Metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: Pertuzumab
Product Code: RO4368451
Pharmaceutical Form: Concentrate for solution for infusion
Current Sponsor code: RO4368451
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed breast cancer. 2. HER2-positive tumors. HER2 status must be re-confirmed in a central lab before study entry. 3. Availability of a FFPE tumor tissue sample from primary tumor for eligibility (HER2-status) testing and biomarker assessment 4. Patients with metastatic breast cancer, who have progressed on Herceptin-based therapy as last treatment for metastatic disease. 5. Patients with = 3 chemotherapy regimens prior to study entry. 6. The last dose of Herceptin must have been given = 9 weeks prior to study day 1. 7. At least one measurable lesion according to RECIST. A measurable lesion in a previously irradiated area has to reveal clear signs of progression (increase in size of = 50% or new lesions) 8. At least 4 weeks since prior radiotherapy, with full recovery. 9. At least 4 weeks since major surgery, with full recovery. 10. LVEF of = 55 % or local parameter for = LLN by echocardiography or MUGA. 11. Performance status ECOG = 2. 12. Age = 18 years 13. 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. Prior treatment with any targeted therapy other than Herceptin, such as cetuximab, bevacizumab, gefitinib or with anticancer vaccine. 2. Prior exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicine > 360 mg/m2, epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2 3. Known asymptomatic decreases in LVEF to below 50% absolute value during Herceptin treatment. 4. Patients with known history of any cardiac adverse event which according to the criteria of the investigator was related to Herceptin therapy. 5. History of congestive heart failure (any NYHA grading), unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease. 6. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma 7. Absolute Neutrophil Count (ANC) 1.5 x ULN, AST, ALT > 2.5 x ULN, (> 5 x ULN in patients with liver metastases). 9. Serum creatinine > 2 x ULN 10. History or clinical evidence of brain metastases. 11. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture). 12. Patients with severe dyspnea at rest requiring supplementary oxygen therapy due to complications of advanced malignancy. 13. Positive serum pregnancy test in women of childbearing potential. 14. Patients with reproductive potential not willing to use effective method of contraception. 15. Pregnant or lactating women. 16. Patients with known infection with HIV, HBV, HCV. 17 Known hypersensitivity to Herceptin, murine proteins, or to any of its excipients. 18. Treatment with any investigational drug within 28 days prior to the start of the study. 19. Patients assessed by the investigators 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 efficacy of pertuzumab in combination with Herceptin® in patients who have progressed on Herceptin®-based therapy as determined by the objective response rate and/or the clinical benefit response rate (total of the number of responses and the number > 6 month stable diseases).; Secondary Objective: •To assess the safety profile of the combination of pertuzuamb and Herceptin®. •To determine the duration of response, time to response, time to progression, progression-free survival and overall survival. •To evaluate biomarkers that may be associated with clinical benefit due to pertuzumab in combination with Herceptin®. ; Primary end point(s): Objective Response (OR): Objective response by tumor measurement according to RECIST criteria has occurred if there is documented and confirmed Complete Response (CR) or Partial Response (PR). Clinical Benefit Response (CBR): includes patients who have met the criteria for objective response at any time and for any duration (minimum of 4 weeks) and patients whose best response was stable disease (defined according to RECIST criteria) that lasted at least 6 months (or 8 cycles of therapy). Both OR and CBR are based on evaluations of target and non-target lesions to ascertain the overall best response status of each patient. | — |
Countries
Italy, Spain, United Kingdom
Outcome results
None listed