GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic 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 is a Phase 3, multicenter, open-label, randomized study comparing GQ1005 to T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer who have previously received trastuzumab and taxane. About 228 patients will be randomized 1:1 to receive either GQ1005 or T-DM1. The trial aims to assess efficacy and safety of the two treatments, using RECIST v1.1 for measurable disease and standard clinical criteria. Eligible participants include adults with ECOG 0-1 and at least one measurable lesion, with an expected survival of 12 weeks or more. Key exclusions include prior anti-HER2 ADC therapy and certain lung, allergic, or concurrent cancer conditions.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Bengbu Medical University
  Bengbu, Anhui, China Recruiting
• The Affiliated Fuyang Hospital of Anhui Medical University
  Fuyang, Anhui, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, Anhui, China Recruiting
• Anhui Cancer Hospital
  Hefei, Anhui, China Recruiting
• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Zefei Jiang, M.D. — The Fifth Medical Center of the Chinese People's Liberation Army General Hospital
• Study coordinator: Zhenxing Yang
• Email: yangzx@genequantum.com
• Phone: +86 13801896162

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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.