NCT07008976 Clinical Trial of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in HER2-positive Advanced Breast Cancer
| NCT ID | NCT07008976 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
| Condition | Metastatic Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 246 participants |
| Start Date | 2025-07-07 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 246 participants in total. It began in 2025-07-07 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
Eligibility Criteria
Inclusion Criteria: * The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance; * Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months; * HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination; * According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive; * The hormone receptor (HR) status has been clearly determined: a) According to the 2020 version of the ASCO/CAP guidelines, HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%. * Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage. * Disease progression occurred during or after the most recent treatment or intolerance. * At least 1 line of treatment has been received in the recurrence/metastasis stage. * According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists. Exclusion Criteria: * Excluded are patients with known spinal cord compression or active central nervous system metastases . * Patients with only skin and/or intracranial lesions as target lesions. * Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1. * Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg). * Patients with major cardiovascular diseases * Patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07008976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07008976 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 246 participants.
Is NCT07008976 currently recruiting?
Yes, NCT07008976 is actively recruiting participants. Contact the research team at szm@163.com for enrollment information.
Where is the NCT07008976 trial being conducted?
This trial is being conducted at Bengbu, China, Hefei, China, Hefei, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07008976 clinical trial?
NCT07008976 is sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. The trial plans to enroll 246 participants.
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