# To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer

Source: https://onco.cc/trials/nct05365178/  
OnCo record `nct05365178` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.

## Summary

To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT05365178, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer. Planned enrolment is 432 participants (actual). The study started in 2022-07-01 and primary completion is expected in 2025-07-02. No results have been posted on ClinicalTrials.gov.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-11
- Tags: ctgov-ingest
- Registry id: NCT05365178
- Phase: 3
- Setting: A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer
- Sponsor: Chia Tai Tianqing Pharmaceutical
- Enrolled: 432

## Sources

- ClinicalTrials.gov NCT05365178: https://clinicaltrials.gov/study/NCT05365178

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [TQB3616](https://onco.cc/drugs/tqb3616/)
- companies: [Sino Biopharmaceutical (Chia Tai Tianqing)](https://onco.cc/companies/sino-biopharm/)

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