Combination Therapy for Breast Cancer

Recruiting at 21 trial locations

Overseen by Erica L Mayer, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This research study is studying three combinations of drugs as treatments for breast cancer. The drugs involved in this study are: * Fulvestrant * Fulvestrant with Palbociclib * Fulvestrant with Palbociclib and Avelumab

Research Team

Erica L Mayer, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults with hormone receptor positive, HER2 negative breast cancer that has worsened on or after CDK4/6 inhibitor therapy. Participants must have good performance status, normal organ and marrow function, and no prior fulvestrant treatment in the metastatic setting. Pregnant women are excluded, and effective contraception is required.

Inclusion Criteria

Your liver enzymes should be within a certain range, unless you have cancer that has spread to your liver.

Your total bilirubin level should be below a certain limit, unless you have documented Gilbert's disease.

I am using reliable birth control methods to prevent pregnancy.

Exclusion Criteria

You have had a serious allergic reaction to the study drug or any of its ingredients in the past.

I am not taking any medications that affect my heart's rhythm.

You have a current hepatitis B or hepatitis C virus infection.

Treatment Details

Interventions

• Avelumab (Immunotherapy)
• Fulvestrant (Hormone Therapy)
• Palbociclib (CDK4/6 Inhibitor)

Trial Overview The study tests three drug combinations for breast cancer: Fulvestrant alone; Fulvestrant with Palbociclib; and Fulvestrant with both Palbociclib and Avelumab. It aims to find out which combination works best for patients who've seen their disease progress after previous treatments.

Participant Groups

Group I: Fulvestrant with Palbociclib and Avelumab Experimental Treatment 3 Interventions

* Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly * Avelumab will be administered intravebously once every 2 weeks

Group II: Fulvestrant with Palbociclib Experimental Treatment 2 Interventions

* Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly

Group III: Fulvestrant Active Control 1 Intervention

-Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly

Fulvestrant is already approved in Canada, Japan for the following indications:

Approved in Canada as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Approved in Japan as Faslodex for:

• Hormone receptor-positive metastatic breast cancer
• Locally advanced breast cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University