Study of Tumor and Blood Samples From Women With Breast Cancer
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 Recruiting
Recruitment status was Recruiting
Sponsor:
Institut Curie
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897728
First received: May 9, 2009
Last updated: November 30, 2010
Last verified: July 2009
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Purpose
RATIONALE: Studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This research study is looking at tumor and blood samples from women with breast cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast. |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis [ Designated as safety issue: No ]
| Estimated Enrollment: | 180 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Assess relapse locally or remotely using biomarkers collected from primary tumor and blood samples from women with breast cancer during the first 2 years after diagnosis.
Secondary
- Evaluate all relapses.
- Assess survival without relapse.
- Determine correlation between biomarkers and relapse.
OUTLINE: Primary tumor and blood samples collected during usual care of patients during the first 2 years after diagnosis are analyzed for biomarkers useful in monitoring and diagnosing breast cancer.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of infiltrating unilateral breast cancer
- No in situ disease (ductal or lobular)
- No invasive bilateral synchronous disease
-
Breast cancer at high risk, defined by at least 2 of the following factors:
- Hormone receptor negative (HR-)
- Axillary node positive
- Histopathologic grade III
- High mitotic index (as defined by the Curie Institute as > 20 mitoses per 10 high-power fields [HPF])
- Tumor size ≥ 2 cm
- HER2-positive (3 + IHC or FISH/ICHS positive)
- Triple-negative tumors (HR- and HER2-negative)
- Initial thoracic-abdomino-pelvic and bone scans must be negative
- Underwent initial surgery
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Serum calcium normal (15.3 mg/dL) or normalized within 8 weeks after surgery
- No other invasive cancer within the past 5 years
- Not pregnant or nursing
- No psychological, familial, social, or geographical reasons that make monitoring impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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: NCT00897728
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897728
Locations
| France | |
| Institut Curie Hopital | Recruiting |
| Paris, France, 75248 | |
| Contact: Paul-Henri Cottu 33-3-8393-5005 | |
Sponsors and Collaborators
Institut Curie
Investigators
| Study Chair: | Paul-Henri Cottu | Institut Curie |
More Information
| ClinicalTrials.gov Identifier: | NCT00897728 History of Changes |
| Other Study ID Numbers: | CDR0000599189 CLCC-IC-COBRED-SEIN CLCC-IC-2007-11 CLCC-RECF0632 |
| Study First Received: | May 9, 2009 |
| Last Updated: | November 30, 2010 |
| 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 HER2-positive breast cancer triple-negative breast cancer estrogen receptor-negative breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on September 28, 2016