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Combination Chemotherapy for Metastatic Breast Cancer

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Lilly

Status and phase

Completed
Phase 2

Conditions

Breast Cancer

Treatments

Drug: Gemcitabine
Drug: cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00191815
B9E-VI-S326
7311

Details and patient eligibility

About

The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

Enrollment

70 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • You are female in the age of 18 to 75 years old.
  • You have been diagnosed with the metastatic breast cancer.
  • You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
  • You must sign this informed consent form

Exclusion criteria

  • You are pregnant or breastfeeding.
  • Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
  • You have been diagnosed with serious concomitant or acute infectious disease.
  • You have used experimental medications within the last month.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

70 participants in 1 patient group

Gemcitabine + Cisplatin
Experimental group
Treatment:
Drug: cisplatin
Drug: Gemcitabine

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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