CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,600 target
Drug / intervention
anthracycline-based +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00433589
NCT00433589Phase 3Completed

MINDACT (Microarray In Node-Negative and 1 to 3 Positive Lymph Node Disease May Avoid Chemotherapy): A Prospective, Randomized Study Comparing the 70-Gene Signature With the Common Clinical-Pathological Criteria in Selecting Patients for Adjuvant Chemotherapy in Breast Cancer With 0 to 3 Positive Nodes

European Organisation for Research and Treatment of Cancer - EORTC·interventional·Posted Feb 12, 2007·Updated Nov 17, 2022

In Brief

A Phase 3 clinical trial evaluating anthracycline-based, docetaxel and capecitabine, and 2 other interventions for Breast Cancer. Completed, enrolled 6,600 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Giving chemotherapy and hormone therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether genetic testing is more effective than clinical assessment in determining the need for chemotherapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying genetic testing to see how well it works compared with clinical assessment in determining the need for chemotherapy in women with breast cancer that is either node-negative or involves no more than 3 lymph nodes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesNetherlands

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 12, 2007
Enrollment StartFeb 1, 2007
Primary CompletionMar 1, 2020
TodayJul 2, 2026
Enrollment to primary: 13.1 yearsPosted 19.4 years ago

Interventions

anthracycline-baseddrug

docetaxel and capecitabinedrug

tamoxifendrug

Letrozoledrug