# TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail

> **NCT05375461** · PHASE3 · COMPLETED · sponsor: **Chia Tai Tianqing Pharmaceutical Group Co., Ltd.** · enrollment: 293 (actual)

## Conditions studied

- HR-positive,HER2-negative in Advanced Breast Cancer

## Interventions

- **DRUG:** TQB3616 capsules
- **DRUG:** TQB3616-matching placebo
- **DRUG:** Fluvestrin injection

## Key facts

- **NCT ID:** NCT05375461
- **Lead sponsor:** Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-03-18
- **Primary completion:** 2024-01-16
- **Final completion:** 2025-12-09
- **Target enrollment:** 293 (ACTUAL)
- **Last updated:** 2026-04-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05375461

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05375461, "TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT05375461. Licensed CC0.

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