Clinical trial · Interventional
Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer
A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow
NCT00357110CI-TRIAL-00004212@FAMEcompletedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
| Fulvestrant | Drug | Fulvestrant | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Anastrozole monotherapy
- interventionNames
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- 2
- description
- Anastrozole + Fulvestrant
- interventionNames
- Drug: Fulvestrant
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)
- timeFrame
- 12 month period following randomisation
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.