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Pembrolizumab + Standard Therapy for Breast Cancer
Study Summary
This trial is testing whether the cancer drug pembrolizumab is more effective than placebo when given with standard neoadjuvant and adjuvant therapy for high-risk early-stage ER+/HER2- breast cancer. The primary objectives are to compare pembrolizumab to placebo in terms of pathological complete response rate and event-free survival.
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.Trial Design
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Who is running the clinical trial?
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- I haven't used any experimental drugs or devices within the last 4 weeks, or 12 months if they were for cancer.I have an active tuberculosis infection.My breast cancer is estrogen receptor-negative and progesterone receptor-positive.I agree to use contraception and not donate sperm for up to 12 months after treatment.I am currently being treated for an infection.I have or had lung inflammation treated with steroids.I have been treated with specific immune system drugs for cancer.I have not received a live vaccine in the last 30 days.I have more than one tumor in different areas of my breast.I have not needed strong medication for an autoimmune disease in the last 2 years.I have had a biopsy of my tumor or lymph nodes before starting the study treatment.My breast cancer is ER positive, HER2 negative, Grade 3, and of ductal type.My breast cancer is invasive, not just on the surface, and is a certain size or has spread to nearby lymph nodes.I am fully active or restricted in physically strenuous activity but can do light work.I have cancer in both of my breasts.I have had serious heart issues, like a heart attack or heart failure, recently.I am on high-dose steroids or other drugs that weaken my immune system.My breast cancer has spread to nearby lymph nodes.I have not had active treatment for another cancer, except for certain skin or early stage breast or cervical cancers, in the last 5 years.My breast cancer has spread to other parts of my body.My breast cancer is of the lobular type.I have been diagnosed with HIV.I have a history of hepatitis B or an active hepatitis C infection.My organs are functioning well.My heart's pumping ability is below normal.I have previously been treated for breast cancer.I have provided a recent biopsy of my breast tumor for detailed testing.
- Group 1: Placebo+Chemotherapy (PX/PA[E]C)
- Group 2: Pembrolizumab+Chemotherapy (KX/KA[E]C)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are there any other scientific papers that explore endocrine treatments?
"Endocrine therapy was first researched in 1997 at Spectrum Health Hospital - Butterworth Campus. So far, there have been 2801 completed clinical trials related to this topic. Right now, there are 2647 active studies being conducted; a large portion of these taking place in Montreal, Quebec."
How many people are involved in this trial total?
"This study is not enrolling new patients at the moment. The trial was originally posted on December 27th, 2018 and was most recently edited on July 27th, 2022. However, there are presently 2695 clinical trials actively looking for participants with breast cancer and 2647 trials for Endocrine therapy that need patients."
What is the most common reason for a doctor to prescribe Endocrine therapy?
"Endocrine therapy, which is often used to treat melanoma, can also be effective in combating neoplasm metastasis, malignant melanoma of skin, and corticotropin."
Is this study the first of its kind?
"Endocrine therapy has been researched since 1997, when Alfacell first sponsored a trial. After the initial study of 300 patients in 1997, Endocrine Therapy received Phase 3 drug approval. Nowadays, there are 2647 active trials for this medication taking place in 83 different nations and 4270 cities."
Are there any clinical trial locations in Canada?
"This study has many hospitals participating, such as Jewish General Hospital (Site 0103) in Montreal, Quebec, Midwestern Regional Medical Center, Inc. ( Site 0077) in Zion, Illinois, and Centre Hospitalier Regional de Trois-Rivieres ( Site 0106) in Trois-Rivières, Massachusetts. In total, there are 40 other locations where this trial is taking place."
Are there side effects to hormone therapy that people should be aware of?
"There is already some evidence of efficacy from phase 3 trials as well as additional safety data, so endocrine therapy received a score of 3."
Are researchers still looking for participants for this experiment?
"Unfortunately, this particular trial is not currently looking for participants. Although, it was last updated on 7/27/2022, the original posting date was 12/27/2018. There are 5342 other trials that might be a better match for you and your needs."
Why was this clinical trial designed, and what are its goals?
"The goal of this long-term study is to assess the Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 in patients. Secondary outcomes include pCR Rate Using the Definitions of ypT0/Tis ypN0, ypT0/Tis, and ypT0 ypN0 in Participants With a Combined Positive Score [CPS] ≥1 as well as overall survival rates in participants with a CPS ≥1. The study will also track the number of participants experiencing an adverse event (AE)."
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