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OpenTrials
Completed

NCT Number: NCT00272740

SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer

The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fulvestrant

Drug

Primary outcomes

  1. Clinical Benefit Rate

Secondary outcomes

  1. Duration of clinical benefit

  2. Time to progression

  3. Duration of response

  4. Time to treatment failure

  5. Safety and tolerability

  6. 6. clinical benefit rate according to HER2/neu status

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2000
First posted
Jan 9, 2006
Registry last updated
Feb 9, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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