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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 8 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 8 years

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

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

Primary outcome measures

Event-free Survival (EFS) as assessed by Investigator

Breast

Secondary outcome measures

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

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

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

Pembrolizumab

2017

Completed Phase 2

~2010

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Doxorubicin

2012

Completed Phase 3

~7940

Epirubicin

2012

Completed Phase 4

~19470

Cyclophosphamide

1995

Completed Phase 3

~3780

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,580,648 Total Patients Enrolled

18 Trials studying Breast Cancer

5,570 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,053,397 Total Patients Enrolled

59 Trials studying Breast Cancer

7,534 Patients Enrolled for Breast Cancer

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,306 Total Patients Enrolled

7 Trials studying Breast Cancer

1,743 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

Frequently Asked Questions

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

What are the research objectives of this clinical trial?

"The primary outcome of this clinical trial is Event-free Survival (EFS) as assessed by Investigator, which will be evaluated over a Up to approximately 27-30 weeks time frame. Secondary outcomes include pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery, defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed"

Answered by AI

Is it possible to sign up for this experiment right now?

"This research is not currently enrolling new patients. The study was originally posted on March 7th, 2017 and last updated on July 8th, 2022. However, there are 2436 other trials related to triple negative breast neoplasms that are actively recruiting and 2979 for Pembrolizumab if you're interested in participating in active clinical trials."

Answered by AI

Is this a new clinical trial?

"Since 1997, when the first study occurred in sponsored by Alfacell, Pembrolizumab has been researched. The drug went through Phase 3 approval after the initial 300-person trial in 1997. As of now, there are 2979 active studies involving Pembrolizumab across 4472 cities and 88 countries."

Answered by AI

How many locations are conducting this research?

"Presently, patients are being accepted at Christiana Hospital (Site 0029) in Newark, Delaware; Nyack Hospital Infusion Center (Site 0059) in Nyack, New york; Oncology Hematology Care, Inc. (Site 8011) in Cincinnati, Ohio; and 54 other locations."

Answered by AI

What is the standard Pembrolizumab dosage for patients?

"Pembrolizumab, while most commonly used to treat melanoma, can also help patients suffering from neoplasm metastasis, malignant melanoma of skin, and corticotropin."

Answered by AI

How many people are in this experiment?

"This particular study is no longer looking for patients to enroll. However, there are 2436 trials currently recruiting patients with triple negative breast neoplasms and 2979 trials actively recruiting patients that hope to receive Pembrolizumab."

Answered by AI

Has Pembrolizumab been cleared for therapeutic use in the United States?

"The safety of Pembrolizumab is thought to be high as it is a Phase 3 trial, meaning there is both evidence of efficacy and multiple rounds data supporting safety."

Answered by AI

What other types of research has been conducted using Pembrolizumab?

"Pembrolizumab was first studied in 1997 at Spectrum Health Hospital - Butterworth Campus. 21532 trials have been completed to date, with 2979 active clinical trials presently underway - many of which are based in Newark, Delaware."

Answered by AI