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PSCI 23-099 NRG-BR009: A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancerand an Oncotype Recurrence Score ≤ 25 (OFSET)
To determine if chemotherapy added to ovarian suppression and endocrine therapy is better than endocrine therapy and ovarian supression alone.
Subjects will be required to keep all study appointments, take the medications as required, have an annual mammogram, inform the study of any over the counter medications they may be taking.
Patients must be premenopausal
The patient must have an ECOG performance status of ≤ 2
Patients may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.
pT4 tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer.
Life expectancy of < 10 years due to co-morbid conditions in the opinion of the investigator.
PSCI 23-008: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature® Status ACR-368-201/GOG-3082
This trial will be looking at patients with OncoSignature positive and negative tumors using the treatment of the study drug in combination with ultra low dose gemcitabine.
If you are in Arm 1, you will receive ACR-368 as a single intravenous (in the vein) infusion over approximately 60 minutes twice during a 4-week period, on Days 1 and 15. This entire 4-week period is called a cycle. If you are in Arm 2, you will receive gemcitabine and ACR-368 as two separate intravenous (in the vein) infusions. The gemcitabine infusion will last approximately 30 minutes and the ACR-368 infusion will last approximately 60 minutes. •Biopsy Sample and OncoSignature® Status•Archived Tumor Sample and Genomic Information•Physical Exam•Pregnancy Test if applicable•Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) Scan•Blood Sampling for CA-125 (Ovarian carcinoma only)
Subject must have histologically confirmed, locally advanced (ie, not amenable to curative surgery and/or radiation therapy) or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
Subject must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator)
Subject must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after signed informed consent.
Subject must have an estimated life expectancy of longer than 3 months.
Subject has a history of clinically meaningful coagulopathy, bleeding diathesis.
Subject had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
Subject with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent).
Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.