Pembrolizumab + Standard Therapy for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive therapy or steroids, you may need to stop, as these are part of the exclusion criteria.
What data supports the effectiveness of the drug combination used in the Pembrolizumab + Standard Therapy for Breast Cancer trial?
Research shows that using taxane-based drugs like paclitaxel before anthracycline-based drugs like epirubicin and cyclophosphamide can lead to high response rates in breast cancer patients. Additionally, doxorubicin, a key component of the treatment, has historically been effective in treating metastatic breast cancer, especially when combined with other active agents.12345
Is the combination of Pembrolizumab and standard therapy for breast cancer safe?
Studies have shown that nab-paclitaxel, a form of paclitaxel, has a better safety profile compared to conventional paclitaxel, and pegylated liposomal doxorubicin combined with cyclophosphamide is considered safe in metastatic breast cancer. Additionally, non-pegylated liposomal doxorubicin with cyclophosphamide followed by paclitaxel showed no significant cardiac events in elderly patients. These findings suggest that components of the standard therapy have been evaluated for safety in breast cancer treatment.46789
What makes the drug Pembrolizumab + Standard Therapy unique for breast cancer treatment?
Pembrolizumab combined with standard chemotherapy drugs like Cyclophosphamide, Doxorubicin, Epirubicin, and Paclitaxel offers a novel approach by incorporating an immunotherapy component (Pembrolizumab) that helps the immune system recognize and attack cancer cells, which is different from traditional chemotherapy that directly targets cancer cells.1011121314
What is the purpose of this trial?
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.The primary study hypotheses are: 1) pembrolizumab is superior to placebo, both in combination with the protocol-specified neoadjuvant anticancer therapy, as assessed by pathological Complete Response (pCR) rate defined by the local pathologist, and 2) pembrolizumab is superior to placebo (both in combination with the protocol-specified neoadjuvant and adjuvant anticancer therapies) as assessed by Event-Free Survival (EFS) as determined by the investigator. The study is considered to have met its primary objective if pembrolizumab is superior to placebo with respect to either pCR (ypT0/Tis ypN0) or EFS.
Research Team
Medical Director
Principal Investigator
Merck Sharp & Dohme LLC
Eligibility Criteria
Adults with high-risk early-stage ER+/HER2- breast cancer, confirmed by a pathologist, who have not received prior treatment for it. Participants must have adequate organ function and an ECOG performance status of 0 or 1. Men and women must agree to use contraception during the study and for some time after. Exclusions include those with certain heart diseases, active infections like hepatitis B/C or tuberculosis, HIV, other cancers within the last five years (except specific non-invasive types), previous immunotherapy treatments, severe allergies to study drugs' components.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Treatment
Participants receive neoadjuvant chemotherapy with either pembrolizumab or placebo in combination with paclitaxel, doxorubicin or epirubicin, and cyclophosphamide for 8 cycles
Surgery
Participants undergo surgery for breast cancer after completion of neoadjuvant treatment
Adjuvant Treatment
Participants receive adjuvant therapy with either pembrolizumab or placebo for 9 cycles and variable endocrine therapy for up to 10 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Doxorubicin
- Endocrine therapy
- Epirubicin
- Paclitaxel
- Pembrolizumab
- Placebo
- Radiation therapy
- Surgery
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme Corp.
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme Corp.
Chief Medical Officer
Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme Corp.
Chief Executive Officer since 2021
J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Merck Sharp & Dohme LLC
Lead Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University