CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 135 enrolled
Drug / intervention
Pemetrexed +3 moredrug
Likely dose
Pemetrexed 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00325234
NCT00325234Phase 2Completed

A Randomized Phase II Study of Two Chemotherapy Regimens, Pemetrexed-Carboplatin, and Gemcitabine-Vinorelbine, in Anthracycline and Taxanes Pretreated Advanced Breast Cancer Patients

Eli Lilly and Company·interventional·Posted May 12, 2006·Updated May 20, 2011

In Brief

A Phase 2 clinical trial evaluating Pemetrexed, Carboplatin, and 2 other interventions for Breast Cancer. Completed, enrolled 135 participants across 22 sites in 5 countries.

Detailed Summary

The primary purpose of this study is to help answer the following research questions: * whether the chemotherapy combination therapy Pemetrexed-Carboplatin or Gemcitabine-Vinorelbine can help participants with advanced breast cancer to make the tumor smaller or disappear and for how long * to learn more about the side effects in each chemotherapy combination treatment arm * to assess how participants with advanced breast cancer report health changes while receiving any of the chemotherapy combination arm

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesGermany, Italy, South Africa, Spain, Turkey (Türkiye)
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 12, 2006
Enrollment StartJun 1, 2006
Primary CompletionApr 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.1 years ago

Interventions

Pemetrexeddrug

600 mg/m\^2, administered intravenously (IV) every 21 days until disease progression or unacceptable toxicity.

Carboplatindrug

AUC 5 mg\*min/mL, administered IV every 21 days until disease progression or unacceptable toxicity.

Gemcitabinedrug

1200 mg/m\^2 gemcitabine, administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.

Vinorelbinedrug

30 mg/m\^2 vinorelbine administered IV on day 1 and day 8 every 21 days until disease progression or unacceptable toxicity.