Study assessing efficacy of a Cisplatine – Métronomic yclophosphamidetreatment in Patients with Metastatic Triple Negative breast CancerSecondary Resistant to Anthracyclines and Taxanes

• Conditions: Triple negative metastatic breast cancer resistant secondary to anthracyclines and taxanes; MedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-005213-39-FR
• Lead Sponsor: CENTRE JEAN PERRI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-16
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Age > 18 ans,
Performance status < 2,
Patient with metastatic breast cancer stade IV triple negative
histologically confirmed
Mesurable 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, Alcaline 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 = 50 mL/min) or Clearance = 40 mL/min in case of RMI,
Patient signed the consent study form,
Patient affilated to a social security regimen (law of 9 August 2004).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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 insuffisancy,
clinically significant cardiovascular disease (including myocardic
infarctus, 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-convulsives).
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 clinical trial of medicinal product
• Study Design: Not specified