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.
- Conditions
- Treatment of HER2 positive adjuvant or neoadjuvant therapyMedDRA version: 12.1Level: LLTClassification code 10065430Term: HER-2 positive breast cancer
- Registration Number
- EUCTR2010-019752-50-BE
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 135
• 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method