SITE00001293
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Inclusion Criteria:
Radiographic confirmation of 1-4 brain metastases, one of which requires resection, as defined by MRI with contrast obtained within 14 days prior to registration
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18

Exclusion Criteria:
Prior cranial radiotherapy,
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
Cancer
Not applicable
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Hershey, PA ,

PSCI 22-141 CCTG MA.39: “Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive and T3N0 Breast Cancer

To compare the breast cancer recurrence-free interval (BCRFI) between patients that received regional RT or not, defined as time from randomization to time of invasive recurrent disease in the ipsilateral chestwall, breast, regional nodes, distant sites or death due to BC.

Women with low risk breast cancer will be randomized to either regional radiation therapy or no regional breast radiation therapy. Patients will be expected to keep all of their radiation appointment and complete all questionnaires.

Yes
 

Leonard Tuanquin
PSCI CTO at PSCI-CTO@pennstatehealth.psu.edu
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03488693
SITE00001308
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Inclusion Criteria:
Patients must be women with newly diagnosed histologically proven invasive carcinoma of the breast with no evidence of metastases, staged as per site standard of care
Patients must have been treated by BCS or mastectomy with clear margins of excision*.
Patients with T3N0 disease are eligible.
Patients with disease limited to nodal micrometastases are eligible.
Patients must be ER ≥ 1% and HER2 negative on local testing

Exclusion Criteria:
Patients with nodal disease limited to isolated tumour cells
Patients with pT3N1 and pT4 disease
Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy
Synchronous or previous contralateral invasive breast cancer.
Patients who are pregnant.
Cancer
Not applicable
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Hershey, PA ,

Prospective Evaluation of Carvedilol in Prevention of Cardiac Toxicity in Patients with Metastatic HER-2+ Breast Cancer, Phase III (PSCI# 20-135) (S1501)

The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.

The purpose of this study is to test whether carvedilol can reduce the occurrence of heart problems during your cancer treatment. Carvedilol (Coreg®) is a medication that is FDA approved and used to treat congestive heart failure and high blood pressure and is not a new medication. It has been shown in small studies to protect the heart from side effects of chemotherapies such as doxorubicin (Adriamycin®) and trastuzumab (Herceptin®). The effects of carvedilol will be compared to the usual approach. Previously, people who were already taking a beta blocker, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitor were able to take part in the study. The study has reached the maximum number of people allowed who are already on those treatments now, so, you must not be taking these types of drugs in order to be part of the study. There will be about 817 people taking part in this study.

Yes
 

Monali Vasekar
psci-cto@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03418961
SITE00001123
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Inclusion Criteria:
Patients must have a Zubrod Performance Status of 0-2.
Patients must be ≥ 18 years of age.
Patients must have a complete physical examination and medical history within 28 days prior to registration.
Patients must not be dialysis dependent
Patients must be able to swallow tablets.

Exclusion Criteria:
Patients are dialysis dependent.
Patients have uncontrolled asthma.
Patients who are pregnant or nursing
Patients who are unable to swallow tablets.
Patients who do not have adequate hepatic function
Cancer
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Hershey, PA ,

A Phase II Study of Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

Participants in this study will receive a drug called ribociclib with the endocrine therapy of your physician’s choice. Ribociclib is taken as a pill. Endocrine therapy is taken as a pill or given as a shot. You will have tests, exams and procedures that are part of your regular care and for study purposes. Also, as part of routine care, you will be checked every 4 to 12 weeks to make sure your cancer hasn’t come back. You will receive ribociclib combined with endocrine therapy for up to 3 years. After that you will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care.

Participants will be required to: - receive ribociclib along with standard endocrine therapy drugs - have blood drawn - imaging scans (CT, PET-CT, bone scans, mammograms, MRI) - keep a medication diary - optional biopsy - ECG-a test that looks at the way your heart beats - ECHO-a test that looks at the way your heart pumps

Yes
 

Monali Vasekar
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05467891
STUDY00022070
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Inclusion Criteria:
Written informed consent and HIPAA authorization for release of personal health information obtained prior to performing any study-specific screening procedures.
Male or female age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
If patient is receiving tamoxifen or toremifene, a washout period of 28 days prior to registration is required.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.

Exclusion Criteria:
Patient with a known hypersensitivity to any of the excipients of ribociclib.
Patient who has received prior CDK4/6 inhibitor for recurrent disease. Patients who received a CDK4/6 inhibitor in the adjuvant setting may participate if they have been off therapy for at least 1 year prior to diagnosis of recurrent disease.
Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
Pregnant or breastfeeding or planning to become pregnant during the trial
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

PSCI 22-142 A Randomized, Open-label, Phase 3 Study of Sacituzumab GovitecanVersus Treatment of Physician’s Choice in Patients With HormoneReceptor-Positive (HR+)/Human Epidermal Growth Factor Receptor2 Negative (HER2−) (HER2 IHC0 or HER2-low [IHC 1+, IHC2+/ISH−]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

This trial is to compare the effects of sacituzumab govitecan versus physician's choice in the treatment of breast cancer

Potential participants will be expected to come to all study visits, complete questionnaires, take the medication as prescribed by the study doctor, report any changes in medications of symptoms while on the trial.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05840211
STUDY00023127
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Inclusion Criteria:
Assigned male or female at birth, 18 years of age or older (or minimum age according to country-specific requirements), able to understand and give written informed consent.
Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site, either in a formalin-fixed, paraffin-embedded block or newly sectioned, unstained slides for HER2 status and other biomarker assessments.
Documented evidence of HR+ metastatic breast cancer (mBC)
Documented evidence of HER2− status
Documented PD by computed tomography (CT) or magnetic resonance imaging

Exclusion Criteria:
Progressive disease within 6 months of completing (neo)adjuvant chemotherapy.
Previously HER2+
Locally advanced mBC (Stage IIIc) in patients who are candidates for curative intent therapy at the time of study enrollment
Current enrollment in another clinical study
Treatment with definitive radiation within 2 weeks prior to the first dose of study drug
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Patient and Provider Preferences for Breast Cancer Treatment Side Effect Prediction

This one-time survey seeks to understand both patient and provider perspectives of and preferences for a predictive test for side effects among breast cancer patients treated with an aromatase inhibitor (AI).

Complete a one-time electronic survey asking for opinions on a predictive test for side effects of aromatase inhibitor (AI) breast cancer treatments.

No
 

Cheryl Thompson
Cheryl Thompson - at cthompson11@pennstatehealth.psu.edu
Public Health Sciences (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00024191
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Inclusion Criteria:
Female aged 21 and older
New diagnosis of non-metastatic breast cancer (stage 0-III) at Penn State Health within the last 5 years
Prescribed at least one AI as part of breast cancer treatment at least one year ago

Exclusion Criteria:
Under age 21 years old
Inability to provide consent in English or Spanish
Cancer
Survey(s)
I'm interested
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PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY

this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.

Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.

Yes
 

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05812807
STUDY00024629
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Inclusion Criteria:
Age ≥ 18 years
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.

Exclusion Criteria:
No stage IV (metastatic) breast cancer
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
Cancer
Approved drug(s)
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Hershey, PA ,

PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)

This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.

Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.

Yes
 

Leonard Tuanquin
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Radiology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05705401
STUDY00024714
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Inclusion Criteria:
The patient must be ≥ 40 years of age.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.

Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)
Cancer
Experimental drug compared to an approved drug
I'm interested
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Study Locations

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Location Contacts
Hershey, PA ,