Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage IB Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Prognostic Stage I Breast Cancer AJCC v8
- Unilateral Breast Carcinoma
- Prognostic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIA Breast Cancer AJCC v8
- Anatomic Stage IIB Breast Cancer AJCC v8
- Prognostic Stage IA Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- HER2 Negative Breast Adenocarcinoma
- Hormone Receptor Positive Breast Adenocarcinoma
- Invasive Breast Carcinoma
- Prognostic Stage IB Breast Cancer AJCC v8
- Prognostic Stage IIIA Breast Cancer AJCC v8
- Prognostic Stage IIIB Breast Cancer AJCC v8
- Prognostic Stage II Breast Cancer AJCC v8
- Prognostic Stage IIB Breast Cancer AJCC v8
- Multifocal Breast Carcinoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of the combination of abemaciclib and niraparib tosylate monohydrate (niraparib). II. To assess safety and tolerability of the combination of abemaciclib and niraparib in early stage HR+ breast cance...
PRIMARY OBJECTIVES: I. To determine the maximum-tolerated dose (MTD) and/or recommended phase 2 dose of the combination of abemaciclib and niraparib tosylate monohydrate (niraparib). II. To assess safety and tolerability of the combination of abemaciclib and niraparib in early stage HR+ breast cancer. SECONDARY OBJECTIVES: I. To determine clinical response to treatment. II. To determine pathologic response to treatment. III. To determine feasibility of combination as determined by no delay to standard of care breast surgery. EXPLORATORY OBJECTIVE: I. To assess occurrence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) malignancy. OUTLINE: This is a phase 1 dose-escalation study of abemaciclib in combination with niraparib followed by a dose-expansion study. Patients receive abemaciclib orally (PO) twice daily (BID) and niraparib PO once daily (QD). Treatment repeats every 28 days for up to 2-4 cycles in the absence of disease progression or unacceptable toxicity. Patients who complete 4 cycles undergo standard of care mastectomy or lumpectomy. Patients demonstrating progressive disease after only 2 cycles are switched to receive standard of care chemotherapy prior to undergoing mastectomy or lumpectomy. Patients are followed up at 30 days after date of surgery, every 3 months for the first 6 months, every 6 months for 2 years, then annually for up to 5 years from date of surgery.
Tracking Information
- NCT #
- NCT04481113
- Collaborators
- Eli Lilly and Company
- GlaxoSmithKline
- Oregon Health and Science University
- Investigators
- Principal Investigator: Zahi Mitri, MD, MS OHSU Knight Cancer Institute