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A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Randomized, Open-Label, Multicenter, Phase II Study Comparing the Effects on Proliferation and the Efficacy and Tolerability of Fulvestrant (FASLODEX®) 500 mg With Fulvestrant (FASLODEX®) 250 mg When Given as Neoadjuvant Treatment in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer (T2, 3, 4b, N0-3, M0).


Inclusion Criteria:



- Postmenopausal women defined as women who have stopped having menstrual periods

- Written informed consent to participate in the trial

- Biopsy confirmation of invasive breast cancer

- Evidence of hormone sensitivity

- Willingness to undergo biopsies

Exclusion Criteria:

- Any previous treatment for breast cancer

- Unwillingness to stop taking any drug known to affect sex hormonal status or a
patient in which it would be inappropriate to stop.

- Any severe concurrent condition that would preclude surgery or that would jeopardize
compliance with the study, e.g., uncontrolled cardiac disease or uncontrolled
diabetes mellitus

- The presence of more than one primary tumor

- History of hypersensitivity to castor oil

- History of known bleeding disorders

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Anti-proliferative effect after 4 weeks of treatment.

Principal Investigator

AstraZeneca Faslodex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

9238IL/0065

NCT ID:

NCT00093002

Start Date:

June 2004

Completion Date:

July 2007

Related Keywords:

  • Breast Cancer
  • Early Breast Cancer
  • neoadjuvant therapy
  • hormonal treatment
  • newly diagnosed breast cancer
  • Estrogen Receptor Positive Breast Cancer
  • treatment naïve
  • neoadjuvant treatment
  • neoadjuvant setting
  • invasive breast cancer
  • Breast Neoplasms

Name

Location

Research SiteBentonville, Arkansas  
Research SiteBeverly, Massachusetts  
Research SiteAlbuquerque, New Mexico  
Research SiteAllentown, Pennsylvania  
Research SiteChattanooga, Tennessee  
Research SiteAbilene, Texas