Who is sponsoring NCT03524170?

NCT03524170 is sponsored by M.D. Anderson Cancer Center.

What drugs are being tested in NCT03524170?

Interventions in NCT03524170: Bintrafusp Alfa, Radiation Therapy.

What condition does NCT03524170 study?

NCT03524170 studies Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8.

Is NCT03524170 still recruiting?

NCT03524170 is currently completed. Last updated 7 March 2022.

Last reviewed 2022-03-07 · How we verify

NCT03524170

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

Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

Completed Phase 1 Last updated 7 March 2022

What this trial tests

Phase 1 trial testing Bintrafusp Alfa in Anatomic Stage IV Breast Cancer AJCC v8 in 24 participants. Completed in 10 February 2022.

Timeline

30 April 2018

Primary endpoint
10 February 2022

10 February 2022

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	24
Start date	30 April 2018
Primary completion	10 February 2022
Estimated completion	10 February 2022
Sites	1 location across United States

Drugs / interventions tested

Bintrafusp Alfa — full drug profile →
Radiation Therapy — full drug profile →

Conditions studied

Anatomic Stage IV Breast Cancer AJCC v8 — all drugs for Anatomic Stage IV Breast Cancer AJCC v8 →
Metastatic Breast Carcinoma — all drugs for Metastatic Breast Carcinoma →
Prognostic Stage IV Breast Cancer AJCC v8 — all drugs for Prognostic Stage IV Breast Cancer AJCC v8 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Anatomic Stage IV Breast Cancer AJCC v8 or Metastatic Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of anti-PD-L1/TGFbetaRII fusion protein M7824 (M7824) when given together with radiation therapy in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other parts of the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. M7824 is a drug that targets specific proteins on immune cells in order to activate immune responses against tumor cells. Giving M7824 together with radiation therapy may work better in treating patients with breast cancer.

Publications & conference data

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

Novel therapies emerging in oncology to target the TGF-β pathway.
Kim BG, Malek E, Choi SH, Ignatz-Hoover JJ, et al · · 2021 · cited 336× · PMID 33823905 · DOI 10.1186/s13045-021-01053-x
Targeting TGFβ signal transduction for cancer therapy.
Liu S, Ren J, Ten Dijke P. · · 2021 · cited 302× · PMID 33414388 · DOI 10.1038/s41392-020-00436-9
Targeting cytokine and chemokine signaling pathways for cancer therapy.
Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
Cancer-associated fibroblasts in breast cancer: Challenges and opportunities.
Hu D, Li Z, Zheng B, Lin X, et al · · 2022 · cited 206× · PMID 35481621 · DOI 10.1002/cac2.12291
The Crosstalk Between Tumor Cells and the Immune Microenvironment in Breast Cancer: Implications for Immunotherapy.
Salemme V, Centonze G, Cavallo F, Defilippi P, et al · · 2021 · cited 194× · PMID 33777750 · DOI 10.3389/fonc.2021.610303
TGF-β signaling in the tumor metabolic microenvironment and targeted therapies.
Shi X, Yang J, Deng S, Xu H, et al · · 2022 · cited 188× · PMID 36115986 · DOI 10.1186/s13045-022-01349-6
Radiotherapy as a tool to elicit clinically actionable signalling pathways in cancer.
Petroni G, Cantley LC, Santambrogio L, Formenti SC, et al · · 2022 · cited 154× · PMID 34819622 · DOI 10.1038/s41571-021-00579-w
If we build it they will come: targeting the immune response to breast cancer.
Gatti-Mays ME, Balko JM, Gameiro SR, Bear HD, et al · · 2019 · cited 152× · PMID 31700993 · DOI 10.1038/s41523-019-0133-7

Verify or expand the search:

Other trials of Bintrafusp Alfa

Trials testing the same drug.

NCT04708470 — A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, · Phase 1, PHASE2 · active not recruiting
NCT04708067 — Hypofractionated Radiation Therapy and Bintrafusp Alfa for the Treatment of Advanced Intrahepatic Cholangiocarcinoma · Phase 1 · active not recruiting
NCT04971187 — Bintrafusp Alfa With Chemotherapy for Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small Cell Lung Cancer · Phase 2 · terminated
NCT04756505 — Immunotherapy (NHS-IL12 & Bintrafusp Alfa) and Radiation Therapy for the Treatment of Hormone Receptor Positive, HER2 Ne · Phase 1 · withdrawn
NCT04789668 — Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases · Phase 1, PHASE2 · terminated

Other recruiting trials for Anatomic Stage IV Breast Cancer AJCC v8

Currently open trials in the same condition.

NCT07137416 — Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for H · Phase 1 · recruiting
NCT06860815 — Cemiplimab and Transarterial Radioembolization With Y-90 SIR-S Spheres for the Treatment of Liver Directed Metastatic Br · Phase 2 · recruiting
NCT07078604 — A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negati · Phase 2 · recruiting
NCT06434064 — Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advan · Phase 2 · recruiting
NCT06502691 — [18F]FTT Positron Emission Tomography for the Measurement of PARP Tumor Expression in Patients With Metastatic Breast Ca · Phase 1, PHASE2 · recruiting

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem · Phase 1, PHASE2 · not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and · Phase 1 · not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che · Phase 2 · not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca · Phase 2 · not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar · Phase 1 · 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 NCT03524170 (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 M.D. Anderson Cancer Center
Last refreshed: 7 March 2022

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/NCT03524170.

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