Clinical trial · Interventional
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.
- 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)
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of 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
- interventionNames
- Drug: Anastrozole
- type
- EXPERIMENTAL
- label
- 2
- description
- Anastrozole + Fulvestrant
- interventionNames
- Drug: Fulvestrant
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Time to Progression (TTP)
- timeFrame
- RECIST assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent, postmenopausal females, histological or cytological confirmed oestrogene and/or progesterone (PgR) receptor positive breast cancer, local recurrence or metastasis Exclusion Criteria: * Previous systemic endocrine therapy for advanced or recurrent disease; prior fulvestrant therapy * Premenopausal women
References
Publications (0)
Data not yet available