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

Phase 2

Terminated

• Conditions: Metastatic Breast Cancer
• Interventions: Drug: Cisplatin; Drug: Cyclophosphamide

• Registration Number: NCT01910844
• Lead Sponsor: Centre Jean Perrin

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-28
• Study Start: 2013-07
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-30
• Status Verified: 2016-07
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cisplatin - Metronomic Cyclophosphamide	Cisplatin	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
Cisplatin - Metronomic Cyclophosphamide	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

Primary Outcome Measures

Name	Time	Method
Response rate of cisplatine - metronomic cyclophosphamide treatment	12 months and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Predictive factors to response and/or resistance treatment	12 months and 6 weeks
Disease free progression	3 years
Safety profile of cisplatin - metronomic cyclophosphamide association	12 months and 6 weeks	Number of Participants with Adverse Events
Overall survival	5 years

Trial Locations

Locations (1)

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France