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Breast NeoplasmsPhase 2NCT00272740

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

A Phase 2 study testing Fulvestrant in people with Breast Neoplasms, run by AstraZeneca at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Fulvestrant
How many people
93 participants
Where
8 sitesin 2 countries
Study dates
Mar 2000to not given
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Histological/cytological confirmation of breast cancer
  • progression under treatment with an aromatase inhibitor
  • At least one measurable or non-measurable lesion

Who cannot join

  • 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

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

Switzerland7 sites
  • Research Site

    Aarau

  • Research Site

    Bern

  • Research Site

    Geneva

  • Research Site

    Lausanne

  • Research Site

    Mendrisio

  • Research Site

    Milano

  • Research Site

    Sankt Gallen

Other trials in Switzerland

Belgium1 site
  • Research Site

    Leuven

Other trials in Belgium

About this study

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

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

Being tested
Fulvestrant
Keywords
breast cancer, fulvestrant, Faslodex, hormonotherapy, aromatase inhibitor failure, Advanced breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Benefit Rate

Secondary outcomes (6)
  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startMar 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272740
Sponsor's protocol ID
9238SZ/0001
Other IDs
SAKK, 21/00
Status last verified
Feb 2007
First submitted
4 Jan 2006
Last updated
9 Feb 2007
Results posted
No

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