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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Paul-Henri Cottu

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Curie

Authority:

Unspecified

Study ID:

CDR0000599189

NCT ID:

NCT00897728

Start Date:

February 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

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