RecruitingPhase 3NCT07003074

A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer

A Randomized, Open, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2) Positive Recurrent or Metastatic Breast Cancer

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Enrollment

642 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or docetaxel combined with trastuzumab and pertuzumab, respectively.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called TQB2102 to the standard treatment combination (docetaxel, trastuzumab, and pertuzumab) for people with HER2-positive breast cancer that has returned or spread after earlier treatment. **You may be eligible if...** - You are 18–75 years old with HER2-positive invasive breast cancer that has come back or spread - You have not yet received systemic treatment for your metastatic or recurrent disease (only prior endocrine therapy is allowed) - If you had adjuvant (post-surgery) therapy, your cancer returned more than 12 months after treatment ended - You have at least one measurable tumor on imaging - Your major organ function is adequate **You may NOT be eligible if...** - You have known spinal cord compression or active brain metastases - You have had another cancer in the past 5 years - You had major surgery within 4 weeks of starting the study - You have unresolved side effects from prior treatment - 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

DRUGTQB2102 for Injection

TQB2102 is a next-generation HER2 Antibody-Drug Conjugate drug proposed for patients with HER2 positive Recurrent/Metastatic Breast Cancer.

DRUGDocetaxel combined + Trastuzumab +Pertuzumab

Positive control.

Locations(25)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Tiantan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Shantou Central Hospital

Shantou, Guangdong, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

Puyang Oilfield General Hospital

Puyang, Henan, China

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, China

The first hospital of Jilin University

Changchun, Jilin, China

Affiliated Zhongshan Hospital Of Dalian University

Dalian, Liaoning, China

Affiliated Zhongshan Hospital Of Dalian University

Dalian, Liaoning, China

Liaoning Provincial Cancer Hospital

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'An Jiaoting Yniversity

Xi'an, Shaanxi, China

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Fudan University shanghai cancer center

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Yuncheng Central Hospital, Shanxi Province

Yuncheng, Shanxi, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The Affiliated Tumor Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

View Full Details on ClinicalTrials.gov

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NCT07003074

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