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.
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
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
- Conditions
- Breast Neoplasms
- 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.
FulvestrantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate
Secondary outcomes (6)
Duration of clinical benefit
Time to progression
Duration of response
Time to treatment failure
Safety and tolerability
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.
- First posted9 Jan 2006 (estimated)
- Study startMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Switzerland Medical Director, MD, Study director, AstraZeneca
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