Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment

Breast Cancer Clinical Trial

Official title:

Multi-centre, Randomised, Double-blind, Parallel-group Study to Compare Efficacy and Safety Between Anastrozole (ZD1033) and Tamoxifen in Pre- and Post-operative Administration Under Goserelin Acetate Treatment for Premenopausal Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00605267
• Other study ID #: D539BC00001
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2008
• Last updated: August 3, 2012
• Start date: October 2007
• Est. completion date: December 2010

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this multi-centre, randomised, double-blind, parallel-group study is to compare efficacy and safety between anastrozole and tamoxifen in pre- and post-operative administration under goserelin acetate treatment for premenopausal breast cancer patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent

Exclusion Criteria:

• Medical history of chemotherapy or endocrine therapy for breast cancer, or with treatment history of radiotherapy. Unwillingness to stop taking any drug known to affect sex hormone status (including hormone replacement therapy (HRT).

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen
20 mg once daily oral dose
• Anastrazole (Arimidex)
1 mg once daily oral dose
• Goserelin acetate (Zoladex)
3.6mg/month depot injection

Locations

Country	Name	City	State
Japan	Research Site	Hakata	Fukuoka
Japan	Research Site	Kumamoto
Japan	Research Site	Nagoya
Japan	Research Site	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Overall Response Rate (BORR) (Calliper)	The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement).; CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	24 weeks	No
Primary	Best Overall Response Rate (BORR) (US)	The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement).; CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	24 weeks	No
Primary	Best Overall Response Rate (BORR) (MRI/CT)	The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement).; CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.	24 weeks	No
Secondary	Bone Mineral Density (BMD) Lumbar Spine	Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at lumbar spine.	Assessed at baseline and after 24 weeks of treatment	Yes
Secondary	Bone Mineral Density (BMD) Cervical Thighbone	Change from baseline in Bone Mineral Density value (percentage), in all subjects who used DXA(Dual-energy X-ray absorptiometry) method throughout the study, at 24 weeks measured at cervical thighbone.	Assessed at baseline and after 24 weeks of treatment	Yes
Secondary	Bone Turnover Marker (BAP) EIA Method	Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method	Assessed at baseline and after 24 weeks of treatment	Yes
Secondary	Bone Turnover Marker (BAP) CLEIA Method	Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method	Assessed at baseline and after 24 weeks of treatment	Yes
Secondary	Bone Turnover Marker (NTX)	Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks	Assessed at baseline and after 24 weeks of treatment	Yes
Secondary	Serum Oestrone (E1) Concentrations	Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Serum Oestradiol (E2) Concentrations	Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Oestrogen Receptor (ER) Status	ER status in the ITT population is categorized as Positive or Negative	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Progesterone Receptor (PgR) Status	PgR status in the ITT population is categorized as Positive or Negative.	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Human Epidermal Growth Factor Receptor 2 (HER2) Status	HER2 status in the ITT population is categorized as Positive or Negative	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Histopathological Response Rate (HRR)	Number of patients in the ITT population defined as histopathological responders over the total number of patients x 100. An histopathological responder = a patient classified as Grade 1b, 2 or 3 for the histopathological response (Grade 0 = no response, 1a = mild response, 1b = moderate response, 2 = marked response or 3 = complete response)	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Functional Assessment of Cancer Therapy-Breast (FACT-B)	Change from baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B)in the ITT population at 24 weeks. Trial Outcome Index (TOI) = the sum of the Physical Well-Being (PWB), Functional Well-Being (FWB), and Breast Cancer Scale (BCS) subscales of FACT-B.; FACT-B includes 36 questions; 7 in PWB (Physical Well-Being); 7 inSWB (Social / Family Well-Being); 6 in EWB (Emotional Well-Being); 7 in FWB (Functional Well-Being); 9 in BCS (Breast Cancer Subscale).; Total score of subscores or TOI is calculated from each score of question. Higher score means better and lower score means worthier.; Score range; 0-28 in PWB; 0-28 in SWB; 0-24 in EWB; 0-28 in FWB; 0-36 in BCS; 0-92 in TOI.	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Endocrine Subscale (ES)	Change from baseline in Endocrine Symptom Subscale (ES)) in the ITT population at 24 weeks. ES score = the sum of the responses to all the questions on ES, low scores reflect poor quality of life and high scores reflects better quality of life.; Score range: 0-72	Assessed at baseline and after 24 weeks of treatment	No
Secondary	Anastrozole Plasma Concentrations (Cmin)	Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.	Assessed at week 12	No