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A Phase II Trial of Gemcitabine (Gemzar) Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

A Phase II Trial of Gemcitabine (Gemzar) Combined With Vinorelbine as First Line Chemotherapy for Metastatic Breast Cancer

Inclusion Criteria

Inclusion Criteria-

- Histological or cytological diagnosis of breast carcinoma with evidence of
unresectable, locally recurrent, or metastatic disease. Lesions should not be
amenable to surgery or radiation of curative intent.

- Presence of metastatic or local-regional recurrent disease, according to the American
Joint Committee on Cancer (Greenz, et al, 2002).

- Uni-dimensionally measurable lesions with clearly defined margin that are clearly
measurable by following methods according to computerized tomography (CT), Chest
x-ray or clinical examination, according to RECIST criteria (Therasse, et al, 2002).

- No prior chemotherapy for metastatic or locoregionally recurrent disease. Prior
adjuvant or neoadjuvant chemotherapy with Anthracyclines based regimen is mandatory.
The time from the last dose of prior adjuvant chemotherapy and study entry must be at
least 30 days and patients must have completely recovered from all acute chemotherapy
related toxicities (with exception of alopecia).

- Prior radiotherapy must be completed at least 30 days before study entry.

- No concurrent hormonal therapy for MBC. Prior hormonal therapy is allowed, the time
from the last dose of prior hormonal therapy for breast cancer to study enrollment
must be at least 1 week.

Exclusion Criteria -

- Have received treatment within the last 30 days with an investigational drug for any
indication before study entry.

- Concurrent administration of other tumor therapy, including cytotoxic chemotherapy,
surgery of cancer, radiotherapy, hormonal therapy and immunotherapy (including

- Active infection that in the opinion of the investigator would compromise the
patient's ability to tolerate therapy, unless adequately treated.

- Pregnancy or breast-feeding.

- Serious concomitant disorders that would compromise the safety of the patient or
compromise the patient's ability to complete the study, at the discretion of the

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:

To evaluate the response rate of Gemcitabine-vinorelbine when used in a 3-weekly as first line chemotherapy in patients with metastatic breast cancer.

Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Egypt: Institutional Review Board

Study ID:




Start Date:

July 2004

Completion Date:

June 2007

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms