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Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer

Phase 2
18 Years
75 Years
Not Enrolling
Breast Cancer

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Trial Information

Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer

Inclusion Criteria:

- Histologically confirmed metastatic breast cancer

- All patients were required to give written informed consent.

- Prior treatment with chemotherapy, hormonal therapy, immunotherapy or local
radiotherapy was allowed (except gemcitabine or platinum agents).

- Patients were required to have at least one bidimensionally measurable lesion outside
a previous radiation port.

- Age ≥ 18 years

- Karnofsky Performance status ≥ 70 %

- Minimal life expectancy of 12 weeks

- Adequate haematological, renal, cardiac and hepatic function:

1. Leukocyte count ≥ 3.0 x 109/l

2. Absolute neutrophil count ≥ 2.0 x 109/l

3. Platelet count ≥ 100 x 109/l

4. Haemoglobin ≥ 8 g/dl

5. Total serum bilirubin ≤ 1.25 x upper limit of normal (ULN) In presence of liver
metastasis ≤ 3 x ULN

6. Transaminase (ALT,AST) level ≤ 3 x ULN In presence of liver metastasis ≤ 5 x

7. Alkaline phosphatase level ≤ 2.5 x ULN

8. Creatinine clearance was required to exceed 60 ml/min.

Exclusion Criteria:

- Prior treatment with gemcitabine or platinum agents

- Inadequate creatinine clearance (< 60 ml/min)

- Only bone metastases

- Symptomatic brain metastases

- Women who are pregnant, lactating or refuse effective contraception

- Secondary malignancy

- History of another primary malignant disease other than in situ carcinoma of the
uterine cervix or adequately treated basal cell skin cancer

- Active infection

- Any other concomitant severe clinical condition making implementation of the protocol
including pre-hydration difficult.

Type of Study:


Study Design:

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

Principal Investigator

Volker Heinemann, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Munich - Klinikum Grosshadern


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Gem/Carbo MUC01



Start Date:

March 2004

Completion Date:

October 2006

Related Keywords:

  • Breast Cancer
  • pretreated
  • metastatic
  • Breast Neoplasms