A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
- Conditions
- HER2-positive Breast CancerBreast Cancer
- Interventions
- Registration Number
- NCT07102381
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 125
- Has 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.
- Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function
- Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
- Adequate contraceptive precautions
- 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
- Has significant symptoms from peripheral neuropathy
- Has an active uncontrolled infection
- Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
- Known active hepatitis B or C infection.
- Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
- Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
- Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
- Receipt of a live vaccine within 4 weeks prior to enrollment
- Has a known hypersensitivity to any components of the study interventions, including chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Zanidatamab with paclitaxel Zanidatamab Zanidatamab in combination with chemotherapy paclitaxel Zanidatamab with docetaxel and carboplatin Docetaxel Zanidatamab in combination with chemotherapy docetaxel and carboplatin Zanidatamab with docetaxel and carboplatin Carboplatin Zanidatamab in combination with chemotherapy docetaxel and carboplatin Trastuzumab and pertuzumab with docetaxel and carboplatin Carboplatin Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin Zanidatamab with paclitaxel Paclitaxel Zanidatamab in combination with chemotherapy paclitaxel Trastuzumab and pertuzumab with docetaxel and carboplatin Docetaxel Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin Zanidatamab with docetaxel and carboplatin Zanidatamab Zanidatamab in combination with chemotherapy docetaxel and carboplatin Trastuzumab and pertuzumab with docetaxel and carboplatin Trastuzumab Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin Trastuzumab and pertuzumab with docetaxel and carboplatin Pertuzumab Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
- Primary Outcome Measures
Name Time Method Number of participants with pCR Up to 8 months 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
- Secondary Outcome Measures
Name Time Method Number of Participants Positive for Anti-drug Antibodies to Zanidatamab Up to 18 months Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification Up to 8 months Number of Participants with Treatment-emergent Adverse Events (TEAEs) Up to 23 months Number of Participants Discontinuing Study Treatment Due to TEAEs Up to 23 months Number of participants that completed breast conservation surgery (BCS) Up to 8 months Event Free Survival (EFS) Up to 46 months EFS is defined as the time (in months) from randomization to disease progression, disease recurrence, or death from any cause
Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE) Up to 23 months Symptomatic AEs assessed by the PRO-CTCAE are analyzed at the item level with symptom severity, frequency, and interference scored from 0 to 4 and presence/absence scored 0 to 1, and higher scores reflect worse symptoms.
Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library Up to 23 months Symptomatic AEs assessed by the EORTC Item Library Forms are analyzed at the item level with scores ranging from 1 to 4, where a 4 indicates more severe symptoms.
Overall Survival (OS) Up to 46 months OS is defined as the time in months from randomization to the date of death due to any cause.
Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5) Up to 23 months The Functional Assessment of Chronic Illness Therapy (FACIT) GP5 Item score ranges from 0 (Not at all) to 4 (Very Much), where higher scores reflect greater bother from treatment side effects.
Serum Concentrations of Zanidatamab Up to 18 months
Trial Locations
- Locations (2)
Texas Oncology DFW
🇺🇸Dallas, Texas, United States
Texas Oncology Gulf Coast
🇺🇸Houston, Texas, United States
Texas Oncology DFW🇺🇸Dallas, Texas, United States