CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,086 enrolled
Drug / intervention
Cyclophosphamide +1 moredrug
Likely dose
Cyclophosphamide 50 mg/day orally continuously for 1 year and Methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 yearAI-extracted
Key inclusion· 7
  • ✓Histologically confirmed stage I, II, or III breast cancer (T1-3, N0-2, M0)
  • ✓Estrogen and progesterone receptor negative (less than 10% positive tumor cells)
  • ✓Must have undergone prior total mastectomy or breast-conserving procedure with negative surgical margins
  • ✓Must have begun or be about to begin approved induction chemotherapy within 8 weeks after definitive surgery
Key exclusion· 9
  • ✕T4 disease with ulceration of skin, infiltration of skin (except pathologically minimal dermal involvement), peau d'orange, or inflammatory breast cancer
  • ✕Bilateral breast cancer (except in situ carcinoma) or suspicious mass in opposite breast not proven benign
  • ✕Prior adjuvant or neoadjuvant chemotherapy for breast cancer
  • ✕Prior endocrine therapy, tamoxifen, or raloxifene for breast cancer or prevention

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

Search/NCT00022516
NCT00022516Phase 3Completed
CompareCT.gov

Low-dose Cytotoxics as "Anti-angiogenesis Treatment" Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer

ETOP IBCSG Partners Foundation·interventional·Posted Jan 27, 2003·Updated Sep 16, 2016

In Brief

A Phase 3 clinical trial evaluating Cyclophosphamide and Methotrexate for Breast Cancer. Completed, enrolled 1,086 participants across 36 sites in 11 countries.

Detailed Summary

This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Brazil, Chile, Hungary, Italy, Nigeria, Peru, Romania, South Africa, Switzerland
Collaborators--

Timeline

Phase 3CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartNov 1, 2000
Primary CompletionJan 1, 2015
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 14.2 yearsPosted 23.4 years ago

Interventions

Cyclophosphamidedrug

50 mg/day orally continuously for 1 year

Methotrexatedrug

2.5 mg twice/day orally days 1 and 2 of every week for 1 year