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Chemotherapy

Pembrolizumab + Standard Therapy for Breast Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male participants must agree to use contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment and refrain from donating sperm during this period.

Has centrally confirmed ER+/HER2-, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 12 years

Awards & highlights

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.

Who is the study for?

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.Check my eligibility

What is being tested?

The trial is testing pembrolizumab's effectiveness compared to a placebo when given alongside pre-surgery chemotherapy and post-surgery endocrine therapy in treating early-stage breast cancer. Success is measured by complete response rate at surgery and event-free survival rates.See study design

What are the potential side effects?

Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), skin reactions, hormone gland problems (like thyroid disorders), infusion reactions; also possible are fatigue, nausea, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use contraception and not donate sperm for up to 12 months after treatment.

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My breast cancer is ER positive, HER2 negative, Grade 3, and of ductal type.

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My breast cancer is invasive, not just on the surface, and is a certain size or has spread to nearby lymph nodes.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My organs are functioning well.

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I have provided a recent biopsy of my breast tumor for detailed testing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 12 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 12 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 12 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Event-Free Survival (EFS)

Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0

Secondary outcome measures

Change from Baseline in EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) Score

Change from Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire Core 30 (QLQ-C30) Score

EFS in Participants With a CPS ≥1

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab+Chemotherapy (KX/KA[E]C)Experimental Treatment8 Interventions

In the neoadjuvant setting, participants receive pembrolizumab (K) 200 mg via intravenous (IV) infusion once every 3 weeks (Q3W) + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by pembrolizumab 200 mg via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive pembrolizumab 200 mg via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Group II: Placebo+Chemotherapy (PX/PA[E]C)Placebo Group7 Interventions

In the neoadjuvant setting, participants receive placebo (P; normal saline or dextrose) via IV infusion Q3W + paclitaxel (X) 80 mg/m^2 via IV infusion once weekly (QW) for 4 cycles (Treatment 1), followed by placebo via IV infusion + doxorubicin or epirubicin (A or E; 60 mg/m^2 or 100 mg/m^2) via IV infusion either in Q2W or Q3W + cyclophosphamide (C) 600 mg/m^2 via IV infusion either in Q2W or Q3W for 4 cycles (Treatment 2). At no more than 6 weeks after last cycle of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will begin adjuvant study treatment. In the adjuvant setting, participants receive placebo via IV infusion Q3W for 9 cycles + variable endocrine therapy for up to 10 years. Each cycle is 21 days long.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Endocrine therapy

2019

Completed Phase 3

~35460

Radiation therapy

2013

Completed Phase 3

~2850

Surgery

2000

Completed Phase 3

~2550

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,580,582 Total Patients Enrolled

17 Trials studying Breast Cancer

4,330 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,053,331 Total Patients Enrolled

58 Trials studying Breast Cancer

6,294 Patients Enrolled for Breast Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,240 Total Patients Enrolled

6 Trials studying Breast Cancer

503 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03725059 — Phase 3

Breast Cancer Research Study Groups: Pembrolizumab+Chemotherapy (KX/KA[E]C), Placebo+Chemotherapy (PX/PA[E]C)

Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03725059 — Phase 3

Cyclophosphamide (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03725059 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)

2018. "Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer (MK-3475-756/KEYNOTE-756)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03725059.

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