TQB2930 plus chemotherapy for HER2-positive advanced breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• 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
• The Fifth Medical Center of Chinese People's Liberation Army General Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Chong Qing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Not yet recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Qingyuan Zhang, Doctor
• Email: ns86298333@163.com
• Phone: 13313612989

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Auricular point stimulation with dexamethasone versus standard antiemetics for nausea from trastuzumab deruxtecan

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.