Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedSIR
About this trial
The JAZMINE study is a multicenter, open-label, non-comparative, phase Ib/II clinical trial to evaluate safety and preliminary efficacy of zanidatamab in combination with tucatinib and chemotherapy (capecitabine or eribulin mesylate) in HER2-positive advanced breast cancer.
Eligibility criteria
Qualifiers
Participants must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.
Female or male participants ≥ 18 years of age at the time of signing the ICF.
ECOG PS of 0-1.
Minimum life expectancy of ≥ 12 weeks at screening.
Disqualifiers
Participation in another clinical trial, interventional or observational, until the Study's safety visit.
Have received treatment with any systemic anti-cancer therapy (including hormonal therapy), non-CNS radiation, or experimental agent within ≤ 3 weeks prior to the first dose of Study treatments.
Prior treatment with capecitabine and eribulin.
Known or suspected leptomeningeal disease (LMD) as documented by the investigator.
Trial design
Treatments tested in this trial
- Zanidatamab
- Tucatinib
- Capecitabine
- Eribulin Mesilate injection
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov