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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


Phase 2
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

AstraZeneca Faslodex Medical Science Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United Kingdom: Department of Health

Study ID:

D6997C00057

NCT ID:

NCT00259090

Start Date:

April 2004

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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