NCT07102381招募中2 期
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 125
- 试验地点
- 56
- 主要终点
- Number of participants with pCR
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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
- •Adequate organ function
- •Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.
- •Adequate contraceptive precautions
- •Participants with known HIV are eligible unless:
- •CD4+ T Cell count is less than or equal to 350 microliters (uL)
- •Detectable viral load, or
- •Receiving protease inhibitors or cobicistat
排除标准
- •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. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.
- •Was treated with surgery, 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
研究组 & 干预措施
Trastuzumab and pertuzumab with docetaxel and carboplatin
Active Comparator
Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
干预措施: Carboplatin (Drug)
Zanidatamab with paclitaxel
Active Comparator
Zanidatamab in combination with chemotherapy paclitaxel
干预措施: Zanidatamab (Drug)
Zanidatamab with paclitaxel
Active Comparator
Zanidatamab in combination with chemotherapy paclitaxel
干预措施: Paclitaxel (Drug)
Trastuzumab and pertuzumab with docetaxel and carboplatin
Active Comparator
Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
干预措施: Trastuzumab (Drug)
Trastuzumab and pertuzumab with docetaxel and carboplatin
Active Comparator
Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
干预措施: Docetaxel (Drug)
Zanidatamab with docetaxel and carboplatin
Active Comparator
Zanidatamab in combination with chemotherapy docetaxel and carboplatin
干预措施: Zanidatamab (Drug)
Zanidatamab with docetaxel and carboplatin
Active Comparator
Zanidatamab in combination with chemotherapy docetaxel and carboplatin
干预措施: Docetaxel (Drug)
Trastuzumab and pertuzumab with docetaxel and carboplatin
Active Comparator
Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin
干预措施: Pertuzumab (Drug)
Zanidatamab with docetaxel and carboplatin
Active Comparator
Zanidatamab in combination with chemotherapy docetaxel and carboplatin
干预措施: Carboplatin (Drug)
结局指标
主要结局
Number of participants with pCR
时间窗: 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
次要结局
- Number of Participants Discontinuing Study Treatment Due to TEAEs(Up to 23 months)
- 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 that completed breast conservation surgery (BCS)(Up to 8 months)
- Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE)(Up to 23 months)
- Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library(Up to 23 months)
- Overall Survival (OS)(Up to 46 months)
- 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)
- Serum Concentrations of Zanidatamab(Up to 18 months)
- Event Free Survival (EFS)(Up to 46 months)
研究者
研究点 (56)
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