Locally advanced, inflammatory or early stage HER2-positive breast cancer. MedDRA version: 12.0 Level: LLT Classification code 10065430 Term: HER-2 positive breast cancer
Conditions
Interventions
Product Name: Pertuzumab
Product Code: RO4368451/F01
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Pertuzumab
CAS Number: 380610-27-5
Current Sponsor code: RO 4368451
Sponsors
F. Hoffmann - La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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) 1.25 x ULN (with the exception of Gilberts syndrome), AST, ALT > 1.25 x ULN, albumin 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To make a preliminary assessment of the tolerability of neoadjuvant treatment with one of the following treatment regimens: FEC->T with trastuzumab and pertuzumab given from the start of the chemotherapy regimen (i.e. concurrently with the anthracycline). (Arm A). OR FEC ->T with trastuzumab and pertuzumab given from the start of the taxane treatment (i.e. sequentially with the anthracycline). (Arm B). OR TCH with pertuzumab, with both antibodies being given from the start of the chemotherapy. (Arm C).;Secondary Objective: To make a preliminary assessment of the activity associated with each regimen as indicated by the pathological complete response (pCR) rate. To evaluate the safety profiles of each treatment regimen, including pre-operative (neoadjuvant) and post-operative (adjuvant) treatment. To investigate the overall survival, the time to clinical response, time-to-response, disease free survival and progression free survival for each treatment arm. To investigate the biomarkers that may be associated with primary and secondary efficacy endpoints in accordance with each treatment arm. To investigate the rate of breast conservative surgery for all patients with T2-3 tumors for whom mastectomy was planned at diagnosis. An overall assessment of the risk and benefit of each regimen will be made.;Primary end point(s): The primary objective of the study is to describe the tolerability of the treatment regimens in Arms A, B and C during neoadjuvant treatment. The primary endpoint of this study therefore does not relate to efficacy. The following safety endpoints are considered of primary importance for the evaluation of the primary objective: Incidence of symptomatic cardiac events as assessed by the Investigator (Grade 3, 4 or 5 symptomatic LVSD) LVEF measures over the course of the neoadjuvant period (LVEF decline of &#8805; 10% from baseline and to a value of <50% ). | — |
Countries
Germany, Greece, Italy, Portugal, Sweden, United Kingdom
Outcome results
None listed