Studieoverzicht - 2005-03 MINDACT

 
Number 2005-03 MINDACT
Nickname MINDACT
Status Follow up Date: 01-07-2011
Inclusion closed
Other study number(s) EORTC 10041; BIG 3-04; CKTO 2007
Participating parties/groups EORTC, BIG, TRANSBIG
Full title 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 clinicalpathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes.
Phase and type Randomized Phase III
Age > 18 and < 70 yrs
Menopausal status Both pre- and postmenopausal
Indication Adjuvant
Subindication Any HER2, any HR
Target sample size 6000
Actual accrual 6589 (NL 2071) Date: 01-08-2011
Estimated study completion date 01-07-2011
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2005-002625-31
Trial Register NCT00433589
METC approval Yes Date: 23-01-2006 METC: Academisch Ziekenhuis Maastricht Nr: MEC 06-2-016.19
Amendments Yes Date: 25-04-2008
KWF-CKS approval Yes Date: 02-04-2007 Nr: CKTO 2007
News item
Website http://www.bigagainstbreastcancer.org/our-research/clinical-trials/big-3-04-mindact/
Sponsor EORTC
Principal Investigator(s) E.J.Th. Rutgers
Study manager J. Remmelzwaal
Central datamanagement and randomization EORTC (European Organisation for Research and Treatment of Cancer)
Avenue E. Mounier 83-11
B-1200, Brussels, Belgium
www.eortc.be
Tel +32 2 774 16 11
Monitoring
Local datamanagement IKNL
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF
Extra

Design:

Randomization for treatment decision making tool (R-T) of discordant cases (clinical-pathological prognosis using "Adjuvant! Online" versus: 
gene expression prognosis using the 70-gene signature), with additional randomizations for chemotherapy (R-C) and endocrine therapy (R-E) comparisons.

Objectives:

Primary:

  • To demonstrate the superiority of the molecular profiling approach over the usual clinical assessment in assigning adequate risk categories (and the need to receive adjuvant chemotherapy or not) to breast cancer patients with 0 to 3 positive lymph nodes.
  • To compare a docetaxel-capecitabine regimenpossibly associated with increased efficacy and reduced long-term toxicities to existing commonly used anthracycline-based chemotherapy regimens (anthracyclines followed by docetaxel for node positive).
  • To determine the best endocrine treatment strategy i.e. single agent up-front, aromatase inhibitor (AI) (letrozole) for seven years compared to the sequential endocrine strategy of 2 years of tamoxifen followed by 5 years of letrozole.

Secondary:

  • Comparison of the two prognostic methods:
  • To estimate both relative (Hazard Ratio, HR) and absolute (as % at 5 years) efficacy in terms of disease free survival (DFS), distant metastasis free survival (DMFS) and overall survival (OS) of chemotherapy in the two subgroups where the clinical-pathological prognosis and the 70-gene signature molecular prognosis are discordant.
  • To calculate overall estimates of efficacy (DFS, DMFS, OS) for each treatment strategy according to clinical-pathological prognosis and according to molecular prognosis.
  • To estimate the percentage of patients receiving chemotherapy per each prognostic method.

Gene profiling:

  • To identify and/or validate predictive gene expression profiles of clinical response/resistance to anthracycline-based and docetaxelcapecitabine chemotherapy.
  • The identification and validation of novel gene expression signatures predicting clinical response to sequential tamoxifen-AI versus AI alone.
Endpoints:

Primary enpoint: 

  • For R-T the primary endpoint is DMFS at 5 years.
  • For R-C and R-E the primary endpoint is DFS at 5 years.

Secondary endpoints:

  • the proportion of women treated with chemotherapy per treatment decision making tool i.e. clinical prognosis compared to the 70-gene signature prognosis,
  • OS at 5 and 10 years
  • DFS and safety (both early and late)
Main eligibility criteria:
  • Histologically proven operable invasive breast cancer, with 0 to 3 positive lymph nodes and no distant metastases;
  • T1, T2 or operable T3
  • Unilateral,
  • Frozen tumor sample (not fixed in formalin) must be available
Documents (public):
Documents (protected):
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