Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
Public ClinicalTrials.gov record NCT04481113. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of Abemaciclib and Niraparib as Neoadjuvant Therapy in Hormone Receptor Positive (HR+) HER2 Negative (HER2-) Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04481113
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 8 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 6, 2021
- Primary completion
- Oct 10, 2023
- Completion
- Jun 19, 2025
- Last update posted
- Jan 28, 2026
2021 – 2025
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04481113, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2026 · Synced Sep 15, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04481113 live on ClinicalTrials.gov.