Phase 2
N=13
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00357110 ↗Enrolled (actual)
13
Serious AEs
23.1%
Results posted
Jan 2010
Primary outcome: Primary: Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) — 6; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fulvestrant (Drug); Anastrozole (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) |
6; 7 | — |
Summary
Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation
Exclusion Criteria
- Inflammatory and/or metastatic breast cancer.
- Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
- History of bleeding diathesis.
Data sourced from ClinicalTrials.gov (NCT00357110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.