EUCTR2010-019752-50-BE进行中（未招募）1 期
A multicenter, multinational phase II study to assess the clinical safety and feasibility of T-DM1 sequentially with anthracyline-based chemotherapy, as adjuvant or neoadjuvant therapy for patients with early stage HER2-positive breast cancer.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with locally advanced, inflammatory, or early stage, unilateral, and histologically confirmed invasive breast cancer documented at a local laboratory. Patients with inflammatory breast cancer must be able to have a core needle biopsy.
- •HER2-positive tumor, confirmed by central testing
- •Willingness to receive anthracycline-based chemotherapy or have received doxorubicin/cyclophosphamide (AC) OR 5-FU/epirubicin/cyclophosphamide (FEC) in a similar dose and schedule as described in the protocol as part of neoadjuvant or adjuvant treatment
- •For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 3 months after the last dose of study treatment. Male patients should use condoms for the duration of the study. Specific country requirements will be followed.
- •Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause
- •Patients may enroll before or after AC/FEC chemotherapy has completed.
- •Written, informed consent
- •Eastern Cooperative Oncology Group performance status of 0 or 1
- •Adequate hematologic, biochemistry and cardiac assessments.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Stage IV breast cancer or bilateral breast cancer
- •Pregnant or breastfeeding women
- •History of other malignancy within the previous 5 years, except contralateral breast cancer and ductal carcinoma in situ (DCIS)/lobular carcinoma in situ, appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with outcome similar to those mentioned above
- •Radiation therapy, immunotherapy, or biotherapy within 5 years before study enrollment; non-cardiotoxic chemotherapy for malignancy treated > 5 years before study enrollment is allowed. Patients receiving AC/FEC in a similar fashion to the study treatment prescribed for adjuvant or neoadjuvant treatment of breast cancer will be allowed to enroll in the study after the completion of their AC/FEC. No other prior history of cardiotoxic chemotherapy is allowed.
- •Concurrent medical conditions, which, in the judgment of the investigator, would make them inappropriate candidates for study enrollment; this includes patients with known infection with HIV, HBV, or HCV.
- •Active cardiac history
- •Current chronic daily treatment with oral corticosteroids or equivalent
- •Patients with severe dyspnea at rest or requiring supplementary oxygen therapy
- •Active, unresolved infections at screening
- •Major surgery within 4 weeks before enrollment that is unrelated to the breast cancer
- •Patients for whom concomitant radiotherapy + T-DM1 may be contraindicated yet radiation therapy is planned
- •Known hypersensitivity to any of the study drugs or derivatives, including murine proteins
- •Grade ≥ 2 peripheral neuropathy at baseline.
研究者
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