Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

May 12, 2019

Primary Completion Date

June 10, 2023

Study Completion Date

December 10, 2025

Conditions
Breast Cancer
Interventions
DRUG

Dalpiciclib

Dalpiciclib (SHR6390) is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.

DRUG

Pyrotinib

Pyrotinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor, showed promising anti-tumour activity and acceptable tolerability in patients with HER2+ metastatic breast cancer (MBC)

DRUG

Letrozole

Letrozole, a third-generation aromatase inhibitor, is the principal drug used in the treatment of postmenopausal patients with both early- and advanced-stage endocrine-responsive breast cancer (BC).

DRUG

Fulvestrant

Fulvestrant is a selective oestrogen receptor (ER) degrader used in postmenopausal women with hormone receptor-positive advanced breast cancer

Trial Locations (1)

200032

Fudan University Shanghai Cancer Center, Shanghai

All Listed Sponsors
collaborator

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

lead

Fudan University

OTHER

NCT03772353 - Pyrotinib, Dalpiciclib(SHR6390) and Endocrine Therapy in Subjects With Dual-receptor Positive(ER+/HER2+) Advanced Breast Cancer | Biotech Hunter | Biotech Hunter