NCT07673029 A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
| NCT ID | NCT07673029 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GeneQuantum Healthcare (Suzhou) Co., Ltd. |
| Condition | HER2-positive Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2027-01-09 |
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 228 participants in total. It began in 2025-01-10 with a primary completion date of 2027-01-09.
⚠ 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 is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.
Eligibility Criteria
Inclusion Criteria: * Male or female adults ≥ 18 years at the time of voluntary signing of informed consent. * Pathologically confirmed unresectable or metastatic HER2 positive breast cancer previously treated with trastuzumab and taxane * Eastern Cooperative Oncology Group (ECOG) performance status score is 0 or 1. * Presence of at least one measurable lesion according to RECIST v1.1 * Expected survival time ≥ 12 weeks. * Patients must give informed consent to this study and voluntarily sign written informed consent form prior to the study NOTE: Other protocol defined Inclusion/Exclusion criteria may apply. Exclusion Criteria: * Prior anti-HER2 ADC therapy. * Previous history of interstitial lung disease/noninfectious pneumonitis/radiation pneumonitis requiring steroid therapy. * Known serious hypersensitivity to the active ingredients of the study drug, inactive ingredients in the formulation, or other antibody drugs. * Multiple primary malignancies within 3 years, except for adequately resected non-melanoma skin cancer, curatively treated in situ tumor, or contralateral breast cancer * Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled diabetes, hypertension, or other systemic disease that makes compliance with study procedures difficult * Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
Contact & Investigator
Zefei Jiang, M.D.
PRINCIPAL INVESTIGATOR
The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
Frequently Asked Questions
Who can join the NCT07673029 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HER2-positive 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 NCT07673029 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 228 participants.
Is NCT07673029 currently recruiting?
Yes, NCT07673029 is actively recruiting participants. Contact the research team at yangzx@genequantum.com for enrollment information.
Where is the NCT07673029 trial being conducted?
This trial is being conducted at Bengbu, China, Fuyang, China, Hefei, China, Hefei, China and 11 additional locations.
Who is sponsoring the NCT07673029 clinical trial?
NCT07673029 is sponsored by GeneQuantum Healthcare (Suzhou) Co., Ltd.. The principal investigator is Zefei Jiang, M.D. at The Fifth Medical Center of the Chinese People's Liberation Army General Hospital. The trial plans to enroll 228 participants.
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