NCT05375461 - TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail | Biotech Hunter

Enrollment

287

Participants

Timeline

Start Date

March 18, 2022

Primary Completion Date

January 16, 2024

Study Completion Date

December 31, 2025

Conditions

HR-positive,HER2-negative in Advanced Breast Cancer

Interventions

DRUG

TQB3616 capsules

The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

DRUG

TQB3616-matching placebo

The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.

DRUG

Fluvestrin injection

Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.

Trial Locations (2)

100039

The Fifth Medical Center of PLA General Hospital, Beijing

100142

Beijing Cancer Hosptital, Beijing