Study of Tumor Tissue Samples From Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
Southwest Oncology Group
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00949013
First received: July 29, 2009
Last updated: May 21, 2011
Last verified: July 2009
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313 will respond to doxorubicin and cyclophosphamide.
PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial SWOG-9313.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: immunohistochemistry staining method Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Evaluation of the Expression of the Cancer Stem Cell Marker ALDH1 as a Predictor of Adjuvant Chemotherapy Response in Breast Cancers of High Risk Women in SWOG-9313 |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Correlation of ALDH1 with disease-free survival and overall survival [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR) [ Designated as safety issue: No ]
| Estimated Enrollment: | 1600 |
| Study Start Date: | January 2009 |
OBJECTIVES:
Primary
- To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with adjuvant doxorubicin and cyclophosphamide on clinical trial SWOG-9313.
Secondary
- To determine associations of ALDH1 expression with other known factors that have been determined on clinical trial SWOG-9313, such as estrogen receptor (ER) status, HER2 status, TOPOII, cyclin E, and p27.
- To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup within ER and HER2 subgroups in patients treated on clinical trial SWOG-9313.
OUTLINE: This is a multicenter study.
Tumor tissue samples from clinical trial SWOG-9313 are analyzed for ALDH1 expression by IHC.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
- Tumor samples collected from women diagnosed with early-stage breast cancer on clinical trial SWOG-9313 available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00949013 History of Changes |
| Other Study ID Numbers: | CDR0000632885, SWOG-S9313B-ICSC |
| Study First Received: | July 29, 2009 |
| Last Updated: | May 21, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IA breast cancer stage IB breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 21, 2013