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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00433589 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: capecitabine Drug: cyclophosphamide Drug: docetaxel Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: fluorouracil Drug: letrozole Drug: methotrexate Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Estimated Enrollment: | 6600 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | March 2019 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer meeting the following criteria:
Unilateral tumor
Operable disease
Must have undergone breast-conserving surgery or mastectomy with either a sentinel node procedure or full axillary clearance
Patients eligible for inclusion in the chemotherapy randomization must meet one of the following criteria:
Patients eligible for inclusion in the endocrine therapy randomization must meet all of the following criteria:
PATIENT CHARACTERISTICS:
No serious cardiac illness or medical condition including, but not limited to, any of the following:
Patients eligible for inclusion in the chemotherapy randomization must meet all of the following additional criteria:
PRIOR CONCURRENT THERAPY:
Patients eligible for inclusion in the chemotherapy randomization must meet all of the following additional criteria:
Patients eligible for inclusion in the endocrine therapy randomization must meet all of the following additional criteria:
No other concurrent treatment during endocrine therapy, including the following:
Hormonal contraceptives (including depot injections and implants)
Oral or transdermal hormonal treatments, including estrogen, progesterone, androgen, or aromatase inhibitor
Contacts and Locations| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Contact: Emiel J. T. Rutgers, MD, PhD, FRCS 31-20-512-2551 | |
| Investigator: | Emiel J. T. Rutgers, MD, PhD, FRCS | European Organization for Research and Treatment of Cancer - EORTC |
| Investigator: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
| Investigator: | Fatima Cardoso, MD | Champalimaud Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00433589 History of Changes |
| Other Study ID Numbers: | CDR0000526522, EORTC-10041, EUDRACT-2005-002625-31, BIG-3-04, EU-20676, NOVARTIS-EORTC-10041, ROCHE-EORTC-10041, SANOFI-AVENTIS-EORTC-10041 |
| Study First Received: | February 8, 2007 |
| Last Updated: | November 8, 2011 |
| Health Authority: | Unspecified |
|
invasive ductal breast carcinoma invasive lobular breast carcinoma stage IA breast cancer stage IB breast cancer |
stage II breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Cyclophosphamide Fluorouracil Methotrexate Docetaxel Letrozole Capecitabine Doxorubicin Epirubicin Tamoxifen |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Abortifacient Agents, Nonsteroidal |