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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01910870
Recruitment Status : Terminated (Because of difficulties in recruiting)
First Posted : July 30, 2013
Last Update Posted : May 18, 2018
Information provided by (Responsible Party):
Centre Jean Perrin

Brief Summary:
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Cisplatin Drug: Metronomic Cyclophosphamide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cisplatin - Metronomic Cyclophosphamide
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
25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks

Drug: Metronomic Cyclophosphamide
150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks
Other Name: Endoxan

Primary Outcome Measures :
  1. Response rate of cisplatin - metronomic cyclophosphamide treatment [ Time Frame: 18 months and 6 weeks ]

Secondary Outcome Measures :
  1. Disease free progression [ Time Frame: 3 years ]
  2. safety profile of cisplatin - metronomic cyclophosphamide association [ Time Frame: 18 months and 6 weeks ]
    Number of Participants with Adverse Events

  3. Overall survival [ Time Frame: 5 years ]
  4. Predictive factors to response and/or resistance treatment [ Time Frame: 18 months and 6 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01910870

Centre Jean Perrin
Clermont-Ferrand, France, 63011
Sponsors and Collaborators
Centre Jean Perrin
Principal Investigator: Marie-Ange MOURET-REYNIER, MD Centre Jean Perrin

Responsible Party: Centre Jean Perrin Identifier: NCT01910870     History of Changes
Other Study ID Numbers: META1 - CJP4.1
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: July 2016

Keywords provided by Centre Jean Perrin:

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists