Can adding immunotherapy to standard drugs fight resistant breast cancer?

NCT ID NCT03147287

Ongoing Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

First seen Nov 01, 2025 · Last updated Jun 19, 2026 · Updated 33 times

Summary

This phase 2 trial tests three drug combinations—fulvestrant alone, fulvestrant plus palbociclib, and fulvestrant plus palbociclib plus avelumab—in 220 people with ER+/HER2- metastatic breast cancer that has progressed after prior CDK inhibitor therapy. The goal is to see which combination delays cancer growth best. Participants are randomly assigned to one of the three groups.

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This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Contacts and locations

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Locations

Aurora Cancer Care

Milwaukee, Wisconsin, 53215, United States
Baylor University

Houston, Texas, 77030, United States
Boston Medical Center

Boston, Massachusetts, 02188, United States
DF/BWCC at Milford Regional Medical Center

Milford, Massachusetts, 01757, United States
DF/BWCC in clinical affiliation with South Shore Hospital

South Weymouth, Massachusetts, 02190, United States
Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States
Dana-Farber at St. Elizabeth's Medical Center

Brighton, Massachusetts, 02135, United States
Dana-Farber/New Hampshire Oncology-Hematology

Londonderry, New Hampshire, 03053, United States
Eastern Maine Medical Center

Bangor, Maine, 04401, United States
Emory University - Winship Cancer Institute

Atlanta, Georgia, 30322, United States
Indiana University

Indianapolis, Indiana, 46202, United States
Northwestern University

Chicago, Illinois, 60611, United States
The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States
The University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, 64064, United States
The University of Kansas Cancer Center - North

Kansas City, Kansas, 64154, United States
The University of Kansas Cancer Center - Overland Park

Overland Park, Kansas, 66210, United States
University of Louisville

Louisville, Kentucky, 40202, United States
University of Miami

Miami, Florida, 33136, United States
University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Washington University

St Louis, Missouri, 63110, United States

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

Palbociclib (Ibrance), Fulvestrant (Faslodex), Avelumab (Bavencio)

What this could lead to

If successful, this could point toward a new treatment option for people with advanced breast cancer whose disease has progressed after initial therapy.

What could go wrong

This is a mid-stage trial with only 220 participants, so results may not apply to everyone. The drugs can cause side effects like low blood counts, fatigue, or immune-related reactions.

Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC BREAST CANCER