Skip to main content
OpenTrials
Completed

NCT Number: NCT00605267

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Hakata, Fukuoka, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Tamoxifen

Drug

20 mg once daily oral dose

Other names: NOLVADEX

Anastrazole (Arimidex)

Drug

1 mg once daily oral dose

Other names: ARIMIDEX, ZD1033

Goserelin acetate (Zoladex)

Drug

3.6mg/month depot injection

Other names: ZOLADEX

Primary outcomes

  1. Best Overall Response Rate (BORR) (Calliper)

    Time frame: 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.

  2. Best Overall Response Rate (BORR) (US)

    Time frame: 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.

  3. Best Overall Response Rate (BORR) (MRI/CT)

    Time frame: 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 outcomes

  1. Bone Mineral Density (BMD) Lumbar Spine

    Time frame: 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.

  2. Bone Mineral Density (BMD) Cervical Thighbone

    Time frame: 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.

  3. Bone Turnover Marker (BAP) EIA Method

    Time frame: 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

  4. Bone Turnover Marker (BAP) CLEIA Method

    Time frame: 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

  5. Bone Turnover Marker (NTX)

    Time frame: 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

  6. Serum Oestrone (E1) Concentrations

    Time frame: 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.

  7. Serum Oestradiol (E2) Concentrations

    Time frame: 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.

  8. Oestrogen Receptor (ER) Status

    Time frame: Assessed at baseline and after 24 weeks of treatment

    ER status in the ITT population is categorized as Positive or Negative

  9. Progesterone Receptor (PgR) Status

    Time frame: Assessed at baseline and after 24 weeks of treatment

    PgR status in the ITT population is categorized as Positive or Negative.

  10. Human Epidermal Growth Factor Receptor 2 (HER2) Status

    Time frame: Assessed at baseline and after 24 weeks of treatment

    HER2 status in the ITT population is categorized as Positive or Negative

  11. Histopathological Response Rate (HRR)

    Time frame: 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)

  12. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Time frame: 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.

  13. Endocrine Subscale (ES)

    Time frame: 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

  14. Anastrozole Plasma Concentrations (Cmin)

    Time frame: Assessed at week 12

    Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jan 31, 2008
Registry last updated
Sep 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.