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Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

Phase 2
18 Years
75 Years
Open (Enrolling)
Metastatic Breast Cancer

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Trial Information

Vinorelbine, Carboplatin and Trastuzumab in Advanced Her-2 Positive Breast Cancer, a Phase 2 Study

The addition of trastuzumab to chemotherapy containing anthracyclines or taxanes has
improved survival in patients with Her-2 positive metastatic breast cancer, but newer
combinations with less toxicity and cross resistance are needed. Early clinical studies have
suggested that the combination of vinorelbine, carboplatin and trastuzumab can be active
against metastatic breast cancer, with less toxicity. In this phase II single center trial,
39 patients will be enrolled to evaluate the activity and safety of this combination.

Inclusion Criteria:

- Histological or cytological diagnosis of breast cancer

- Stage IV disease

- None or at most one prior treatment for metastatic disease (prior treatment with
trastuzumab for metastatic disease is not permitted)

- Overexpression of HER-2 (immunohistochemistry 3+) or genetic amplification of
c-erbB2/neu (FISH+)

- ECOG Performance Status 0-2

- Age >18 and < 75 years

- Left Ventricular Ejection Fraction (LVEF) >50%

- Life expectancy >3 months

- Signed informed consent

Exclusion Criteria:

- Absence of measurable or evaluable disease

- Life expectancy < 3 months

- ECOG performance status > 2

- History of prior malignancy in the last 5 years (other than adequately treated
non-melanoma skin cancer or excised cervical carcinoma in situ).

- Previous chemotherapy with vinorelbine or carboplatin (as adjuvant therapy or for
metastatic disease)

- Previous therapy with trastuzumab for metastatic disease (previous adjuvant therapy
with trastuzumab is permitted)

- Neutrophil < 2000/mm3, platelets < 100,000/mm3, haemoglobin < 9 g/dl

- Creatinine > 1.5 x the upper normal limits

- GOT and/or GPT > 2.5 x the upper normal limits and/or Bilirubin > 1.5 x the upper
normal limits in absence of hepatic metastases

- GOT and/or GPT > 5 x the upper normal limits and/or Bilirubin > 3 x the upper
normal limits in presence of hepatic metastases

- Congestive hearth failure or history of congestive heart failure, unstable angina
pectoris even if it is medically controlled, myocardial infarction, clinically
significant valve disease, uncontrolled arrhythmia

- Any concomitant pathology that would, in the investigator's opinion, contraindicate
the use of the drugs in this study

- Male gender

- Pregnant or lactating women

- Refusal or incapacity to provide informed consent

- Inability to comply with follow up

Type of Study:


Study Design:

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

Outcome Measure:

objective response rate

Outcome Time Frame:

after 3 and 6 cycles of therapy

Safety Issue:


Principal Investigator

Andrea De Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C


Italy: Ethics Committee

Study ID:




Start Date:

October 2007

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • advanced
  • her-2 positive
  • Breast Neoplasms