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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00259090
First received: November 25, 2005
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Drug: Anastrazole
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Enrollment: 120
Study Start Date: April 2004
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Anastrozole Monotherapy
Drug: Anastrazole
oral tablet
Other Names:
  • Arimidex
  • ZD1033
Experimental: 2
Fulvestrant Monotherapy
Drug: Fulvestrant
500 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Experimental: 3
Anastrozole + Fulvestrant
Drug: Fulvestrant
500 mg intramuscular injection
Other Names:
  • Faslodex
  • ZD9238
Drug: Anastrazole
oral tablet
Other Names:
  • Arimidex
  • ZD1033

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259090

Locations
United Kingdom
Research Site
Nottingham, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Faslodex Medical Science Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00259090     History of Changes
Other Study ID Numbers: D6997C00057, 9238IL/0057
Study First Received: November 25, 2005
Results First Received: November 3, 2009
Last Updated: July 9, 2012
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014