Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

• Status: Terminated
• Trial end date: 2009-07-25
• Target enrollment: 0
• Participant gender: Female

Summary

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spanish Breast Cancer Research Group
• Collaborator: Hoffmann-La Roche
• Treatments: Capecitabine; Trastuzumab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• Written informed consent.

• Women older than 18 years old.

• HER2 positive breast cancer with histological diagnoses.

• Non-operable locally advanced or metastatic disease, previously treated with trastuzumab and taxanes.

• Measurable or non-measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).

• Disease progression during or after treatment with trastuzumab and taxanes.

• Maximum of 1 previous chemotherapy line for advanced or metastatic disease.

• Previous radiotherapy is allowed if radiated area is not the only documented lesion.

• At least 4 weeks since the last administration of antineoplastic treatment and all toxicities resolved.

• Performance status Eastern Cooperative Oncology Group (ECOG) >=2.

• Life expectancy of at least 12 weeks.

• Left Ventricular Ejection Fraction (LVEF) evaluation (>=50%) in previous 4 weeks.

• Hematology:

• neutrophils >=1.5 x 10e9/l;

• platelets >= 100 x 10e9/l;

• hemoglobin >= 10 mg/dl

• Hepatic function:

• total bilirubin <= 1.5 x under normal limit (UNL);

• Aspartate aminotransferase (SGOT) and Alanine aminotransferase (SGPT) and alkaline phosphatase <= 2.5 x UNL, or <=5 x UNL if hepatic lesions present

• Renal function:

• creatinine <= 175 µmol/l (2 mg/dl);

• creatinine clearance >= 60 ml/min.

• Patients able to comply with treatment and follow-up.

• Negative pregnancy test in the previous 14 days. Adequate contraceptive method during treatment and up to 3 months after finalised.

• Brain metastatic lesions are allowed provided all other criteria are met.

• Male who met inclusion criteria are eligible.

Exclusion Criteria:

• History of hypersensitivity to vinorelbine, trastuzumab, rat proteins or trastuzumab components.

• History of dyspnea at rest, or chronic oxygen therapy required.

• Active infection.

• Second malignancy, except for cervical in situ carcinoma, basal skin carcinoma, adequately treated. Previous malignancies with a 5 year disease free survival are allowed.

• Pregnant or lactating women.

• Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.

• History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.

• Active uncontrolled infection.

• Active peptic ulcer, unstable diabetes mellitus.

• Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.

• Concomitant treatment with other therapy for cancer.