HB1801 Combined Treatment of HER2-positive Breast Cancer
ConditionHER2-positive Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About this trial
This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.
Eligibility criteria
Qualifiers
Voluntarily participate in this study and sign the Informed Consent Form (ICF);
Age ≥ 18 years;
Histologically and/or cytologically confirmed unresectable locally recurrent or metastatic breast cancer;
HER2-positive (IHC 3+, or IHC 2+ with ISH-positive);
Disqualifiers
Contraindications to trastuzumab, pertuzumab, or docetaxel, or deemed by the investigator as unsuitable for treatment with HB1801, docetaxel, pertuzumab, or trastuzumab;
Participants with ≥ Grade 3 peripheral neuropathy at randomization;
Toxicities from prior anticancer therapy have not resolved to ≤ Grade 1 per CTCAE v5.0 (except for alopecia, peripheral neuropathy, or laboratory abnormalities deemed non-risky by the investigator, which must be ≤ Grade 2);
History of LVEF decline to < 50%, symptomatic congestive heart failure (CHF), or toxicity leading to permanent discontinuation during prior HER2-targeted therapy;
Trial design
Treatments tested in this trial
- HB1801
- Trastuzumab
- Pertuzumab
- Docetaxel
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov