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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00871858
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : March 30, 2009
Last Update Posted : January 10, 2011
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Brief 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: anastrozole Drug: fulvestrant Phase 2

Detailed 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Nonmetastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response
Study Start Date : January 2008
Estimated Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Arm I
Patients receive oral anastrozole once daily for 6 months.
Drug: anastrozole
Given orally

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




Primary Outcome Measures :
  1. Tumor response at 6 months of treatment according to RECIST criteria


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 84 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:

    • SBR grade I-II disease (patients < 65 years of age)
    • SBR grade I-III disease (patients > 65 years of age)
  • T2 (2-5 cm), T3, or T4B, and N0-1 disease
  • No metastatic disease
  • Breast lesion not amenable to breast-conserving resection
  • No inflammatory breast cancer
  • No prior breast cancer
  • Hormone receptor status:

    • Estrogen receptor- and/or progesterone receptor-positive

PATIENT CHARACTERISTICS:

  • Postmenopausal
  • No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix
  • No contraindication to anti-hormonal treatment
  • No psychological, familial, social, or geographical reasons that would preclude follow up

PRIOR CONCURRENT THERAPY:

  • At least 8 days since prior hormone replacement therapy
  • No concurrent anti-vitamin K treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871858


Locations
France
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Louis Mauriac, MD    33-56-333-258    mauriac@bergonie.org   
Sponsors and Collaborators
Institut Bergonié
Investigators
Principal Investigator: Louis Mauriac, MD Institut Bergonié

ClinicalTrials.gov Identifier: NCT00871858     History of Changes
Other Study ID Numbers: CDR0000633329
IB-HORGEN
IB-IB2007-26
INCA-RECF0514
EUDRACT-2007-004216-31
ZENECA-IB-HORGEN
First Posted: March 30, 2009    Key Record Dates
Last Update Posted: January 10, 2011
Last Verified: July 2009

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Estrogens
Estradiol
Fulvestrant
Anastrozole
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action