Status:
TERMINATED
Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief 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 g...
Detailed Description
Principal outcome is clinical benefit (complete + partial responses + stable disease). Sample size in each arm has been estimated with the Fleming method. Previous data show a clinical benefit rate of...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 4 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00130507
Start Date
November 4 2005
End Date
July 25 2009
Last Update
February 26 2019
Active Locations (1)
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1
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700