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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

Pivotal Trial

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 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

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 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2310

Pembrolizumab

2017

Completed Phase 3

~2810