Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer
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Purpose
This study will examine the relationship of a protein called pAKT to survival of breast cancer patients with one or more positive axillary lymph nodes. Akt plays a role in cell survival, tumor formation, and the development of drug resistance.
The study will use tumor tissue obtained from 2,000 patients enrolled in a National Surgical Adjuvant Breast and Bowel Project study that is evaluating whether adding the drug paclitaxel (Taxol (Registered Trademark)) to a treatment regimen of doxorubicin (Adriamycin (Registered Trademark)) and cyclophosphamide (Cytoxan (Registered Trademark)) improves disease-free survival and overall survival in patients with node-positive breast cancer. The current study will measure levels of pAkt in the tissues and correlate the results with clinical outcome to see if pAkt levels are associated with improved patient survival.
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| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Official Title: | Levels of Phosphorylated AKT in Patients With Node-Positive Breast Cancer: Correlation With Disease-Free and Overall Survival |
| Enrollment: | 2500 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | December 2010 |
Taxanes (paclitaxel and docetaxel) have emerged as the most powerful chemotherapeutics in breast cancer over the past decades. The B-28 clinical trial from the National Surgical Adjuvant Breast and Bowel Project (NSABP) assesses the efficacy of adding paclitaxel to the doxorubicin/cyclophosphamide regimen in the treatment of patients with axillary node positive breast cancer. The primary aim of B-28 is to determine whether four cycles of paclitaxel (Taxol (Registered Trademark)) (T) following four cycles of postoperative Doxorubicin (adriamycin (Registered Trademark) (A) and cyclophosphamide (C) will more effectively prolong disease-free survival (DFS) and survival (S) than four cycles of AC alone in patients with operable breast cancer who have one or more histologically positive axillary lymph nodes. The B-28 clinical trial tissue microarray consists of specimens from 2,000 cases enrolled. The tissue microarray set is an ideal platform for evaluating predictive markers of doxorubicin and/or paclitaxel response or resistance.
Akt, a serine/threonine protein kinase regulated by the phosphatidylinositol 3-kinase (PI3K), is of importance in cell survival, tumorigenesis, and recently shown, chemoresistance. It confers survival advantage to cells by transducing signals from growth factor receptors that activate PI3K. The primary aim of this study is to evaluate whether the levels of phosphorylated AKT are associated with disease-free and overall survival in patients with node-positive breast cancer treated with AC and/or AC followed by paclitaxel.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA
The NSABP B-28 trial enrolled women from 1995 to 1998 with operable breast cancer with pathologically positive axillary lymph nodes.
Contacts and Locations
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00965276 History of Changes |
| Obsolete Identifiers: | NCT00896870 |
| Other Study ID Numbers: | 040088, 04-C-0088 |
| Study First Received: | August 24, 2009 |
| Last Updated: | December 15, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Adjuvant Therapy Paclitaxel Chemoresistance |
Serine/Threonine Kinase Cell Survival Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013