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A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.
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.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares TQB3616, Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
Shares Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
Shares Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
Shares Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
Shares Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
Shares Sino Biopharmaceutical (Chia Tai Tianqing), HR-positive / HER2-negative breast cancer.
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