Metastatic Breast Cancer
Conditions
Keywords
triple negative breast cancer, late-relapse
Brief summary
Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.
Interventions
DRUGCisplatin
25 mg/m² I.V. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks
DRUGCyclophosphamide
Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks
Sponsors
Centre Jean Perrin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 (\< 5 time UNV if case of hepatic metastasis), Renal Functions: Serum Creatinine ≤ 1,5 time UNV (and if value \> 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of cisplatine - metronomic cyclophosphamide treatment | 12 months and 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of cisplatin - metronomic cyclophosphamide association | 12 months and 6 weeks | Number of Participants with Adverse Events |
| Overall survival | 5 years | — |
| Predictive factors to response and/or resistance treatment | 12 months and 6 weeks | — |
| Disease free progression | 3 years | — |
Countries
France
Outcome results
None listed