CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
gemcitabine +3 moredrug
Likely dose
Gemcitabine 1200 mg/m² IV on days 1 and 8 every 21 days for 4 cycles, then 1000 mg/m² IV on days 1 and 8 every 21 days for 4 cycles; doxorubicin 60 mg/m² IV every 21 days for 4 cycles; cisplatin 70 mg/m² IV every 21 days for 4 cyclesAI-extracted
Key inclusion· 5
  • ✓Histologically or cytologically confirmed breast carcinoma
  • ✓Large or locally advanced disease that is bidimensionally measurable
  • ✓No prior chemotherapy for breast cancer
  • ✓Karnofsky Performance Status (KPS) ≥70
Key exclusion· 4
  • ✕Inflammatory breast cancer
  • ✕Pregnancy or breast-feeding
  • ✕Serious concomitant medical disorder or infection
  • ✕Prior malignancy (other than breast cancer) within the last 5 years

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

Search/NCT00191789
NCT00191789Phase 2Completed
CompareCT.gov

Neoadjuvant Administration of Gemcitabine Plus Doxorubicin Followed by Gemcitabine Plus Cisplatin in Large or Locally Advanced Operable Breast Cancer: A Phase II Study

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Jul 27, 2010

In Brief

A Phase 2 clinical trial evaluating gemcitabine, doxorubicin, and 2 other interventions for Breast Cancer. Completed, enrolled 65 participants across 3 sites.

Detailed Summary

Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesIndia
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartFeb 1, 2003
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.8 years ago

Interventions

gemcitabinedrug

1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8)

doxorubicindrug

60 mg/m\^2, IV, every 21 days x 4 cycles (1-4)

cisplatindrug

70 mg/m\^2, IV, every 21 days x 4 cycles (5-8)

surgeryprocedure

Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.