Clinical trial NCT01910870: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Early-relapse
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.


Eligibility criteria: 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.

Primary outcomes:
measure: Response rate of cisplatin - metronomic cyclophosphamide treatment
timeFrame: 18 months and 6 weeks
Secondary outcomes:
measure: Disease free progression
timeFrame: 3 years
measure: safety profile of cisplatin - metronomic cyclophosphamide association
timeFrame: 18 months and 6 weeks
measure: Overall survival
timeFrame: 5 years
measure: Predictive factors to response and/or resistance treatment
timeFrame: 18 months and 6 weeks
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
Study officials:
affiliation: Centre Jean Perrin
name: Marie-Ange MOURET-REYNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: