A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

Recruiting now · Phase 3

Conditions studied: HER2-positive Breast Cancer

In brief

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.

Key facts

Study ID

NCT07673029

Run by

GeneQuantum Healthcare (Suzhou) Co., Ltd.

People needed

228

Starts

2025-01-10

Expected to finish

2028-01-09

Last updated by the study team

2026-06-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• The Affiliated Fuyang Hospital of Anhui Medical University — Fuyang, Anhui, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Anhui Cancer Hospital — Hefei, Anhui, China (enrolling)
• The Fifth Medical Center of the Chinese People's Liberation Army General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• The Second Affiliated Hospital of Fujian Medical University — Quanzhou, Fujian, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Meizhou People's Hospital — Meizhou, Guangdong, China (enrolling)
• Shantou Central Hospital — Shantou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (enrolling)
• Guizhou Medical University Cancer Hospital — Guiyang, Guizhou, China (enrolling)
• The Affiliated Hospital of Hebei University — Baoding, Hebei, China (enrolling)
• The Affiliated Hospital of Hebei University of Engineering — Handan, Hebei, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Xingtai People's Hospital — Xingtai, Hebei, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Anyang Cancer Hospital — Anyang, Henan, China (enrolling)
• Luoyang Central Hospital — Luoyang, Henan, China (enrolling)
• The First Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (enrolling)
• The First Affiliated Hospital of Henan Medical University — Xinxiang, Henan, China (enrolling)
• Xuchang Central Hospital — Xuchang, Henan, China (enrolling)
• The First Affiliated Hospital of Bengbu Medical University — Bengbu, Anhui, China (enrolling)

Full record on ClinicalTrials.gov

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