Your session is about to expire
← Back to Search
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 belowSelect...
My breast cancer is ER/PR positive and HER2 negative, with more than 10% staining.
Select...
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:Select...
My cancer has spread to distant parts of my body.
Select...
I am not taking medication that strongly affects liver enzyme CYP3A4.
Select...
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
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 moreAwards & 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
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
340 Previous Clinical Trials
293,273 Total Patients Enrolled
23 Trials studying Breast Cancer
2,902 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,943 Previous Clinical Trials
41,024,664 Total Patients Enrolled
943 Trials studying Breast Cancer
1,443,257 Patients Enrolled for Breast Cancer
Bhuvaneswari Ramawamy, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to distant parts of my body.I am not taking medication that strongly affects liver enzyme CYP3A4.I am considered vulnerable or frail due to health issues, or I am refusing breast surgery.I have chosen not to undergo surgery for my breast cancer, as noted by my surgeon and oncologist.Your blood creatinine level is higher than what is considered normal at the hospital.Your total bilirubin level should be less than 1.5 times the upper limit of normal.Your AST or ALT levels are 2.5 times higher than the upper limit of normal.My breast cancer is ER/PR positive and HER2 negative, with more than 10% staining.I have previously been treated with aromatase inhibitors.Your platelet count is higher than 75,000 per microliter.Your body has enough infection-fighting white blood cells.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (fulvestrant, palbociclib)
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.