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
Overview
- Phase
- Phase 2
- Intervention
- Anastrazole
- Conditions
- Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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.
Arms & Interventions
1
Anastrozole Monotherapy
Intervention: Anastrazole
2
Fulvestrant Monotherapy
Intervention: Fulvestrant
3
Anastrozole + Fulvestrant
Intervention: Fulvestrant
3
Anastrozole + Fulvestrant
Intervention: Anastrazole
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.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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