NCT03449238 is a Phase 1, PHASE2 clinical trial of Pembrolizumab in Metastatic Breast Cancer, sponsored by Weill Medical College of Cornell University.

Who is sponsoring NCT03449238?

NCT03449238 is sponsored by Weill Medical College of Cornell University.

What drugs are being tested in NCT03449238?

Interventions in NCT03449238: Pembrolizumab.

What condition does NCT03449238 study?

NCT03449238 studies Metastatic Breast Cancer, Brain Metastases.

Is NCT03449238 still recruiting?

NCT03449238 is currently recruiting now. Last updated 30 March 2026.

Last reviewed 2026-03-30 · How we verify

NCT03449238

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pembrolizumab And Stereotactic Radiosurgery (Srs) Of Selected Brain Metastases In Breast Cancer Patients

Recruiting now Phase 1, PHASE2 Last updated 30 March 2026

What this trial tests

Phase 1, PHASE2 trial testing Pembrolizumab in Metastatic Breast Cancer in 41 participants. Currently enrolling.

Timeline

15 November 2018

Primary endpoint
31 December 2028

31 December 2030

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	15 November 2018
Primary completion	31 December 2028
Estimated completion	31 December 2030
Sites	3 locations across United States

Drugs / interventions tested

Pembrolizumab (pembrolizumab) — full drug profile →

Conditions studied

Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Brain Metastases — all drugs for Brain Metastases →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 19 to 90, female only, with Metastatic Breast Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with metastatic breast cancer with at least 2 brain metastases will receive pembrolizumab every 3 weeks. Patients will undergo stereotactic radiosurgery (SRS) to one of the brain lesions. Pembrolizumab infusion will be given on Day 4 (+/-1) after SRS treatment at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment strategies for breast cancer brain metastases.
Bailleux C, Eberst L, Bachelot T. · · 2021 · cited 170× · PMID 33250512 · DOI 10.1038/s41416-020-01175-y
Breast cancer brain metastasis: insight into molecular mechanisms and therapeutic strategies.
Wang Y, Ye F, Liang Y, Yang Q. · · 2021 · cited 99× · PMID 34226684 · DOI 10.1038/s41416-021-01424-8
Immunotherapy of brain metastases: breaking a "dogma".
Di Giacomo AM, Valente M, Cerase A, Lofiego MF, et al · · 2019 · cited 69× · PMID 31623643 · DOI 10.1186/s13046-019-1426-2
Breast Cancer Brain Metastasis-Overview of Disease State, Treatment Options and Future Perspectives.
Watase C, Shiino S, Shimoi T, Noguchi E, et al · · 2021 · cited 68× · PMID 33802424 · DOI 10.3390/cancers13051078
Immunotherapy of Primary Brain Tumors: Facts and Hopes.
Buerki RA, Chheda ZS, Okada H. · · 2018 · cited 63× · PMID 29871908 · DOI 10.1158/1078-0432.ccr-17-2769
The abscopal effect in patients with cancer receiving immunotherapy.
Nelson BE, Adashek JJ, Lin SH, Subbiah V. · · 2023 · cited 46× · PMID 36893753 · DOI 10.1016/j.medj.2023.02.003
Breast cancer brain metastasis: Current evidence and future directions.
Sun H, Xu J, Dai S, Ma Y, et al · · 2023 · cited 46× · PMID 35822637 · DOI 10.1002/cam4.5021
Breast Cancer Brain Metastasis: A Comprehensive Review.
Raghavendra AS, Ibrahim NK. · · 2024 · cited 45× · PMID 38748968 · DOI 10.1200/op.23.00794

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07275216 — Pembrolizumab in Combination With Chemotherapy for the Treatment of Frail Hodgkin Lymphoma Patients Ineligible for Stand · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting

Other recruiting trials for Metastatic Breast Cancer

Currently open trials in the same condition.

NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting

Other Weill Medical College of Cornell University trials

Trials by the same sponsor.

NCT07485712 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 2 · NA · not yet recruiting
NCT05811338 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 1 · NA · not yet recruiting
NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
NCT06818734 — Implementation of a Clinical Decision Support Tool for Postpartum Depression · NA · not yet recruiting
NCT07485725 — Center for Research and Education on Aging and Technology Enhancement - CREATE V - Project 3 · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03449238 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Weill Medical College of Cornell University
Last refreshed: 30 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03449238.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing