NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 3

Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

Conditions: HER2-positive Breast Cancer

Interventions: GQ1005, T-DM1

Countries: China

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (70)

Bengbu, Anhui, China
Fuyang, Anhui, China
Hefei, Anhui, China
Hefei, Anhui, China
Beijing, Beijing Municipality, China
Chongqing, Chongqing Municipality, China
Fuzhou, Fujian, China
Quanzhou, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Meizhou, Guangdong, China
Shantou, Guangdong, China
Nanning, Guangxi, China
Guiyang, Guizhou, China
Guiyang, Guizhou, China
Baoding, Hebei, China
Handan, Hebei, China
Shijiazhuang, Hebei, China
Xingtai, Hebei, China
Harbin, Heilongjiang, China
Anyang, Henan, China
Luoyang, Henan, China
Luoyang, Henan, China
Xinxiang, Henan, China
Xuchang, Henan, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
+ 40 more on CT.gov