Anti-tumour Effects & Tolerability of Faslodex Alone or in Combination With Arimidex in Post Menopausal Women Prior to Surgery for Primary Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrazole; Drug: Fulvestrant

• Registration Number: NCT00259090
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-11-25
• Study First Submitted QC: 2005-11-25
• Study First Posted: 2005-11-29
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-11-03
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-09
• Last Update Submitted: 2012-07-09
• Results First Posted: 2012-08-16
• Last Update Posted: 2012-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrazole	Anastrozole Monotherapy
2	Fulvestrant	Fulvestrant Monotherapy
3	Fulvestrant	Anastrozole + Fulvestrant
3	Anastrazole	Anastrozole + Fulvestrant

Primary Outcome Measures

Name	Time	Method
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.	Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)	For each sample, the ER H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent +/-) + (1 x percent +) + (2 x percent ++) + (3 x percent +++)\]. Range 0-300. The greater the change from baseline (randomization) in ER H-score, the greater the blockage of ER expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
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.	Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)	For each sample, the PgR H-score is calculated from the percentage of cells staining very weak (+/-); weak (+); moderate (++); or strong (+++) as follows: H-score = \[(0.5 x percent+/-) + (1 x percent+) + (2 x percent++) + (3 x percent+++)\]. Range 0-300. The greater the change from baseline (randomization in PgR H-score, the greater the blockage of PgR expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100
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.	Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)	For each sample, the Ki67 labelling index is calculated as the percentage of cells stained positive for Ki67. Range 0-100. The greater the change from baseline (randomization) in Ki67 labelling index, the greater the blockage of Ki67 expression and the greater the potential anti-tumour activity. Percentage change from baseline=\[(SRG - BL)/BL\]x100

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom