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

NCT01910870 | Terminated Phase 2 DMC

• 1 other identifier: META1 - CJP4.1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

Conditions

Metastatic Breast Cancer

Keywords

Early-relapse

Outcome Measures

Primary Outcomes (1)

• Response rate of cisplatin - metronomic cyclophosphamide treatment

  18 months and 6 weeks

Secondary Outcomes (4)

• Disease free progression

  3 years

• safety profile of cisplatin - metronomic cyclophosphamide association

  18 months and 6 weeks

• Overall survival

  5 years

• Predictive factors to response and/or resistance treatment

  18 months and 6 weeks

Study Arms (1)

Cisplatin - Metronomic Cyclophosphamide

EXPERIMENTAL

Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks

Drug: Cisplatin; Drug: Metronomic Cyclophosphamide

Interventions

Cisplatin DRUG

25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks

Cisplatin - Metronomic Cyclophosphamide

Metronomic Cyclophosphamide DRUG

150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks

Also known as: Endoxan

Cisplatin - Metronomic Cyclophosphamide

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Jean Perrin: lead

Study Sites (1)

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cisplatin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Marie-Ange MOURET-REYNIER, MD

  Centre Jean Perrin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: July 30, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 18, 2018

Record last verified: 2016-07

Locations

FR (1)