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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00870168

Enrollment

Registered

2009-03-27

Start date

2006-01-31

Completion date

Unknown

Last updated

2011-05-16

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

Conditions

Breast Cancer

Keywords

stage IV breast cancer, estrogen receptor-negative breast cancer, progesterone receptor-negative breast cancer

Brief 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.

Detailed 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.

Interventions

DRUGchemotherapy

GENETICgene expression analysis

OTHERlaboratory biomarker analysis

PROCEDUREbreast biopsy

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Changes in hormone receptor expression	—

Countries

France

Outcome results

None listed

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