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

AstraZeneca120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Breast Cancer

Interventions

FulvestrantDRUG

500 mg intramuscular injection

AnastrazoleDRUG

oral tablet

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Nottingham, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Surgery (SRG) was to be performed between days 15 and 22 after baseline (BL)

Data from ClinicalTrials.gov

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