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Pembrolizumab + Chemotherapy/Anti-Estrogen for Breast Cancer
Study Summary
This trial is testing pembrolizumab with doxorubicin or anti-estrogen therapy compared to pembrolizumab alone to see if it is an effective treatment for patients with hormone-receptor positive or triple-negative breast cancer.
Timeline
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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- You have had a lung problem that was not caused by an infection and needed steroids to treat, or you currently have a lung problem.You have stage IV triple negative breast cancer or stage IV HR+ HER2- breast cancer.You have active tuberculosis, allergic reactions to pembrolizumab, or heart problems.You have a weakened immune system or have been taking strong medications that weaken your immune system within the last 7 days before starting the trial treatment.You have previously been treated with anthracycline for triple negative breast cancer.You have had or currently have a lung disease called pneumonitis or interstitial lung disease that needed treatment with steroids.You have a history of HIV or active hepatitis B or C.You are willing to give a small piece of tissue from a recent tumor biopsy.You have a disease that can be measured using a specific method called RECIST 1.1.Your blood and body chemistry levels need to be within certain ranges.Women in cohort 2 have reached menopause and have hormone receptor-positive stage IV breast cancer.You have tried all three approved aromatase inhibitors for HR+ breast cancer, but they did not work for you.You have cancer that has spread to your brain or spinal cord, unless it is not getting worse.You have had another type of cancer that got worse or needed treatment in the last 5 years, unless in certain situations.You have a serious infection that needs treatment with medication throughout your body.You have had an autoimmune disease that needed medication in the past 2 years.You have already been treated with a specific type of medication that targets the immune system.
- Group 1: Cohort 1 (pembrolizumab, doxorubicin hydrochloride)
- Group 2: Cohort 2 (pembrolizumab, anti-estrogen therapy)
- 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
Is there prior research that has investigated the efficacy of Pembrolizumab?
"As of now, 1487 clinical trials are being conducted to further investigate the efficacy and safety profile of pembrolizumab. Of those studies, 288 have reached Phase 3 development with 72045 different locations participating in their research endeavours. Shanghai is a major centre for these experiments."
What is the current enrollment number for this research program?
"Unfortunately, this trial has concluded patient recruitment. It was initially posted on March 28th 2016 and last modified October 22nd 2022. For those seeking trials with other medications, there are a combined 3778 studies that accept subjects with estrogen receptors or Pembrolizumab."
What beneficial effects are researchers hoping to achieve through this trial?
"This research endeavour hopes to measure the overall response rate of PD-L1 not enriched stage IV breast cancer when administering a combination therapy involving pembrolizumab and aromatase inhibitor (preferably exemestane). The duration of this assessment is 3 years. Secondary goals include assessing responses, calculating durations of said responses, as well as determining progression-free survival using both RECIST 1.1 and irRECIST criteria."
How many venues is this trial currently operating in?
"Six medical institutions are currently enrolling patients in this trial, including City of Hope South Pasadena, located in South Pasadena; West Covina's City of Hope; and the City of Hope Corona facility. Additionally, 3 other sites are recruiting participants for the study."
Could someone still apply to join this research project?
"This clinical trial is no longer accepting applicants. It was initially published on March 28th 2016 and last edited October 22nd 2022, therefore it has been closed to further recruitment. If you are looking for other trials related to estrogen receptors or Pembrolizumab, there are currently 2,291 and 1,487 respective studies that are actively enrolling participants."
What is the risk profile associated with Pembrolizumab?
"Although there are some data indicating Pembrolizumab's safety, the lack of efficacy-related evidence warrants a score 2 on our team at Power's scale."
What types of conditions can Pembrolizumab ameliorate?
"Pembrolizumab is widely utilized to treat cases of unresectable melanoma. It may also serve as a therapeutic option for microsatellite instability high, nb (neuroblastoma), and instances involving an increased danger of recurrence."
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