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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Zanidatamab
DrugAdministered intravenously (IV)
Paclitaxel
DrugAdministered intravenously (IV)
Docetaxel
DrugAdministered intravenously (IV)
Carboplatin
DrugAdministered intravenously (IV)
Trastuzumab
DrugAdministered intravenously (IV)
Pertuzumab
DrugAdministered intravenously (IV)
Treatment groups
125 Participants
are divided into 3 treatment groupsGroup A: Zanidatamab with paclitaxelActive comparator 2 interventions
Group B: Zanidatamab with docetaxel and carboplatinActive comparator 3 interventions
Group C: Trastuzumab and pertuzumab with docetaxel and carboplatinActive comparator 4 interventions
Trial outcomes
Primary outcomes
1
Number of participants with pCR
Pathologic complete response (pCR) is defined as lacking all signs of cancer in the tissue samples removed in the breast or axilla (armpit) during surgery or biopsy after study treatment
Time frame
Up to 8 monthsSecondary outcomes
1
Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification
Time frame
Up to 8 months2
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame
Up to 23 months3
Number of Participants Discontinuing Study Treatment Due to TEAEs
Time frame
Up to 23 months4
Number of participants that completed breast conservation surgery (BCS)
Time frame
Up to 8 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jazz Pharmaceuticals
Lead sponsor
Jazz Pharmaceuticals Ireland Limited
Collaborator
Source ClinicalTrials.gov