8 Participants Needed

Abemaciclib + Niraparib for Breast Cancer

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you can continue taking corticosteroids if your dose is stable for at least 4 weeks before starting the trial. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination Abemaciclib and Niraparib for breast cancer?

Niraparib, a part of the drug combination, has shown improved progression-free survival in ovarian cancer patients and is approved for certain ovarian cancers. Additionally, PARP inhibitors like Niraparib have shown potential in breast cancer, especially in patients with specific genetic mutations, suggesting possible benefits in combination therapies.12345

What safety data exists for Abemaciclib and Niraparib in humans?

Niraparib has been studied for safety in patients with prostate cancer, showing it can be combined with other treatments, but specific safety data for the combination of Abemaciclib and Niraparib in breast cancer is not available from the provided research.12367

How is the drug combination of Abemaciclib and Niraparib unique for breast cancer treatment?

The combination of Abemaciclib and Niraparib is unique because it combines a CDK4/6 inhibitor (Abemaciclib) with a PARP inhibitor (Niraparib), potentially offering a novel approach to treating breast cancer by targeting different pathways involved in cancer cell growth and repair, which is different from standard treatments that typically focus on hormone receptor pathways alone.89101112

What is the purpose of this trial?

This trial tests the safety and best dose of two drugs, abemaciclib and niraparib, in patients with a specific type of breast cancer. Abemaciclib blocks proteins needed for cancer cell growth, and niraparib prevents cancer cells from fixing themselves. The goal is to shrink the tumor. Abemaciclib is an orally administered drug approved for treating advanced or metastatic breast cancer.

Research Team

AZ

Alexandra Zimmer, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Eligibility Criteria

This trial is for individuals with hormone receptor positive, HER2 negative breast cancer who haven't had prior cancer treatment (except endocrine therapy) and are planning surgery. They must have satisfactory lab results, agree to use contraception if applicable, not be pregnant or breastfeeding, and can't have certain heart conditions or a history of other cancers within the last 5 years.

Inclusion Criteria

I am fully active or can carry out light work.
I had cancer before, was treated with the intent to cure, and have been cancer-free for over 5 years.
I am scheduled for chemotherapy before surgery.
See 13 more

Exclusion Criteria

My cancer has spread to other parts of my body.
I haven't had any cancer except for certain types in the last 5 years.
I have received treatments like surgery or chemotherapy for my cancer before joining this study.
See 16 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive abemaciclib and niraparib orally. Treatment repeats every 28 days for up to 2-4 cycles.

8-16 weeks
4-8 visits (in-person)

Surgery

Participants undergo standard of care mastectomy or lumpectomy after completing treatment cycles.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery. Follow-up occurs at 30 days post-surgery, every 3 months for the first 6 months, every 6 months for 2 years, then annually for up to 5 years.

5 years

Treatment Details

Interventions

  • Abemaciclib
  • Niraparib Tosylate Monohydrate
Trial Overview The trial tests the combination of two drugs before surgery: Abemaciclib which blocks proteins needed for cell growth, and Niraparib which prevents tumor cells from repairing DNA damage. The goal is to see how well these work together to shrink tumors in patients with specific types of breast cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (abemaciclib, niraparib)Experimental Treatment2 Interventions
Patients receive abemaciclib PO BID and niraparib PO 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.

Abemaciclib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Verzenio for:
  • Hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer
🇪🇺
Approved in European Union as Verzenio for:
  • HR+, HER2- advanced or metastatic breast cancer
  • HR+, HER2- node-positive early breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials
239
Recruited
2,089,000+

GlaxoSmithKline

Industry Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Eli Lilly and Company

Industry Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Findings from Research

Niraparib has been approved by the FDA for patients with complete or partial response to first-line platinum-based chemotherapy, regardless of their BRCAm or HRD status, expanding treatment options for more patients.
Olaparib, in combination with bevacizumab, has also received FDA approval for patients with epithelial ovarian cancer, indicating that PARP inhibitors are now beneficial not only for BRCAm and HRD-deficient patients but also for those with HRD-proficient tumors.
PARP inhibitors in the treatment of ovarian cancer: a review.Washington, CR., Moore, KN.[2023]
Niraparib at a dose of 200 mg/day was determined to be the recommended phase 2 dose when combined with abiraterone acetate plus prednisone (AAP) for patients with metastatic castration-resistant prostate cancer (mCRPC), as it showed a tolerable safety profile with no new safety signals.
The combination of niraparib with apalutamide resulted in a higher incidence of dose-limiting toxicities, leading to the decision not to further evaluate this combination, highlighting the importance of monitoring drug interactions in treatment regimens.
Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE).Saad, F., Chi, KN., Shore, ND., et al.[2021]
Niraparib, a recently approved treatment for recurrent platinum-sensitive ovarian cancer, has demonstrated a high oral bioavailability of 72.7% in humans, indicating effective absorption when taken orally.
The study involved six patients who received a therapeutic dose of 300 mg of niraparib, followed by a small intravenous dose to measure its levels in the bloodstream, confirming its potential as a convenient oral treatment option.
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients.van Andel, L., Rosing, H., Zhang, Z., et al.[2019]

References

PARP inhibitors in the treatment of ovarian cancer: a review. [2023]
Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). [2021]
Determination of the absolute oral bioavailability of niraparib by simultaneous administration of a 14C-microtracer and therapeutic dose in cancer patients. [2019]
Olaparib for advanced breast cancer. [2021]
Update on PARP Inhibitors in Breast Cancer. [2021]
Neoadjuvant paclitaxel/olaparib in comparison to paclitaxel/carboplatinum in patients with HER2-negative breast cancer and homologous recombination deficiency (GeparOLA study). [2021]
Niraparib for Advanced Breast Cancer with Germline BRCA1 and BRCA2 Mutations: the EORTC 1307-BCG/BIG5-13/TESARO PR-30-50-10-C BRAVO Study. [2023]
Abemaciclib: A Review in Early Breast Cancer with a High Risk of Recurrence. [2023]
Abemaciclib: First Global Approval. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
nextMONARCH: Abemaciclib Monotherapy or Combined With Tamoxifen for Metastatic Breast Cancer. [2021]
[Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. [2021]
Cost-effectiveness analysis of abemaciclib with endocrine therapy (ET) versus ET alone for HR+, HER2-, node-positive, high-risk early breast cancer in Italy. [2023]
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