CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 633 enrolled
Drug / intervention
Standard Treatment +1 moredrug
Likely dose
CMF: Cyclophosphamide 100 mg/m² PO days 1-14 + Methotrexate 40 mg/m² IV days 1 & 8 + 5-FU 600 mg/m² IV days 1 & 8 every 28 days for 6 cycles OR AC: Doxorubicin 60 mg/m² IV + Cyclophosphamide 600 mg/m² IV every 21 days for 4 cycles; or Capecitabine 2000 mg/m² PO days 1-14 with 7-day rest, repeated for 6 cyclesAI-extracted
Key inclusion· 7
  • ✓Age 65 years or older
  • ✓Operable, histologically confirmed adenocarcinoma of the female breast
  • ✓TNM Stage T1-4 (tumor >1 cm), N0, M0 or T1-4, N1-3, M0
  • ✓HER2/neu positive, negative, or unknown disease eligible
Key exclusion· 3
  • ✕History of hypersensitivity to 5-FU or known DPD deficiency
  • ✕Invasive tumor at final resection margin for lumpectomy patients
  • ✕Gross or microscopic invasive tumor at surgical margins for mastectomy patients

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

Search/NCT00024102
NCT00024102Phase 3Completed
CompareCT.gov

A Randomized Trial of Adjuvant Chemotherapy With Standard Regimens, Cyclophosphamide, Methotrexate and Fluorouracil - (CMF) or Doxorubicin and Cyclophosphamide - (AC), Versus Capecitabine in Women 65 Years and Older With Node Positive or Node-Negative Breast Cancer

Alliance for Clinical Trials in Oncology·interventional·Posted Jan 27, 2003·Updated Aug 12, 2016

In Brief

A Phase 3 clinical trial evaluating Standard Treatment and capecitabine for Breast Cancer. Completed, enrolled 633 participants across 334 sites in 3 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them in different ways after surgery may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating older women with breast cancer. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work in treating older women who have undergone surgery for breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesCanada, Peru, United States
CollaboratorsNational Cancer Institute (NCI), NCIC Clinical Trials Group

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartSep 1, 2001
Primary CompletionMay 1, 2008
Study CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 23.4 years ago

Interventions

Standard Treatmentdrug

Cyclophosphamide 100 mg/sq m PO d 1-14 + MTX 40 mg/sq m IV push d 1 \& 8 and 5-FU 600 mg/sq m IV push d 1 \& 8 q 28 days for 6 cycles OR doxorubicin 60 mg/sq m IV d 1 + cyclophosphamide 600 mg/sq m IV d 1 q 21 d for 4 cycles

capecitabinedrug

2000 mg/sq m PO d 1-14, 7 day rest then repeat for a total of 6 cycles