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

Metastatic Breast Cancer Clinical Trial

— META2  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01910844
• Other study ID #: CJP 4.2 - META2
• Status: Terminated
• Phase: Phase 2
• First received: May 28, 2013
• Last updated: October 10, 2016
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: July 2016
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Cisplatin
25 mg/m² I.V. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks
• Cyclophosphamide
Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate of cisplatine - metronomic cyclophosphamide treatment		12 months and 6 weeks	No
Secondary	Disease free progression		3 years	No
Secondary	Safety profile of cisplatin - metronomic cyclophosphamide association	Number of Participants with Adverse Events	12 months and 6 weeks	Yes
Secondary	Overall survival		5 years	No
Secondary	Predictive factors to response and/or resistance treatment		12 months and 6 weeks	No