TQB2930 plus chemotherapy for HER2-positive advanced breast cancer

A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer

This study tests whether TQB2930 with chemotherapy works better than trastuzumab with chemotherapy for people with HER2-positive advanced breast cancer who have already had at least two anti-HER2 treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone, trastuzumab
• Locations: 69 sites (Bengbu, Anhui and 68 other locations)
• Trial ID: NCT07047365 on ClinicalTrials.gov

What this trial studies

This Phase 3, randomized, open-label, multicenter trial compares TQB2930 plus an investigator-selected chemotherapy regimen to trastuzumab plus investigator-selected chemotherapy in adults with HER2-positive recurrent or metastatic breast cancer. Participants must have received two or more prior lines of anti-HER2 therapy and have at least one measurable lesion per RECIST 1.1 (excluding brain lesions). The trial will track clinical outcomes such as tumor response, progression, and safety/tolerability across the two treatment arms. Sites for this protocol are regional hospitals in Anhui province, China, and participants must be willing to follow the assigned chemotherapy regimen.

Who should consider this trial

Good fit: Adults aged 18–75 with HER2-positive recurrent or metastatic breast cancer, ECOG performance status 0–1, at least one measurable lesion, adequate organ function, and who have received two or more prior anti-HER2 treatments.

Not a fit: Patients with poor performance status (ECOG >1), uncontrolled comorbidities, brain-only measurable disease, or who cannot receive the investigator-selected chemotherapy regimens are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, TQB2930 could provide an additional effective treatment option that prolongs disease control for patients who have progressed after multiple HER2-directed therapies.

How similar studies have performed: HER2-targeted therapies including newer antibody–drug conjugates have shown clear benefit in later-line disease, and bispecific HER2 antibodies are an emerging approach with encouraging early-phase results but limited phase 3 evidence to date.

Eligibility criteria

Inclusion Criteria:

* Subjects voluntarily participate in this study and sign the informed consent form;
* Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy \>3 months;
* Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;
* Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;
* At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);
* Willing to receive one of the investigator-selected chemotherapy regimens;
* Adequate organ function;
* Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.

Exclusion Criteria:

* Concurrent Diseases and Medical History:

  * Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);
  * Uncontrolled toxicities (\>CTCAE Grade 1) from prior therapies (excluding alopecia);
  * Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;
  * Non-healing wounds or fractures;
  * Arterial/venous thromboembolic events within 6 months before randomization;
  * History of drug abuse or psychiatric disorders that may affect compliance;
  * Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) \>160 mmHg despite treatment);
  * ≥Grade 2 myocardial ischemia/infarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);
  * Active or uncontrolled severe infections (≥CTCAE Grade 2);
  * Known chronic hepatitis B;
  * Active syphilis infection;
  * Renal failure requiring hemodialysis/peritoneal dialysis;
  * Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;
  * Poorly controlled diabetes;
  * Urine protein ≥++ on dipstick with 24-hour urine protein \>1.0 g;
  * Epilepsy requiring medication.
* Tumor-Related Conditions and Treatments:

  * Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization (or within 5 half-lives of prior drugs, whichever is shorter);
  * Chinese herbal medicines with approved antitumor indications (per National Medical Products Administration (NMPA) labeling) within 2 weeks;
  * Severe Bone Lesions from bone metastases;
  * Untreated brain metastases, Leptomeningeal metastases, or carcinomatous meningitis;
  * Prior HER2-targeted therapy-induced Left Ventricular Ejection Fraction (LVEF) decline to \<50% or absolute reduction \>15%;
  * Uncontrolled or symptomatic Hypertension requiring ongoing bisphosphonates;
  * Uncontrolled cancer-related pain;
  * Existed Lymphangitis Carcinomatosa or uncontrolled effusions;
  * Use of Immunosuppressant or systemic corticosteroids (≥10 mg/day prednisone equivalent) within 2 weeks.
* Severe hypersensitivity to monoclonal antibodies;
* Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;
* Any condition deemed by the investigator to jeopardize subject safety or study completion.

Where this trial is running

Bengbu, Anhui and 68 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (Not_yet_recruiting)
• Anhui Provincial Hospital( The First Affiliated Hospital of USTC) — Hefei, Anhui, China (Not_yet_recruiting)
• The Second Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Not_yet_recruiting)
• Chong Qing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Fuzhou First Generel Hospital Affiliated with Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Gansu Cancer Hospital — Lanzhou, Gansu, China (Not_yet_recruiting)
• Sun Yat - sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• Affiliated Cancer Hospital of Guangxi Medical Universit — Nanning, Guangxi, China (Not_yet_recruiting)
• The Affiiated Cancer Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Hainan General Hospital — Haikou, Hainan, China (Not_yet_recruiting)
• The First Hospital of Qinhuangdao — Qinhuangdao, Hebei, China (Not_yet_recruiting)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Tangshan People's Hospital — Tangshan, Hebei, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Not_yet_recruiting)
• Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) — Jiamusi, Heilongjiang, China (Not_yet_recruiting)
• Mudanjiang Cancer Hospital — Mudanjiang, Heilongjiang, China (Not_yet_recruiting)
• AnYang Tumor Hospital — Anyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (Not_yet_recruiting)
• Nanyang Second General Hospital — Nanyang, Henan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Not_yet_recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Jingmen People's Hospital — Jingmen, Hubei, China (Not_yet_recruiting)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (Not_yet_recruiting)
• The First People's Hospital of Changde City — Changde, Hunan, China (Not_yet_recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Not_yet_recruiting)
• People's Hospital of Hunan Province — Changsha, Hunan, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China (Not_yet_recruiting)
• Zhangjiajie People's Hospital — Zhangjiajie, Hunan, China (Not_yet_recruiting)
• JiangSu Cancer Hosipital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Sir Run Run Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Zhangjiagang First People's Hospital — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Xuzhou Central Hospital — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Ganzhou Cancer Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• Jilin Cancer Hospital — Changchun, Jilin, China (Not_yet_recruiting)
• The first hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Affiliated Zhongshan Hospital Of Dalian University — Dalian, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Not_yet_recruiting)
• People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China (Not_yet_recruiting)
• Qinghai University Affiliated Hospital — Xining, Qinghai, China (Not_yet_recruiting)
• Bao Ji Central Hospital — Baoji, Shaanxi, China (Not_yet_recruiting)
• 3201 Hospital — Hanzhong, Shaanxi, China (Not_yet_recruiting)
• The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital) — Xi'an, Shaanxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Qingyuan Zhang, Doctor

Conditions HER2-positive Advanced Breast Cancer