Studying Biopsy Samples in Women Undergoing First-Line Chemotherapy for Metastatic Breast Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: chemotherapy Genetic: gene expression analysis Other: laboratory biomarker analysis Procedure: breast biopsy |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Modifications of Hormone Receptors and Biological Parameters of Metastatic Breast Cancer Treated With First-line Chemotherapy. Prospective Biological Study. |
- Changes in hormone receptor expression [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2006 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00870168 History of Changes |
| Other Study ID Numbers: | CDR0000626717, JEANP-AU-613, INCA-RECF0389, JEANP-RH Meta Sein, PFIZER-JEANP-AU-613 |
| Study First Received: | March 26, 2009 |
| Last Updated: | May 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage IV breast cancer estrogen receptor-negative breast cancer progesterone receptor-negative breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013