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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00871858
First Posted: March 30, 2009
Last Update Posted: January 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
March 27, 2009
March 30, 2009
January 10, 2011
January 2008
September 2009   (Final data collection date for primary outcome measure)
Tumor response at 6 months of treatment according to RECIST criteria
Same as current
Complete list of historical versions of study NCT00871858 on ClinicalTrials.gov Archive Site
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Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: anastrozole
    Given orally
  • Drug: fulvestrant
    Given intramuscularly
  • Active Comparator: Arm I
    Patients receive oral anastrozole once daily for 6 months.
    Intervention: Drug: anastrozole
  • Experimental: Arm II
    Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.
    Intervention: Drug: fulvestrant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
114
Not Provided
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
up to 84 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00871858
CDR0000633329
IB-HORGEN
IB-IB2007-26
INCA-RECF0514
EUDRACT-2007-004216-31
ZENECA-IB-HORGEN
Not Provided
Not Provided
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Institut Bergonié
Not Provided
Principal Investigator: Louis Mauriac, MD Institut Bergonié
National Cancer Institute (NCI)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP