Phase 2
Completed N=103
Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer
Source: ClinicalTrials.gov NCT00259090 ↗Enrolled (actual)
103
Serious AEs
4.2%
Results posted
Aug 2012
Primary outcomePrimary: Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score. — -37; -38; -7 Percentage change from baseline
Summary
To compare the anti-tumour effects as measured by changes in various biomarkers, of a combination of Faslodex and Arimidex with Faslodex alone and Arimidex alone in postmenopausal women patients with primary breast cancer who are awaiting curative-intent surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline to Time of Surgery in Oestrogen Receptor (ER) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the ER H-score. |
-37; -38; -7 | — |
| PRIMARY Percentage Change From Baseline to Time of Surgery in Progesterone Receptor (PgR) H-score: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the PgR H-score. |
-31; -38; -38 | — |
| PRIMARY Percentage Change From Baseline to Time of Surgery in Ki67 Labelling Index: Antitumour Effects of Fulvestrant, Anastrozole and a Combination of Both as Measured by the Ki67 Labelling Index. |
-62; -68; -75 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women.
- Biopsy confirmation of primary breast cancer.
- Oestrogen receptor positive tumour.
- Fit for surgery within one month.
- Written informed consent to participate in the study
Exclusion Criteria
- Previous treatment with any anti-hormonal therapy for breast cancer.
- Previous radiotherapy to the primary tumour.
- Previous chemotherapy for the primary tumour.
Data sourced from ClinicalTrials.gov (NCT00259090). 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.