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NCT00272740 Clinical Trial

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

Breast Neoplasms Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00272740
Other study ID # 9238SZ/0001
Secondary ID SAKK21/00
Status Completed
Phase Phase 2
First received January 4, 2006
Last updated February 8, 2007
Start date March 2000

Study information
Verified date February 2007
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Fulvestrant

Locations
Country Name City State
Belgium Research Site Leuven
Switzerland Research Site Aarau
Switzerland Research Site Bern
Switzerland Research Site Genf
Switzerland Research Site Lausanne
Switzerland Research Site Mendrisio
Switzerland Research Site Milano
Switzerland Research Site St.Gallen

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical Benefit Rate
Secondary Duration of clinical benefit
Secondary Time to progression
Secondary Duration of response
Secondary Time to treatment failure
Secondary Safety and tolerability
Secondary 6. clinical benefit rate according to HER2/neu status
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