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 | https://www.eortc.org/research_field/clinical-detail/10041/ | ||||
| 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 |
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| Monitoring | ||||
| Local datamanagement | IKNL | |||
| Funding |
 Funding by KWF |
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| 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):
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