RecruitingPhase 3NCT05780567

Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy


Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Enrollment

1,946 participants

Start Date

Mar 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding a CDK4/6 inhibitor (TQB3616) to standard hormone therapy helps prevent breast cancer from returning in women with HR-positive, HER2-negative breast cancer after surgery. **You may be eligible if...** - You are 18–75 years old with HR-positive, HER2-negative invasive breast cancer - You have had a radical mastectomy - Your blood counts and organ function meet the required levels - Your heart pumping function (LVEF) is 50% or higher **You may NOT be eligible if...** - You have had another malignancy - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB3616 capsules, Letrozole, Anastrozole, Tamoxifen

TQB3616 is a novel Cyclin-dependent kinase (CDK) 4/6 inhibitor and currently being used in the treatment of a variety of malignant solid tumors. Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.

DRUGPlacebo capsules, Letrozole, Anastrozole, Tamoxifen

Letrozole combined with Anastrozole and Tamoxifen is an endocrine therapy that involves adding, blocking, or removing hormones. It can be used for conditions that affect hormone levels, such as breast cancer.


Locations(3)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Suining Central Hospital

Suining, Sichuan, China

View Full Details on ClinicalTrials.gov

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NCT05780567


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