Phase 2 N=70 Treatment

Combination Chemotherapy for Metastatic Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00191815 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Aug 2009

Primary outcome: Primary: Objective Tumor Response — 7; 19; 19; 5 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Gemcitabine (Drug); cisplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Eli Lilly and Company
Primary completion: —

Outcome Measures

Outcome	Result	p-value
PRIMARY Objective Tumor Response	7; 19; 19; 5; 4	—
SECONDARY Duration of Response	32.7	—
SECONDARY Time to Progressive Disease	33.9	—
SECONDARY Time to Treatment Failure	26.2	—
SECONDARY Survival Time	84.0	—
SECONDARY Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination	1; 1; 0; 0; 1; 0	—
SECONDARY Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades	35; 20; 5; 1; 6; 25	—
SECONDARY Number of Deaths	35; 1; 1	—
SECONDARY Number of Participants With Adverse Events Leading to Discontinuation	2; 1; 1	—

Summary

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

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00191815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.