CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
Capecitabine +1 moredrug
Likely dose
Imatinib 400 mg orally daily plus Capecitabine 1,000 mg/m² orally twice daily on Days 1-14 of each 21-day cycleAI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed adenocarcinoma of the breast
  • Stage IV measurable disease
  • Disease progression after 1-2 prior chemotherapy regimens for metastatic disease
  • Hormone-sensitive tumors must have received prior hormonal therapy
Key exclusion· 8
  • No clinical evidence of or known brain or CNS disease
  • No prior capecitabine or fluorouracil for metastatic breast cancer
  • No other malignancy within the past 5 years except adequately treated skin cancer or cervical carcinoma in situ
  • No history of severe hypersensitivity reaction to imatinib mesylate, capecitabine, or fluorouracil

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

Search/NCT00087152
NCT00087152Phase 2Completed

Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 12, 2004·Updated Jun 9, 2014

In Brief

A Phase 2 clinical trial evaluating Capecitabine and Imatinib mesylate for Breast Cancer. Completed, enrolled 27 participants.

Detailed Summary

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining imatinib mesylate with capecitabine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with capecitabine works in treating women with progressive stage IV breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2004
Enrollment StartJun 1, 2004
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 22.0 years ago

Interventions

Capecitabinedrug

1,000 mg/m\^2 by mouth twice daily Days 1-14 of each 21 day cycle

Imatinib mesylatedrug

400 mg by mouth daily