Randomized Phase II Study of the Combination of Gemcitabine (Gemzar) Plus Cisplatin Single Dose Versus Split Dose in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer After Failure of Anthracyclines an/or Taxanes
- Histological or cytological diagnosis of breast carcinoma with evidence of
unresectable, locally recurrent, or metastatic disease. Lesions should not be
amenable to surgery or radiation of curative intent.
- Presence of metastatic or local-regional recurrent disease, according to the American
Joint Committee on Cancer
- Uni-dimensionally measurable lesions with clearly defined margin that are clearly
measurable by following methods according to computerized tomography (CT), Chest
x-ray or clinical examination, according to RECIST criteria
- Patients with unresectable, locally recurrent or metastatic breast cancer who, were
pre-treated with anthracyclines with/without taxanes (paclitaxel,
docetaxel)containing chemotherapy either in neoadjuvant/adjuvant or 1st line
metastatic setting will be enrolled into the study. Prior chemotherapy has to be
terminated 4 weeks prior. Study randomization and disease progression under this
therapy has to be documented, also patients must have completely recovered from all
acute chemotherapy related toxicities (with exception of alopecia).
Prior radiotherapy must be completed at least 30 days before study entry. Patients must
have recovered from the acute toxic effects of the treatment prior to study enrollment
(except for alopecia). Lesions that have been radiated cannot be included as sites of
measurable disease unless clear tumor progression has been documented in these lesions
since the end of radiation therapy.
- Have received treatment within the last 30 days with an investigational drug for any
indication before study entry.
- Concurrent administration of other tumor therapy, including cytotoxic chemotherapy,
surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including
- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy, unless adequately treated.
- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the
- Second primary malignancy that is clinically detectable at the time of consideration
for study enrollment(except in situ carcinoma of cervix or adequately treated basal
cell carcinoma of skin)