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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Change in cognition, as measured by Blessed Orientation-Memory-Concentration Test
Change in comorbidities, as measured by the Charlson comorbidity index
Mental Depression
+11 moreTrial 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
320 Previous Clinical Trials
290,130 Total Patients Enrolled
22 Trials studying Breast Cancer
2,884 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,925,968 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How would you assess the risk profile of fulvestrant and palbociclib for patients?
"Our experts at Power gave Treatment (fulvestrant, palbociclib) a 2 on the safety scale as this is still in Phase 2; meaning there are reports of its security but no evidence that it works."
Answered by AI
To what extent is the clinical trial being utilized by participants?
"Affirmative. As per the information hosted on clinicaltrials.gov, this medical study is actively seeking participants; it was initially posted in February 16th 2017 and has been recently revised on May 3rd 2023. The number of patients required for enrollment stands at 37, to be drawn from 4 distinct sites."
Answered by AI
Are there any remaining vacancies in this clinical trial?
"Affirmative. According to clinicaltrials.gov, this research study is currently in the process of recruiting participants who were first notified on 16th February 2017 and had their information last updated on 3rd May 2023. Altogether, 37 individuals are required from 4 different medical sites."
Answered by AI
What ailment is treated by the combination of fulvestrant and palbociclib?
"Metastatic breast cancer is commonly treated with fulvestrant and palbociclib. These two drugs may also be of use for treating pik3ca gene mutations, malignant neoplasms, and disease progression."
Answered by AI
Have any additional inquiries been conducted regarding the effectiveness of fulvestrant and palbociclib?
"There are currently 221 clinical investigations into Treatment (fulvestrant, palbociclib) with 41 of them in their final phase. Many of these trials take place in Shanghai; however, they can be found at 10750 sites worldwide."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger