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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00605267
First received: January 9, 2008
Last updated: August 3, 2012
Last verified: August 2012

January 9, 2008
August 3, 2012
October 2007
November 2009   (final data collection date for primary outcome measure)
  • 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.

The primary objective of this study is to compare the tumour response rate between an anastrozole patient group and a tamoxifen group, during 24 weeks pre-operative administration, for premenopausal breast cancer patients receiving Zoladex 3.6mg/month
Complete list of historical versions of study NCT00605267 on ClinicalTrials.gov Archive Site
  • 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.
Safety of anastrozole and tamoxifen groups by: adverse events, lab. tests, blood pressure, pulse rate, WHO performance status and change in bone mineral density and bone turnover markers. Additional efficacy markers [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Breast Cancer
  • Drug: Tamoxifen
    20 mg once daily oral dose
    Other Name: NOLVADEX
  • Drug: Anastrazole (Arimidex)
    1 mg once daily oral dose
    Other Names:
    • ARIMIDEX
    • ZD1033
  • Drug: Goserelin acetate (Zoladex)
    3.6mg/month depot injection
    Other Name: ZOLADEX
  • Active Comparator: 1
    Tamoxifen
    Interventions:
    • Drug: Tamoxifen
    • Drug: Goserelin acetate (Zoladex)
  • Experimental: 2
    Anastrazole (Arimidex)
    Interventions:
    • Drug: Anastrazole (Arimidex)
    • Drug: Goserelin acetate (Zoladex)
Masuda N, Sagara Y, Kinoshita T, Iwata H, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H, Noguchi S. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial. Lancet Oncol. 2012 Apr;13(4):345-52. doi: 10.1016/S1470-2045(11)70373-4. Epub 2012 Jan 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
December 2010
November 2009   (final data collection date for primary outcome measure)

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).
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00605267
D539BC00001
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Toshiyuki Kihara Clinical
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP