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

TerminatedPhase 2

Sponsor: Spanish Breast Cancer Research Group

Conditions: Breast Cancer

Interventions: Vinorelbine, Capecitabine, Trastuzumab

Countries: Spain

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).

Eligibility overview

Sex: FEMALE

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (1)

San Sebastián de los Reyes, Madrid, Spain