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

NCT00259090 | Completed Phase 2 Results

• 2 other identifiers: D6997C000579238IL/0057
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (3)

1

ACTIVE COMPARATOR

Anastrozole Monotherapy

Drug: Anastrazole

2

EXPERIMENTAL

Fulvestrant Monotherapy

Drug: Fulvestrant

3

EXPERIMENTAL

Anastrozole + Fulvestrant

Drug: Fulvestrant; Drug: Anastrazole

Interventions

Fulvestrant DRUG

500 mg intramuscular injection

Also known as: Faslodex, ZD9238

2; 3

Anastrazole DRUG

oral tablet

Also known as: Arimidex, ZD1033

1; 3

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous treatment with any anti-hormonal therapy for breast cancer.
• Previous radiotherapy to the primary tumour.
• Previous chemotherapy for the primary tumour.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Nottingham, United Kingdom

Location

Related Publications (1)

• Robertson JF, Dixon JM, Sibbering DM, Jahan A, Ellis IO, Channon E, Hyman-Taylor P, Nicholson RI, Gee JM. A randomized trial to assess the biological activity of short-term (pre-surgical) fulvestrant 500 mg plus anastrozole versus fulvestrant 500 mg alone or anastrozole alone on primary breast cancer. Breast Cancer Res. 2013 Mar 5;15(2):R18. doi: 10.1186/bcr3393.

  PMID: 23497452 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• AstraZeneca Faslodex Medical Science Director, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2005
• First Posted: November 29, 2005
• Study Start: April 1, 2004
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 16, 2012
• Results First Posted: August 16, 2012

Record last verified: 2012-07

Locations

GB (1)