Phase II Pilot Study Assessing Efficacy of a Cisplatin - Metronomic Cyclophosphamide Treatment in Patients With Metastatic Triple Negative Breast Cancer Resistant to Anthracyclines and Taxanes
Phase 2
Terminated
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT01910870
- Lead Sponsor
- Centre Jean Perrin
- Brief Summary
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
Inclusion Criteria
- Age > 18 ans,
- 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 with a progression during or after an anthracyclines and/or taxanes treatment receiving in neo-adjuvant or adjuvant regimen according to a resistance defined as a documented disease progression in the last 12 month after the last dose of taxanes or anthracyclines,
- 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: Creatinine Clearance ≥ 60 mL/min,
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cisplatin - Metronomic Cyclophosphamide Metronomic Cyclophosphamide Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks Cisplatin - Metronomic Cyclophosphamide Cisplatin Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks
- Primary Outcome Measures
Name Time Method Response rate of cisplatin - metronomic cyclophosphamide treatment 18 months and 6 weeks
- Secondary Outcome Measures
Name Time Method Predictive factors to response and/or resistance treatment 18 months and 6 weeks Disease free progression 3 years safety profile of cisplatin - metronomic cyclophosphamide association 18 months and 6 weeks Number of Participants with Adverse Events
Overall survival 5 years
Trial Locations
- Locations (1)
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France