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18 Study Matches

Phase II Trial of Palbociclib with Fulvestrant in Individuals with Hormone 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.

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

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 ,

Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Big Ten Cancer Research Consortium BTCRC-BRE19-409

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination with Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

We are asking you to take part in this voluntary research study because you have breast cancer that is estrogen and progesterone receptor positive and is HER2 receptor negative. Your breast cancer also spread outside your breast (metastatic) to other areas of your body. We are asking you to take part in this research study because your cancer has a genetic mutation in a pathway called PI3K and your tumor progressed while you were receiving hormone therapy.

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04762979
STUDY00017417
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Inclusion Criteria:
Men and postmenopausal female patients. Premenopausal patients (age 18 or older) who have been rendered postmenopausal will also be included.
Confirmed metastatic or unresectable breast cancer.
Has confirmed HER2 negative breast cancer.

Exclusion Criteria:
Patients with prior chemotherapy for metastatic or advanced disease
Treatment with any investigational drug within 14 days prior to registration.
Currently documented clinically active pneumonitis.
History of acute pancreatitis within 1 year of screening
Cancer
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Hershey, PA ,

Site for 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) (A011801)

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.

Cristina Truica
psci-cto@pennstatehealth.psu.edu 717-531-5471
 

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 ,

Site for NRG-BR007: A PHASE III CLINICAL TRIAL EVALUATING DE-ESCALATION OF BREAST RADIATION FOR CONSERVATIVE TREATMENT OF STAGE I, HORMONE SENSITIVE, HER2-NEGATIVE, ONCOTYPE RECURRENCE SCORE < or = 18 BREAST CANCER (PSCI# 21-098)

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.

Leonard Tuanquin
psci-cto@pennstatehealth.psu.edu 717-531-5471
 

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 ,

Site for 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.

Monali Vasekar
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

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

Nancy Olsen
Nancy Olsen - at nolsen@pennstatehealth.psu.edu
 

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 ,

Site for Tomosynthesis Mammographic Imaging Screening Trial (TMIST)_EA1151_PSCI 19-080

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.

Rebecca Sivarajah
Swati Shah - at sshah@pennstatehealth.psu.edu
 

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.

Marc Rovito
Michelle Eschbach - at meschbach@pennstatehealth.psu.edu or 610-378-2336
 

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 ,

Site for A RANDOMIZED PHASE III DOUBLE BLINDED PLACEBO CONTROLLED TRIAL OF ASPIRIN AS ADJUVANT THERAPY FOR HER2 NEGATIVE BREAST CANCER: THE ABC TRIAL.

This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.

This is a drug study with a primary outcome of testing aspirin as therapy versus a placebo pill for patients for breast cancer.

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02927249
SITE00000491
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Inclusion Criteria:
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence.
Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed.
Age > 18 and < 70 years of age.
ECOG performance status 0-2.
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.

Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention.
No history of any prior stroke (hemorrhagic or ischemic).
No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors.
No history of atrial fibrillation or myocardial infarction.
No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Cancer
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Hershey, PA ,

Site for 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.

Monali Vasekar
psci-cto@pennstatehealth.psu.edu 717-531-5471
 

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 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.

Monali Vasekar
Kelly Hansard - at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5317
 

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 ,

Women In Steady Exercise Research - Window of Opportunity for Exercise and Tumor Biology

The aim of the study is to test how an increase in the heart rate can interact with cancer. The study population is newly diagnosed breast cancer patients. The study intervention is an acute exercise test. The primary outcome of the study is imaging of the tumor before, and in a time course after, the acute exercise test.

The study is one single visit that lasts for about 3 hours. We will ask participants to fill out a few short questionnaires. Participants will be asked to walk or jog on a treadmill for as long as they can. We will collect blood samples via an IV line 1) before the acute exercise, 2) immediately after the exercise, 3) 30 min after the exercise, and 4) 2 hours after the exercise. Also, we will use an ultrasound machine to image breast and tumor 1) before the acute exercise, 2) immediately after the exercise, 3) 30 min after the exercise, and 4) 2 hours after the exercise.

100

Kathleen Sturgeon
Kathleen Sturgeon - at kms99@psu.edu
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05428709
STUDY00019979
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Inclusion Criteria:
Newly diagnosed breast cancer patients
Breast tumor is more than 2 cm (T2)
No initiation of chemotherapy treatment
Pre-surgical breast resection
With or without lymph node involvement (N0-3)

Exclusion Criteria:
Current use of blood-thinners
Body weight <100 lbs
Started chemotherapy for breast cancer
Absolute contraindications for exercise stress testing by self-report, such as acute myocarditis or pericarditis, uncontrolled heart failure
Pregnant women
Cancer
Not applicable
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Hershey, PA ,

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

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.

Cristina Truica
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
 

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.
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Hershey, PA ,

A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium (BTCRC-BRE15-016) (16-053)

Primary Objective The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease). Secondary Objectives - Characterize safety and tolerability of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease. - Evaluate progression-free survival (PFS) per local assessment and RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Evaluate clinical benefit rate RR (complete, partial response, or stable disease, lasting 24 weeks or longer) based on RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Measure overall survival (OS) at 2 years in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen.

Cristina Truica
Lea May - at lmay1@pennstatehealth.psu.edu or 717-531-0003, ext=285550
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02668666
STUDY00005147
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Inclusion Criteria:
Locally advanced, locoregionally recurrent, or metastatic disease, not amenable to curative therapy
Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER>1%, PR>1%), Her2 negative breast cancer
No prior systemic anti-cancer therapy for advanced HR+ positive disease
Metastatic disease evaluable on imaging studies.
Adequate blood, liver and kidney function

Exclusion Criteria:
Prior treatment with any CDK 4/6 inhibitor
Confirmed diagnosis of HER2 positive disease
Known uncontrolled or symptomatic CNS metastases.
Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
Prior history of blood clots, pulmonary embolism or deep vein thrombosis.
Cancer
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Hershey, PA ,

CUFF Study: Characterization of Upper Limb Function following Mastectomy and Reconstruction for Breast Cancer

This is an observational study that will provide information describing the relationships between type of breast reconstruction and shoulder/upper extremity function and perceived health-related quality of life (HRQOL) for breast cancer survivors. This study will obtain measurements of arm strength and mobility and use self-report questionnaires to evaluate patient quality of life and satisfaction with treatment. Outcomes across three patient groups will be compared, including patients who undergo 1) lumpectomy, or mastectomy with either: 2) reconstruction with implants, or 3) reconstruction with autologous flaps.

There will be three study visits, including one visit before surgery and two visits after surgery. Before and after surgery, your strength and mobility will be measured and you will complete questionnaires. Also after surgery, there will be a one-on-one interview.

Meghan Vidt
Meghan Vidt - at mzv130@psu.edu or 814-865-6885
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00010885
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Inclusion Criteria:
Women aged 18-79 years old
Plan to undergo mastectomy as a part of breast cancer treatment
Mastectomy with or without secondary reconstruction

Exclusion Criteria:
Men
Women who do not plan to have mastectomy as a part of their breast cancer treatment
History of a stroke or neuromuscular disorder (e.g. Parkinson's disease, tremor)
Severe arthritis that affects how you move
Any condition that affects memory (e.g. Alzheimer's disease, dementia)
Cancer
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Hershey, PA ,

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.

Meghan Vidt
Jared Heitzenrater - at jheitzenrater@pennstatehealth.psu.edu or 717-531-0003, ext=323324
 

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 ,

Pivotal study of the LUM Imaging System for assisting intraoperative detection of residual cancer in the tumor bed of female subjects with breast cancer.

The objective of this prospective, multi-center, single-arm study is to demonstrate the safety and efficacy of the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM Imaging Device and decision software), in identifying residual cancer in the lumpectomy bed of female breast cancer patients in order to assist surgeons in reducing the rates of positive margins.

Daleela Dodge
Margaret Yoder - at myoder6@pennstatehealth.psu.edu or 717-531-0003, ext=286789
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03686215
STUDY00010975
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Inclusion Criteria:
Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of breast cancer, as per the exclusion criteria listed below.

Exclusion Criteria:
Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer.
Subjects who are sexually active and not willing/able to use 2 medically acceptable forms of contraception (hormonal, barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
Cancer
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See this study on ClinicalTrials.gov
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Hershey, PA ,

Women In Steady Exercise Research - Neoadjuvant Exercise Trial

The primary purpose of this pilot study is to determine whether breast cancer patients whom elect to undergo cardiotoxic neoadjuvant chemotherapy can be enrolled and retained in a 6 month at home aerobic exercise training study. Using a randomized controlled trial approach, we will examine the safety and efficacy of a well monitored moderate-to-high intensity aerobic training program completed at home in breast cancer patients receiving neoadjuvant chemotherapy. In addition to assessing safety and efficacy of the program, we will assess intervention effects on cardiopulmonary fitness, cardiac function, and tumor response.

Kathleen Sturgeon
Kathleen Sturgeon - at kms99@psu.edu or 717-531-0003, ext=284676
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
STUDY00005517
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Inclusion Criteria:
Stage 1-3 breast cancer
Scheduled to start neoadjuvant chemotherapy
Sedentary
No heart disease

Exclusion Criteria:
Stage 4 breast cancer
Heart disease
Non-English speaking
Cancer
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Greater Philadelphia Area, PA ,
Harrisburg, PA ,
Hershey, PA ,