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

Study Overview
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Brief Summary
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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.

Official Title
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A Double-blind, Randomized, Multicentre Trial to Compare the Anti-tumour Effects and Tolerability of a 500 mg Dose of Faslodex (Fulvestrant) Plus Arimidex (Anastrozole) With a 500 mg Dose of Faslodex(Fulvestrant) Alone and With Arimidex(Anastrozole) Alone, in Postmenopausal Women Prior to Surgery for Primary Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Fulvestrant
* Drug: Anastrazole


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Anastrozole Monotherapy | Drug: Anastrazole<br>* oral tablet<br>* Other names: ZD1033;|
| Experimental: 2<br>Fulvestrant Monotherapy | Drug: Fulvestrant<br>* 500 mg intramuscular injection<br>* Other names: ZD9238;|
| Experimental: 3<br>Anastrozole + Fulvestrant | Drug: Fulvestrant<br>* 500 mg intramuscular injection<br>* Other names: ZD9238;Drug: Anastrazole<br>* oral tablet<br>* Other names: ZD1033;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | 
| 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. | 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 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) | 
| 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. | 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 | Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL) |