A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJazz Pharmaceuticals
About this trial
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
Eligibility criteria
Qualifiers
Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.
Has histologically confirmed HER2-positive breast cancer
Has a known hormone receptor (HR) status of the primary tumor
Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
Disqualifiers
Has Stage IV (metastatic) breast cancer.
Has bilateral breast cancer.
Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
Has uncontrolled hypertension
Trial design
Treatments tested in this trial
- Zanidatamab
- Paclitaxel
- Docetaxel
- Carboplatin
- Trastuzumab
- Pertuzumab
Treatment groups
125 Participants
are divided into 3 treatment groupsLocations
30Italy
Ospedale San Raffaele20132, MilanLombardy, Italy
Spain
Hospital Clínico San Cecilio18007, GranadaAndalusia, Spain
Álvaro Cunqueiro Hospital36312, VigoGalicia, Spain
Hospital Universitario Vall d'Hebron0-8035, Barcelona Spain
Sponsors and collaborators
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
Source ClinicalTrials.gov