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

Centre Jean Perrin

Status and phase

Terminated

Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: Metronomic Cyclophosphamide

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01910870

META1 - CJP4.1

Details and patient eligibility

About

To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.