Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00871858
First received: March 27, 2009
Last updated: January 7, 2011
Last verified: July 2009
  Purpose

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 Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: fulvestrant
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tumor response at 6 months of treatment according to RECIST criteria [ Designated as safety issue: No ]

Estimated Enrollment: 114
Study Start Date: January 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 84 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: March 27, 2009
Last Updated: January 7, 2011
Health Authority: Unspecified

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Fulvestrant
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014