This phase I trial tests the side effects and best dose of abemaciclib and niraparib in
treating patients with breast cancer that is positive for estrogen or progesterone receptors
(hormone receptor positive [HR+]) and HER2 negative. Abemaciclib may stop the growth of tumor
cells by blocking certain proteins called cyclin-dependent kinases, which are needed for cell
growth. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as
niraparib, can keep PARP from working so tumor cells can't repair themselves and grow. Giving
abemaciclib and niraparib together before surgery may make the tumor smaller.
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.
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.
I. To assess occurrence of secondary myelodysplastic syndrome (MDS)/acute myeloid leukemia
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.
Invasive Breast Carcinoma,
Invasive Breast Cancer,
Multifocal Breast Carcinoma,
Unilateral Breast Carcinoma,
Anatomic Stage IIIA Breast Cancer AJCC v8,
Prognostic Stage IIIA Breast Cancer AJCC v8,
Prognostic Stage IIIB Breast Cancer AJCC v8,
Anatomic Stage II Breast Cancer AJCC v8,
Anatomic Stage IIA Breast Cancer AJCC v8,
Anatomic Stage IIB Breast Cancer AJCC v8,
Prognostic Stage II Breast Cancer AJCC v8,
Prognostic Stage IIA Breast Cancer AJCC v8,
Prognostic Stage IIB Breast Cancer AJCC v8,
Anatomic Stage I Breast Cancer AJCC v8,
Anatomic Stage IA Breast Cancer AJCC v8,
Anatomic Stage IB Breast Cancer AJCC v8,
Prognostic Stage I Breast Cancer AJCC v8,
Prognostic Stage IA Breast Cancer AJCC v8,
Prognostic Stage IB Breast Cancer AJCC v8,
multifocal breast cancer,
unilateral breast cancer,
HER2 Negative Breast Adenocarcinoma,
Hormone Receptor Positive Breast Adenocarcinoma
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.