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Estrogen Receptor Antagonist

Hormone Therapy for Breast Cancer

Phase 2

Recruiting

Led By Bhuvaneswari Ramawamy, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed invasive, estrogen receptor (ER) and/or progesterone receptor (PR)-positive, HER2 negative breast cancer; ER-and/or PR-positive breast cancer is defined by > 10% staining by immunohistochemistry

The patient's refusal to proceed with curative breast surgery has to be documented by the surgeon's and medical oncologist's note

Must not have

Evidence of distant metastases

Patients receiving strong inducers or inhibitors of cytochrome P450 3A4 (CYP3A4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is studying a combination of drugs to treat older patients with hormone-responsive breast cancer that can't be removed surgically.

Who is the study for?

This trial is for older patients with hormone-responsive breast cancer that can't be surgically removed. Participants must have normal levels of bilirubin, creatinine, and liver enzymes, not have had prior aromatase inhibitor therapy or strong CYP3A4 drugs, and no distant metastases. They should also meet certain health criteria indicating they are vulnerable or frail according to Balducci Criteria.

What is being tested?

The study tests the effectiveness of combining fulvestrant (a hormone therapy) with palbociclib (an enzyme blocker) in treating estrogen-receptor-positive breast cancer. The goal is to see if this combination helps stop tumor growth by blocking estrogen use and cell growth enzymes.

What are the potential side effects?

Potential side effects may include but are not limited to nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, liver function alterations, and possible interactions with other medications affecting enzyme activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER/PR positive and HER2 negative, with more than 10% staining.

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I have chosen not to undergo surgery for my breast cancer, as noted by my surgeon and oncologist.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to distant parts of my body.

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I am not taking medication that strongly affects liver enzyme CYP3A4.

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I have previously been treated with aromatase inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment failure-free survival (TFFS) defined as the proportion of study subjects who remain on treatment from the 1st day of therapy to one year

Secondary study objectives

Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test

Change in comorbidities, as measured by the Charlson comorbidity index

Mental Depression

+11 more

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (fulvestrant, palbociclib)Experimental Treatment5 Interventions

Patients receive fulvestrant IM on days 1 and 15. Patients also receive palbociclib PO QD on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

FDA approved

Palbociclib

FDA approved

Aromatase Inhibitors

2020

Completed Phase 3

~490