phase ii pilot study assessing efficacy of a cisplatin - métronomic cyclophosphamide treatment in patients with stade iv triple negative breast cancer secondary resistant to anthracyclines and taxanes

Conditions: Metastatic Breast Cancer

Summary: study assessing efficacy of a cisplatine- métronomic cyclophosphamide treatment in patients with metastatic triple negative breast cancer secondary resistant to anthracyclines and taxanes.


Eligibility criteria:
inclusion criteria: * performance status \< 2, * patient with metastatic breast cancer stade iv triple negative histologically confirmed * measurable or not disease but radiologically evaluable (recist 1.1), * negative hormonal receptors (estrogens and/or progesterone), * her-2 negative (score 0 or 1 by immunochemistry (ihc), negative fish if score ihc 2), * patient exposed to anthracyclines and/or taxanes in neo-adjuvant or adjuvant setting, * patient with a progression and for whom anthracyclines and/or taxanes treatment cannot be delivered and according to a resistance defined as : * in the last 12 months after the last dose of taxanes or anthracyclines in adjuvant or neoadjuvant setting or, * during or after a first metastatic chemtotherapy line and where taxanes and anthracyclines cannot be delivered according to : * either a secondary resistance after an initial response to chemotherapy but a relapse observed either during the treatment or in the 4 months after the end of chemotherapy. * either a sensitivity to treatment defined by a relapse after more than 4 months after the first chemotherapy metastatic line, * either intolerance to anthracyclines (doxorubicin 240-400 mg/m² ou equivalent to doxorubicin (epirubicin) 300-550mg/m²) * patient non previously treated by platinum salts, * hematological functions: neutrophiles ≥ 1,5.109/l, platelets ≥ 100.109/l, leucocytes \> 3 000/mm3, hb \> 9g/dl, hepatic functions : total bilirubin ≤ 1,5 time upper normal value (unv), asat ≤ 2 ,5 time unv, alat ≤ 2,5 time unv, alkaline phosphatase ≤ 2,5 time unv (\ 1,5 time unv, so clearance ≥ 60 ml/min) or clearance ≥ 40 ml/min in case of rmi, * patient signed the consent study form, * patient affiliated to a social security regimen (law of 9 august 2004). exclusion criteria: * male patients, * unknown hormonal receptors * positive her-2 (score 3 in ihc or positive fish) * pregnant or breastfeeding patient, or in age of pregnancy or predicting to be pregnant in the 6 months after the end of treatment, * patient not using contraceptive treatment during the treatment or after the 6 months after the end of treatment, * patient is a ward, * patient suffering from a non compatible disease with the enrollment in the study, * cardiac, renal, medullar, respiratory or hepatic insufficiency, clinically significant cardiovascular disease (including myocardiac infarct, unstable angina, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia) \< 1 year before the study enrollment or randomisation, * patient with pulmonary lymphangitis or symptomatic pleural effusion (grade≥2), meningeal known carcinoma or symptoms of cerebromeningeal invasion, brain metastases unless treatment and stability for at least 4 weeks (no steroids or anti-convulsive). * uncontrolled diabetes, * psychiatric or neurological significant abnormality, * peripheric neuropathy \> grade 2, * antecedent of hypersensibility to one of study treatment or one of used excipients, * urinary tract infection or acute hemorrhagic cystitis in progress * concomitant treatment with a medicine containing phenytoin or medication received in the context of a trial, or participation in another therapeutic clinical trial within \<30 days prior treatment with chemotherapy. * geographically unstable patient in the next 6 months or remaining distance to the treatment center making it difficult to follow in the study, * known history of abuse of narcotic or other drug or alcohol * history of surgery within 28 days before the start of treatment, * patient unwilling or unable to comply with the requirements of the study.

Keywords: triple negative breast cancer late-relapse