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NCT00075764 · ClinicalTrials.gov registry record · Phase 3
S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer
A Phase 3 study, sponsored by SWOG Cancer Research Network.
- Completed
- Registry status
- Phase 3
- Development phase
- 695
- Enrollment target
NCT00075764: Completed Phase 3 study, sponsored by SWOG Cancer Research Network.
NCT00075764 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 695 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00075764, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 695 participants
- Enrollment target
Study Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target measurable lesions over the smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician. Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without s
Interventions
- DRUG fulvestrant
- DRUG anastrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 695 participants |
| Start Date | 2004-04 |
| Est. Completion | 2018-10-01 |
| Phase | Phase 3 |
What the finished NCT00075764 record still lists
NCT00075764 is an interventional study that assigns participants to a tested intervention. The registered 695 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 2 interventions - of which fulvestrant is the first listed.
NCT00075764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00075764 about?
NCT00075764 is a clinical study titled "S0226 Anastrozole With or Without Fulvestrant as First-Line Therapy in Postmenopausal Women With Metastatic Breast Cancer". RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cance...
What is the current status of trial NCT00075764?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 695 participants. The study started on 2004-04. Estimated completion is 2018-10-01.
What interventions are being tested in trial NCT00075764?
The interventions under investigation include: fulvestrant (DRUG), anastrozole (DRUG).
Who is sponsoring clinical trial NCT00075764?
This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00075764's enrollment target sits among peer trials
695 518th of 2000 higher than 1,482 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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