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Study of Tumor and Blood Samples From Women With Breast Cancer

Colon and Breast Cancer Diagnostics. Clinical Protocol Associated With Cancer of the Breast.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00897728
Enrollment
180
Registered
2009-05-12
Start date
2008-02-29
Completion date
Unknown
Last updated
2010-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

Brief summary

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.

Detailed description

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.

Interventions

OTHERlaboratory biomarker analysis

Sponsors

Institut Curie
Lead SponsorOTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Local or remote relapse as assessed by biomarkers in tissue and blood samples collected during the first 2 years after diagnosis

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026