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Chemotherapy

Pembrolizumab + Chemotherapy for Triple Negative 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
Has previously untreated locally advanced non-metastatic (M0) TNBC defined as specific combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment
Has newly diagnosed, locally advanced, centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
Must not have
Has an active infection requiring systemic therapy
Has a known history of active tuberculosis (TB, Bacillus Tuberculosis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 8 years
Awards & highlights

Summary

This trial is testing a new cancer treatment of pembrolizumab (MK-3475) combined with chemotherapy vs. chemotherapy alone in participants who have triple negative breast cancer.

Who is the study for?
This trial is for adults with untreated, locally advanced triple negative breast cancer (TNBC) without metastasis. Participants must have good performance status, adequate organ function, and agree to use contraception. Excluded are those with hypersensitivities, HIV, active infections or significant heart disease; recent participants in other trials; pregnant or breastfeeding women; and those with certain medical histories.
What is being tested?
The study tests if pembrolizumab combined with chemotherapy is more effective than placebo plus chemotherapy before surgery (neoadjuvant therapy), and if pembrolizumab alone is better than placebo after surgery (adjuvant therapy) in improving survival rates and reducing cancer recurrence in TNBC patients.
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation of organs, infusion reactions like fever or chills, fatigue, skin rash, digestive issues including nausea and diarrhea. Chemotherapy can lead to hair loss, increased risk of infection due to low blood cell counts, mouth sores and potential damage to the heart.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My triple-negative breast cancer has not spread beyond my breast and nearby lymph nodes.
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I have been recently diagnosed with a specific type of aggressive breast cancer.
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My cancer is large but has not spread beyond nearby lymph nodes.
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I have provided at least 2 separate samples from my tumor for testing.
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My cancer has spread to nearby tissues but not to distant body parts.
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My cancer is at stage T2, with possible lymph node involvement up to N2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently being treated for an infection.
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I have an active tuberculosis infection.
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I haven't had cancer, except for certain skin or cervical cancers, in the last 5 years.
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I have not received a live vaccine in the last 30 days.
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I have been diagnosed with HIV.
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I have had pneumonitis treated with steroids or have it now.
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I have been treated for an autoimmune disease in the last 2 years.
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I have a serious heart condition.
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I've had chemotherapy, targeted therapy, or radiation in the last year.
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I have been treated with specific immunotherapy or was in a certain clinical study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free Survival (EFS) as assessed by Investigator
Breast
Secondary study objectives
EFS in participants with tumors expressing PD-L1
EORTC Breast Cancer-Specific QoL Questionnaire (QLQ-BR23) score
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 Questionnaire (QLQ-C30) score
+6 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + ChemotherapyExperimental Treatment7 Interventions
Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.
Group II: Placebo + ChemotherapyActive Control7 Interventions
Participants receive placebo (normal saline solution) Q3W + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by placebo + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of placebo Q3W as adjuvant therapy post-surgery. Each cycle is 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Pembrolizumab
2017
Completed Phase 2
~2070
Paclitaxel
2011
Completed Phase 4
~5810
Epirubicin
2012
Completed Phase 4
~19470
Carboplatin
2014
Completed Phase 3
~6120
Doxorubicin
2012
Completed Phase 3
~8030

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,405 Total Patients Enrolled
18 Trials studying Breast Cancer
5,570 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,173,809 Total Patients Enrolled
59 Trials studying Breast Cancer
7,408 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,606 Total Patients Enrolled
8 Trials studying Breast Cancer
5,963 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03036488 — Phase 3
Breast Cancer Research Study Groups: Pembrolizumab + Chemotherapy, Placebo + Chemotherapy
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03036488 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03036488 — Phase 3
~138 spots leftby Sep 2025
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