Microarray Analysis in breast cancer to Tailor Adjuvant Drugs Or Regimens, a randomized phase III study.
Completed
- Conditions
- Primary operable breast cancer
- Registration Number
- NL-OMON23149
- Lead Sponsor
- etherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 660
Inclusion Criteria
1. Women with pT1-T3, pN0-3b, M0 adenocarcinoma of the breast (TNM classification 2002). Women with a macrometastasis in the sentinel node, who did not receive an axillary dissection (pN1(sn)), are only eligible if radiotherapy of the axilla is included in the treatment plan (for instance experimental arm AMAROS study);
2. Known HER2 and estrogen receptor status;
Exclusion Criteria
1. Prior systemic anticancer therapy for any cancer (immunotherapy, hormonal therapy, chemotherapy);
2. Prior radiation therapy for breast cancer;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel—containing chemotherapy.<br>
- Secondary Outcome Measures
Name Time Method Is docetaxel-doxorubicin-cyclophosphamide (TAC) better than doxorubicin-cyclophosphamide dose-dense (AC dd) concerning DFS, RFS, breast cancer specific survival and all cause survival?<br /><br>Objectives of optional side studies:<br /><br>1. To determine whether the proteomic profile of patients, with primary breast cancer, relates to patient demographic characteristics, tumor stage, tumor biologic characteristics or tumor genetic (micro-array) profile;<br /><br>2. To identify a proteomic pattern that positively or negatively predicts relapse according to the genetic profile of the primary tumor (micro-array analysis) in each treatment arm;<br /><br>3. To identify a proteomic pattern in follow-up serum samples that can predict for relapse.