Phase II Pilot Study Assessing Efficacy of a Cisplatin - Métronomic Cyclophosphamide Treatment in Patients With Stade IV Triple Negative Breast Cancer Secondary Resistant to Anthracyclines and Taxanes

NCT ID: NCT01910844

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-09-30

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.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cisplatin - Metronomic Cyclophosphamide

Cisplatin 25 mg/m² from day 1 to day 3 every 3 weeks Metronomic Cyclophosphamide 150 mg from day 1 to day 14 every 3 weeks

Group Type: EXPERIMENTAL

Cisplatin

Intervention Type: DRUG

25 mg/m² I.V. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks

Cyclophosphamide

Intervention Type: DRUG

Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks

Interventions

Cisplatin

25 mg/m² I.V. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks

Intervention Type: DRUG

Cyclophosphamide

Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks

Intervention Type: DRUG

Other Intervention Names

Endoxan

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Jean Perrin

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Jean Perrin

Clermont-Ferrand, , France

Countries

France

Other Identifiers

CJP 4.2 - META2

Identifier Type: -

Identifier Source: org_study_id