Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870168
• Other study ID #: CDR0000626717
• Secondary ID: JEANP-AU-613INCA
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: May 13, 2011
• Start date: January 2006

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Studying biopsy samples in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This clinical trial is studying biopsy samples in women who are receiving first-line chemotherapy for metastatic breast cancer.

Description:

OBJECTIVES:

Primary

• Evaluate the effect of first-line chemotherapy on expression of hormone receptors and biomarkers in women with metastatic breast cancer.

Secondary

• Assess changes in HER1 and HER2 expression during treatment.

OUTLINE: This is a multicenter study.

Patients receive 6-9 courses of front-line chemotherapy according to the investigator. Patients with estrogen receptor- and/or progesterone receptor-positive disease receive hormone therapy.

Patients undergo biopsy prior to and after completion of chemotherapy for examination of hormone receptors and HER1 and HER2 expression.

After completion of study treatment, patients are followed every 6 months for 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Metastatic disease

• No inflammatory breast cancer

• Measurable disease according to RECIST criteria

• Hormone receptor status:

• Estrogen receptor- and/or progesterone receptor-negative by IHC

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• WHO performance status 0-2

• Life expectancy > 3 months

• ANC > 1.5 x 10^9/L

• Platelet count > 100 x 10^9/L

• Liver transaminases = 3 times upper limit of normal (ULN)

• Alkaline phosphatase = 3 times ULN

• Bilirubin = 1.5 times ULN

• Creatinine = 2 times ULN

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No allergy to xylocaine

• No heart failure, or kidney, bone marrow, respiratory, or liver insufficiency

PRIOR CONCURRENT THERAPY:

• No prior first-line treatment for metastatic disease

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• chemotherapy

Genetic:
• gene expression analysis

Other:
• laboratory biomarker analysis

Procedure:
• breast biopsy

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in hormone receptor expression			No