A randomized, double-blind, placebo-controlled Phase III trial is assessing the efficacy and safety of TQB3616 capsules combined with standard endocrine therapy in approximately 1,946 women with HR-positive, HER2-negative breast cancer in the adjuvant setting. The trial, sponsored by Chia Tai Tianqing Pharmaceutical Group, is currently active but no longer enrolling.
A multicenter Phase III trial (NCT05780567) is underway to determine whether adding TQB3616—an investigational oral capsule—to standard adjuvant endocrine therapy improves outcomes over endocrine therapy alone in women with hormone receptor (HR)-positive, HER2-negative breast cancer. The trial employs a 2:1 randomization scheme, allocating approximately 1,297 participants to the TQB3616 combination arm and 649 to the placebo-plus-endocrine comparator arm.
Endocrine backbone agents permitted in both arms include the aromatase inhibitors letrozole and anastrozole, as well as the selective estrogen receptor modulator tamoxifen, reflecting standard-of-care options across pre- and postmenopausal populations. This design allows assessment of TQB3616's additive benefit regardless of the specific endocrine agent used, broadening the potential generalizability of findings.
TQB3616 is a CDK4/6 inhibitor in clinical development by Chia Tai Tianqing Pharmaceutical Group. Its evaluation in the adjuvant HR+/HER2− setting follows the established precedent of CDK4/6 inhibitors demonstrating invasive disease-free survival benefit in this population. The trial is currently active but has closed to new enrollment; efficacy and safety data are anticipated in future reporting.
Key points
- Phase III, randomized, double-blind trial evaluating TQB3616 capsules added to adjuvant endocrine therapy versus placebo plus endocrine therapy in HR+/HER2− breast cancer
- Approximately 1,946 female participants enrolled in a 2:1 ratio (TQB3616 arm: ~1,297; placebo arm: ~649)
- Permitted endocrine backbone agents include letrozole, anastrozole, and tamoxifen
- TQB3616 is a CDK4/6 inhibitor under development by Chia Tai Tianqing Pharmaceutical Group
- Trial status is active but no longer recruiting; primary efficacy and safety results are pending
Why it matters
CDK4/6 inhibition in the adjuvant HR+/HER2− breast cancer setting remains an area of active investigation, with approved agents demonstrating meaningful reductions in disease recurrence. Results from this trial will clarify whether TQB3616 offers a comparable or differentiated benefit profile within this therapeutic class.