A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administrationin Participants with Early or Locally Advanced/ Inflammatory HER2-Positive Breast Cancer - MO43110

F. Hoffmann-La Roche AG0 个研究点目标入组 347 人开始时间: 2024年3月26日最近更新: 2024年7月22日

试验速览

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•Eastern Cooperative Oncology Group (ECOG) performance status 0-1, Female and male participants with stage II-IIIC early or locally advanced/inflammatory HER2+ breast cancer, Primary tumor > 2 cm in diameter, or node-positive disease, HER2+ breast cancer confirmed by a local laboratory prior to study enrollment, Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates, Adequate wound healing after breast cancer surgery per investigator’s assessment to allow initiation of study treatment within = 9 weeks of last systemic neoadjuvant therapy

•Stage IV breast cancer, History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years, Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR), Inadequate bone marrow function defined by any of: - Participants who have an absolute neutrophil count (ANC) < 1.5 x 109/L - Platelet count < 100 x 109/L - Hemoglobin < 9 g/dL, Participants who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy [selective estrogen receptor modulators, aromatase inhibitors], and antitumor vaccines for treatment or prevention of breast cancer, or previous chest irradiation radiation therapy for the treatment of cancer, Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer. Participants are allowed to enter the studyif treated with surgery alone

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