Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer

Summary

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.

Conditions

• Anatomic Stage I Breast Cancer AJCC v8
• Anatomic Stage IA Breast Cancer AJCC v8
• Anatomic Stage IB 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
• Anatomic Stage IIIA Breast Cancer AJCC v8
• HER2 Negative Breast Adenocarcinoma
• Hormone Receptor Positive Breast Adenocarcinoma
• Invasive Breast Carcinoma
• Multifocal Breast Carcinoma
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB 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
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Unilateral Breast Carcinoma

Interventions

DRUG

Abemaciclib

Given PO

DRUG

Niraparib Tosylate Monohydrate

Given PO

Sponsors & Collaborators

• Eli Lilly and Company

  collaborator INDUSTRY

• GlaxoSmithKline

  collaborator INDUSTRY

• Oregon Health and Science University

  collaborator OTHER

• OHSU Knight Cancer Institute

  lead OTHER

Principal Investigators

• Alexandra Zimmer, M.D. · OHSU Knight Cancer Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-07

Primary Completion

2023-10-11

Completion

2025-06-20

FDA Drug

Yes

Countries

• United States

Study Locations