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Trials
Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49)

A phase 3 trial of Pembrolizumab, Doxorubicin and Capecitabine in advanced solid tumours, run by Merck Sharp & Dohme LLC, active and no longer recruiting.

Active

Also called: KEYNOTE-B49

Overview Taking part Connected7

Overview

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) is a phase 3 interventional study registered as NCT04895358 by Merck Sharp & Dohme LLC, with 342 participants enrolled, started 2021-06-18 and due to reach its primary completion in 2026-04-24. Interventions recorded: pembrolizumab, paclitaxel, nab-paclitaxel, liposomal doxorubicin, capecitabine and normal saline.

Setting

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Pembrolizumab Plus Chemotherapy Versus Placebo Plus Chemotherapy for the Treatment of Chemotherapy-Candidate Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+/HER2-) Locally Recurrent Inoperable or Metastatic Breast Cancer (KEYNOTE-B49)

Phase

Phase 3

Sponsor

Merck Sharp & Dohme LLC

Registry

Started

2021-06-18

Enrolled

342 enrolled

Taking part

NCT04895358active not recruiting

Run by: Merck Sharp & Dohme LLC
Open to: 18 Years and over, any sex
Enrolment: 342
Sites: 256
Countries: Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Greece, Guatemala, Hungary, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Philippines, Poland, Portugal, Romania, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom, United States
Registry updated: 2026-07-22

The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.

ClinicalTrials.gov data courtesy of the US National Library of Medicine.

Connected

7

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cancers

Metastatic cancer (cancer that has spread)

technologies

Immune checkpoint inhibitors

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

ApprovedCytotoxic chemotherapy (anthracycline)

Doxorubicin · Adriamycin

ApprovedMonoclonal antibody (anti-PD-1)

Pembrolizumab · Keytruda / Keytruda Qlex (SC)

companies

Merck & Co. (MSD)

institutions

UCSF Helen Diller Family Comprehensive Cancer Center

Evidence strength48/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
342 enrolled+13
No structured primary endpoint0
Result: active0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

Make correction

Report a readout

Cancers

Metastatic cancer (cancer that has spread)

Technologies

Immune checkpoint inhibitors

Products

Pembrolizumab
Doxorubicin
Capecitabine

Companies

Merck & Co. (MSD)

Sources

Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.

ClinicalTrials.gov · 1

ClinicalTrials.gov NCT04895358

A source that has moved or gone is reported by the weekly link check. /audit/

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sourced, not expert-reviewed

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