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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

2014-08-27 03:23:17 | BioPortfolio

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether anastrozole is more effective than fulvestrant before surgery and radiation therapy in treating patients with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal patients with breast cancer.

Description

OBJECTIVES:

Primary

- Evaluate clinical tumor response at 6 months in patients with hormone-sensitive nonmetastatic breast cancer treated with neoadjuvant anastrozole vs fulvestrant.

Secondary

- Evaluate tumor regression by mammography and ultrasound in these patients.

- Evaluate the rate of breast conservation at 6 months of treatment in these patients.

- Evaluate the tolerability of these regimens.

- Estimate the progression-free survival at 5 years of these patients.

- Identify molecular signatures predictive of response in these patients.

- Identify genes implicated in response in these patients.

- Identify changes in mRNA splicing of genes involved in breast tumorigenesis.

OUTLINE: This is a multicenter study.

All patients undergo biopsy at baseline. Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral anastrozole once daily for 6 months.

- Arm II: Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.

Within 8 days after completion of hormone therapy, all patients undergo surgical resection of the residual lesion followed by radiotherapy. Patients then receive oral anastrozole once daily for 5 years.

Tissue samples from biopsy and surgery are analyzed to assess molecular signatures and sensitivity to treatment, and to compare gene expression variation with response.

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

anastrozole, fulvestrant

Location

Institut Bergonie
Bordeaux
France
33076

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:23:17-0400

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Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

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PubMed Articles [14534 Associated PubMed Articles listed on BioPortfolio]

Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer.

A meta-analysis of clinical benefit rates for fulvestrant 500 mg vs. alternative endocrine therapies for hormone receptor-positive advanced breast cancer.

Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC).

Pharmacokinetic and pharmacodynamic analysis of fulvestrant in preclinical models of breast cancer to assess the importance of its estrogen receptor-α degrader activity in antitumor efficacy.

Fulvestrant is a selective estrogen receptor downregulator (SERD) that is approved for first- or second-line use as a single agent or in combination with cyclin dependent kinase or phosphatidylinosit...

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Medical and Biotech [MESH] Definitions

Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).

Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.

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Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

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