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INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

Phase 1/Phase 2
18 Years
75 Years
Not Enrolling
Breast, Cancer

Thank you

Trial Information

INST: Phase I-II Study of Carboplatin, Vinorelbine and Capecitabine in Patients With Metastatic Breast Cancer

1. Determine the response rate with this regimen in an anthracycline and taxane resistant
cohort of patients.

2. Determine a maximum tolerated dose of capecitabine in combination with vinorelbine and
carboplatin for this patient population.

3. Determine the time to relapse after the administration of this regimen.

Inclusion Criteria:

- Patient must have a histological diagnosis of breast cancer with metastasis.

- The metastatic disease should be confirmed by biopsy if clinically indicated.

- The patient must have measurable or evaluable disease.

- Age > 18 years and < 75 years.

- The patient may not have received prior therapy with vinorelbine, capecitabine,
carboplatinum, or cisplatinum.

- The patient may have received herceptin previously.

- The patients must have previously received at least one cycle of chemotherapy.

- The patient must have received anthracycline and taxane containing chemotherapy in
the past. This may be either in the adjuvant setting or for metastatic disease.
Resistance is defined as progressive disease while on treatment, with or without an
initial response, or relapse/progression within 6 months of completing chemotherapy.

- Performance status < 2.

- At least 3 weeks must have elapsed since the completion of prior radiation therapy,
chemotherapy, or hormonal therapy. The patient must have recovered from all grade 3-4
associated toxicities at the time of registration. Measurable or evaluable disease
must be outside the previous radiation field or a new lesion must be present.

- Patients must not receive concurrent hormonal, or biologic therapy, or radiation
therapy to measurable or evaluable disease.

- The patient should not have uncontrolled CNS disease.

- Laboratory parameters: ANC > l500/ l, Platelets >100 000/ l, creatinine < 2.0,
bilirubin < 2.0

- Informed consent.

Type of Study:


Study Design:

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

Outcome Measure:

Measurable disease: Bidimensionally measurable lesions with clearly defined margins by 1) palpation with both diameters greater than 1 cm, 2) CT, MRI with both diameters greater than the distance between cuts of the imaging study.

Outcome Time Frame:

disease progression or unacceptable toxicities

Safety Issue:


Principal Investigator

Ian Rabinowitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico


United States: Institutional Review Board

Study ID:




Start Date:

May 2000

Completion Date:

March 2006

Related Keywords:

  • Breast
  • Cancer
  • Breast metastatic
  • Breast Neoplasms



University of New Mexico Albuquerque, New Mexico  87131