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Relationship of pAKT to Survival in Patients With Node-Positive Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00965276
First received: August 24, 2009
Last updated: March 14, 2014
Last verified: December 2010
  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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 2500
Study Start Date: January 2004
Estimated Study Completion Date: December 2010
Detailed Description:

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
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965276

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  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: March 14, 2014
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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014