A randomised, multicentre, multinational Phase II study to evaluate pertuzumab in combination with trastuzumab given either concomitantly or sequentially with standard anthracycline based chemotherapy or concomitantly with a non-anthracycline based chemotherapy regimen, as neoadjuvant therapy for patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. - ND
- Conditions
- ocally advanced, inflammatory or early stage HER2-positive breast cancer.MedDRA version: 12.0Level: LLTClassification code 10065430Term: HER-2 positive breast cancer
- Registration Number
- EUCTR2009-012019-17-IT
- Lead Sponsor
- F. Hoffmann - La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 225
1. Female patients with locally advanced, inflammatory or early stage, unilateral and histologically confirmed invasive breast cancer. Patients with inflammatory breast cancer must be able to have a core needle biopsy. 2. Primary tumor > 2cm in diameter. 3. HER2 positive breast cancer confirmed by a central laboratory. 4. Availability of tumor tissue for central confirmation of HER2 eligibility 5. Female patients, age ≥ 18 years. 6. Baseline LVEF ≥ 55%. 7. Performance status ECOG ≤ 1. 8. At least 4 weeks since major unrelated surgery, with full recovery. 9. A negative pregnancy test must be available for pre-menopausal women and for women less than 12 months after the onset of menopause. 10. For women 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 must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment 11. Signed informed consent.
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
1. Metastatic disease (Stage IV) or bilateral breast cancer. 2. Previous anticancer therapy or radiotherapy for any malignancy. 3. Other malignancy, except for carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. 4. Inadequate bone marrow function (e.g. Absolute Neutrophil Count (ANC) < 1.5 x 109/L, Platelet count < 100 x 109/L and Hb < 9 g/dL). 5. Impaired liver function (e.g. serum [total] bilirubin > 1.25 x ULN (with the exception of Gilberts syndrome), AST, ALT > 1.25 x ULN, albumin < 25 g/L. 6. Inadequate renal function, serum creatinine > 1.5 x ULN.7. Uncontrolled hypertension (systolic > 150 and/or diastolic > 100), unstable angina, CHF of any NYHA classification, serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia), history of myocardial infarction within 6 months of enrollment, or LVEF < 55%. 8. Dyspnea at rest or other diseases which require continuous oxygen therapy. 9. Severe uncontrolled systemic disease. 10. Patients with insulin-dependent diabetes. 11. Pregnant and/or lactating women. 12. Patients with reproductive potential not willing to use a highly effective method of contraception or two effective methods. 13. Received any investigational treatment within 4 weeks of study start. 14. Patients with known infection with HIV, HBV, HCV. 15. Current chronic daily treatment with corticosteroids (dose of >10 mg methylprednisolone, or equivalent [excluding inhaled steroids]) 16. Known hypersensitivity to any of the study drugs or excipients. 17. Patients assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
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