CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 162 enrolled
Drug / intervention
chemotherapy +1 moredrug
Likely dose
Chemotherapy within 10 weeks after surgery; radiation therapy within 6 months after surgery (at least 40 Gy if no prior adjuvant radiotherapy)AI-extracted
Key inclusion· 6
  • Histologically confirmed invasive breast cancer
  • First local and/or regional recurrence (ipsilateral axillary or internal mammary lymph nodes) after primary mastectomy or lumpectomy/quadrantectomy
  • Surgical resection of recurrence with uninvolved ('clear') margins and planned radiotherapy of at least 40 Gy (if no prior adjuvant radiotherapy), OR mastectomy of recurrence with clear margins after lumpectomy for primary
  • Female, minimum 18 years old
Key exclusion· 9
  • No other prior recurrence in any site
  • No bilateral breast malignancy except carcinoma in situ
  • No suspicious mass in opposite breast unless proven benign by biopsy
  • No macroscopically incomplete surgery

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

Search/NCT00074152
NCT00074152Phase 3Completed

A Randomized Clinical Trial Of Adjuvant Chemotherapy For Radically Resected Loco-Regional Relapse Of Breast Cancer

ETOP IBCSG Partners Foundation·interventional·Posted Dec 11, 2003·Updated Jun 16, 2017

In Brief

A Phase 3 clinical trial evaluating chemotherapy and radiation therapy for Breast Cancer. Completed, enrolled 162 participants across 199 sites in 10 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether chemotherapy is effective in treating women who have undergone surgery and radiation therapy for relapsed breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of adjuvant chemotherapy in treating women who have undergone resection for local and/or regional relapsed breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesAustralia, Belgium, Canada, Hungary, Netherlands, Peru, South Africa, Spain, Switzerland, United States

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 11, 2003
Enrollment StartJul 1, 2002
Primary CompletionFeb 1, 2014
Study CompletionAug 22, 2016
TodayJul 2, 2026
Enrollment to primary: 11.6 yearsPosted 22.6 years ago

Interventions

chemotherapydrug

Given within 10 weeks after surgery.

radiation therapyradiation

Given within 6 months after surgery