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ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741


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

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Trial Information

ER/HER2/Ki67 Breast Cancer Subtypes as Predictive Factors for Response to Adjuvant Dose-dense Therapy, and Basal Subtypes of Double-negative Breast Cancer as Prognostic Factors in Intergroup Trial C9741


OBJECTIVES:

Primary

- To identify biomarkers that can be used to individually tailor the use of adjuvant
dose-dense therapy in women with stage II or IIIA breast cancer.

Secondary

- To identify groups of patients who have a poor prognosis despite adjuvant chemotherapy
and who should be prospectively targeted for new approaches to adjuvant treatment.

OUTLINE: This is a multicenter study.

Tissue samples are collected from patients. Tissue samples are analyzed by
immunohistochemistry (Ki67, CK5/6, EGFR, ER) and fluorescence in situ hybridization (FISH).

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of node-positive breast cancer

- Stage II-IIIA disease

- Underwent adjuvant chemotherapy on trial CLB-9741 or CLB-9344

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Matthew J. Ellis, MD, PhD, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

Washington University Siteman Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000589237

NCT ID:

NCT00897026

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

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