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Compares treatment options for HER2-positive Breast Cancer
Official title A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07673029
What this study is testing
What is GQ1005?
GQ1005 is an investigational medicine, being studied as a potential treatment for her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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.
You likely can't join if
- 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...
- Uncontrolled infection requiring intravenous antibiotics, antiviral or antifungal agents, autoimmune disease requiring treatment, uncontrolled...
See the full eligibility 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/
- 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...
- Unrecovered toxicity from prior anticancer therapy, defined as toxicity (except for alopecia) not recovered to ≤Grade 1 (NCI-CTCAE v5.0) or baseline.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Fuyang, Anhui, China
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Fuzhou, Fujian, China
- Quanzhou, Fujian, China
- Guangzhou, Guangdong, China
- Meizhou, Guangdong, China
- Shantou, Guangdong, China
- Nanning, Guangxi, 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
- Xinxiang, Henan, China
+ 30 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Fuyang, Anhui, China; Hefei, Anhui, China; Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Fuzhou, Fujian, China and 44 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.