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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

C

Centre Jean Perrin

Status and phase

Terminated
Phase 2

Conditions

Metastatic Breast Cancer

Treatments

Drug: Metronomic Cyclophosphamide
Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01910870
META1 - CJP4.1

Details and patient eligibility

About

To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.

Enrollment

4 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

4 participants in 1 patient group

Cisplatin - Metronomic Cyclophosphamide
Experimental group
Description:
Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks
Treatment:
Drug: Cisplatin
Drug: Metronomic Cyclophosphamide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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