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An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors


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

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Trial Information

An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors


Inclusion Criteria:



- Histological/cytological confirmation of breast cancer

- progression under treatment with an aromatase inhibitor

- At least one measurable or non-measurable lesion

Exclusion Criteria:

- Prior treatment for breast cancer with more than 2 different hormonal agents

- More than 1 chemotherapy for advanced disease

- Presence of life-threatening metastatic visceral disease

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Benefit Rate

Principal Investigator

AstraZeneca Switzerland Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Switzerland: Swissmedic

Study ID:

9238SZ/0001

NCT ID:

NCT00272740

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • fulvestrant
  • Faslodex
  • hormonotherapy
  • aromatase inhibitor failure
  • Advanced breast cancer
  • Breast Neoplasms
  • Neoplasms

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