Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00605267
- Lead Sponsor
- AstraZeneca
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 197
- Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Goserelin acetate (Zoladex) Tamoxifen 2 Goserelin acetate (Zoladex) Anastrazole (Arimidex) 1 Tamoxifen Tamoxifen 2 Anastrazole (Arimidex) Anastrazole (Arimidex)
- Primary Outcome Measures
Name Time Method Best Overall Response Rate (BORR) (Calliper) 24 weeks 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.Best Overall Response Rate (BORR) (US) 24 weeks 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.Best Overall Response Rate (BORR) (MRI/CT) 24 weeks 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.
- Secondary Outcome Measures
Name Time Method Bone Mineral Density (BMD) Lumbar Spine Assessed at baseline and after 24 weeks of treatment 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.
Bone Turnover Marker (BAP) EIA Method Assessed at baseline and after 24 weeks of treatment Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method
Serum Oestrone (E1) Concentrations Assessed at baseline and after 24 weeks of treatment Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Bone Mineral Density (BMD) Cervical Thighbone Assessed at baseline and after 24 weeks of treatment 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.
Bone Turnover Marker (NTX) Assessed at baseline and after 24 weeks of treatment Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks
Serum Oestradiol (E2) Concentrations Assessed at baseline and after 24 weeks of treatment Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Human Epidermal Growth Factor Receptor 2 (HER2) Status Assessed at baseline and after 24 weeks of treatment HER2 status in the ITT population is categorized as Positive or Negative
Histopathological Response Rate (HRR) Assessed at baseline and after 24 weeks of treatment 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)
Progesterone Receptor (PgR) Status Assessed at baseline and after 24 weeks of treatment PgR status in the ITT population is categorized as Positive or Negative.
Anastrozole Plasma Concentrations (Cmin) Assessed at week 12 Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.
Bone Turnover Marker (BAP) CLEIA Method Assessed at baseline and after 24 weeks of treatment Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method
Oestrogen Receptor (ER) Status Assessed at baseline and after 24 weeks of treatment ER status in the ITT population is categorized as Positive or Negative
Functional Assessment of Cancer Therapy-Breast (FACT-B) Assessed at baseline and after 24 weeks of treatment 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.Endocrine Subscale (ES) Assessed at baseline and after 24 weeks of treatment 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
Trial Locations
- Locations (1)
Research Site
🇯🇵Osaka, Japan