Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Tamoxifen Drug: Anastrazole (Arimidex) Drug: Goserelin acetate (Zoladex) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Best Overall Response Rate (BORR) (Calliper) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
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.
- Bone Mineral Density (BMD) Lumbar Spine [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: Yes ]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 Mineral Density (BMD) Cervical Thighbone [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: Yes ]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 (BAP) EIA Method [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: Yes ]Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method
- Bone Turnover Marker (BAP) CLEIA Method [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: Yes ]Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method
- Bone Turnover Marker (NTX) [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: Yes ]Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks
- Serum Oestrone (E1) Concentrations [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
- Serum Oestradiol (E2) Concentrations [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
- Oestrogen Receptor (ER) Status [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]ER status in the ITT population is categorized as Positive or Negative
- Progesterone Receptor (PgR) Status [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]PgR status in the ITT population is categorized as Positive or Negative.
- Human Epidermal Growth Factor Receptor 2 (HER2) Status [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]HER2 status in the ITT population is categorized as Positive or Negative
- Histopathological Response Rate (HRR) [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]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)
- Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]
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) [ Time Frame: Assessed at baseline and after 24 weeks of treatment ] [ Designated as safety issue: No ]
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
- Anastrozole Plasma Concentrations (Cmin) [ Time Frame: Assessed at week 12 ] [ Designated as safety issue: No ]Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.
| Enrollment: | 197 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Tamoxifen
|
Drug: Tamoxifen
20 mg once daily oral dose
Other Name: NOLVADEX
Drug: Goserelin acetate (Zoladex)
3.6mg/month depot injection
Other Name: ZOLADEX
|
|
Experimental: 2
Anastrazole (Arimidex)
|
Drug: Anastrazole (Arimidex)
1 mg once daily oral dose
Other Names:
Drug: Goserelin acetate (Zoladex)
3.6mg/month depot injection
Other Name: ZOLADEX
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Japan | |
| Research Site | |
| Hakata, Fukuoka, Japan | |
| Research Site | |
| Kumamoto, Japan | |
| Research Site | |
| Nagoya, Japan | |
| Research Site | |
| Osaka, Japan | |
| Study Director: | Toshiyuki Kihara | Clinical |
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: | NCT00605267 History of Changes |
| Other Study ID Numbers: | D539BC00001 |
| Study First Received: | January 9, 2008 |
| Results First Received: | November 26, 2010 |
| Last Updated: | August 3, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by AstraZeneca:
|
Breast Cancer Breast Neoplasms Tumors or cancer of the human BREAST Tumor or cancer of the human MAMMARY GLAND |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Goserelin Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013