Phase 3
Completed N=514
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
Source: ClinicalTrials.gov NCT00256698 ↗Enrolled (actual)
514
Serious AEs
16.7%
Results posted
Feb 2011
Primary outcomePrimary: Time to Progression (TTP) — 10.8; 10.2 months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
10.8; 10.2 | — |
| SECONDARY Percentage of Evaluable Participants With Objective Response Rate (ORR) |
31.8; 33.6 | — |
| SECONDARY Percentage of Clinical Benefit Rate (CBR) Responders |
55.0; 55.1 | — |
| SECONDARY Duration of Response (DoR) |
22.3; 18.2 | — |
| SECONDARY Duration of Clinical Benefit (DoCB) |
18.5; 18.1 | — |
| SECONDARY Time to Treatment Failure (TTF) |
12.4; 11.4 | — |
| SECONDARY Overall Survival (OS) |
37.8; 38.2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00256698). 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. Informational only — not medical advice.