NCT04296370

A Study of Fluzoparib±Apatinib Versus Chemotherapy Treatment of Physician's Choice in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation

Status unknown Phase 3 Last updated 10 August 2020

What this trial tests

Phase 3 trial testing Fluzoparib; Apatinib in Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation in 474 participants. Status unknown.

Timeline

13 July 2020

Primary endpoint
30 June 2022

30 June 2025

Quick facts

Lead sponsor	Jiangsu HengRui Medicine Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	474
Start date	13 July 2020
Primary completion	30 June 2022
Estimated completion	30 June 2025
Sites	1 location across China

Drugs / interventions tested

• Fluzoparib; Apatinib — full drug profile →
• Fluzoparib — full drug profile →
• Physician's choice chemotherapy — full drug profile →

Conditions studied

• Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation — all drugs for Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation →

Sponsor

Jiangsu HengRui Medicine Co., Ltd. — full company profile →

Who can join

Adults 18 to 70, female only, with Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Physicians Choice Chemotherapy, as treatment, in patients with a Germline BRCA Mutation and HER2-negative Metastatic Breast Cancer. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Publications & conference data

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

1. BRCA1 and Breast Cancer: Molecular Mechanisms and Therapeutic Strategies.
   Fu X, Tan W, Song Q, Pei H, et al · · 2022 · cited 77× · PMID 35300412 · DOI 10.3389/fcell.2022.813457
2. Fuzuloparib: First Approval.
   Lee A. · · 2021 · cited 63× · PMID 34118019 · DOI 10.1007/s40265-021-01541-x
3. Targeting DNA repair for cancer treatment: Lessons from PARP inhibitor trials.
   Nambiar DK, Mishra D, Singh RP. · · 2023 · cited 40× · PMID 37415740 · DOI 10.32604/or.2023.028310
4. BRCA Mutations-The Achilles Heel of Breast, Ovarian and Other Epithelial Cancers.
   Loboda AP, Adonin LS, Zvereva SD, Guschin DY, et al · · 2023 · cited 18× · PMID 36902416 · DOI 10.3390/ijms24054982
5. Overview of fuzuloparib in the treatment of ovarian cancer: background and future perspective.
   Li N, Liu Q, Tian Y, Wu L. · · 2022 · cited 13× · PMID 36335989 · DOI 10.3802/jgo.2022.33.e86
6. A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis.
   Liu Y, Wang W, Yin R, Zhang Y, et al · · 2023 · cited 12× · PMID 37775744 · DOI 10.1186/s12916-023-03046-8
7. Therapeutic advances and application of PARP inhibitors in breast cancer.
   Zhou T, Zhang J. · · 2025 · cited 9× · PMID 40359851 · DOI 10.1016/j.tranon.2025.102410
8. Targeting Breast Cancer: The Familiar, the Emerging, and the Uncharted Territories.
   Montazeri Aliabadi H, Manda A, Sidgal R, Chung C. · · 2023 · cited 6× · PMID 37759706 · DOI 10.3390/biom13091306