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Pembrolizumab + Fulvestrant for Breast Cancer
Study Summary
This trial is testing the combination of pembrolizumab and fulvestrant to treat hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I have taken a pregnancy test in the last 72 hours and it was negative.I agree to follow the study's rules on preventing pregnancy.I do not have a history of severe lung disease, heart failure, or recent heart attack.I am currently being treated for an infection.I have not received a live vaccine in the last 30 days.I have recovered from side effects of my last treatment, except for hair loss.My organs are functioning well.You are allergic to pembrolizumab or any of the ingredients in it.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am 18 years old or older.My breast cancer has spread and was confirmed by a lab test.My tumor is positive for estrogen or progesterone receptors and negative for HER2.You have a detectable disease according to specific medical guidelines within the last 28 days before joining the study.I am willing to undergo a biopsy to provide a tissue sample.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have been diagnosed with HIV.I have or had lung inflammation that needed steroids.My heart is healthy as confirmed by a recent echocardiogram.I finished chemotherapy 28 days ago or targeted therapy 14 days ago.I finished any hormone or radiation therapy at least 14 days ago.You have a current active Hepatitis B or Hepatitis C infection.I have cancer that has spread to my brain or spinal cord.I have been mostly active and able to carry on all pre-disease activities without restriction recently.I have an active tuberculosis infection.I've had at most two treatments for my advanced cancer that can't be surgically removed.I have not had more than two types of chemotherapy or hormonal therapy.I have another cancer that is getting worse or needs treatment.
- Group 1: Pembrolizumab + Fulvestrant
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What other research utilizing Pembrolizumab has been conducted?
"Currently, 1093 studies are actively running for pembrolizumab and 154 of them are in the advanced stage 3. Though most trials take place within Houston, Texas there is a grand total of 41517 locations testing this treatment."
What purpose does this clinical trial intend to fulfill?
"This 36-month study aims to track the Overall Response Rate as a primary outcome. Secondary goals include Progression Free Survival (PFS) assessed by RECIST 1.1 and irRECIST, Durable Response Rate, and quantification of pembrolizumab plus fulvestrant's safety profile according to NCI Common Terminology Criteria for Adverse Events (NCI CTCAE)."
What clinical indications is Pembrolizumab most commonly employed for?
"Pembrolizumab is a common treatment for malignant neoplasms, but it can also be prescribed to address cases of unresectable melanoma, microsatellite instability high and individuals at risk of recurrence."
Is registration still open for participation in this investigation?
"Affirmative. The information hosted on clinicaltrials.gov reveals that this research trial is actively recruiting participants, as it was most recently updated on September 22nd of 2022. A total of 47 volunteers are needed across 5 sites to complete the study which began in January 2018."
What is the current enrollment size of this clinical trial?
"To conduct this trial, 47 participants who meet the qualifications need to be recruited. The sponsor for the study is Merck Sharp & Dohme LLC and it will take place across Michigan State University, Breslin Cancer Center in Lansing and New york University Clinical Cancer Centre in New York."
How widely distributed is this study in Canada?
"Patients are being enrolled at Michigan State University's Breslin Cancer Center in Lansing, New york University Clinical Cancer Center in NYC, and Rutgers Cancer Institute of New jersey. Furthermore, there are 5 additional study sites that have opened to accept participants."
What deleterious impacts may Pembrolizumab have on individuals?
"The safety rating of pembrolizumab is 2, as it has been subject to a Phase 2 trial and only preliminary evidence exists for its effectiveness."
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