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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00605267 (opens ClinicalTrials.gov in a new tab)Other idD539BC00001
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
197 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Triple masking
Countries
1 country

Japan

Start
Oct 2007
Primary completion
Nov 2009
Completion
Dec 2010
First posted
31 Jan 2008 (estimated)
Last update posted
6 Sept 2012 (estimated)
Conditions
Breast Cancer

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20072008200920102011
  1. Ph 3

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

    NCT00605267

    Oct 2007 to Dec 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TamoxifenDrug
  • Anastrazole (Arimidex)Drug
  • Goserelin acetate (Zoladex)Drug

Arms2

  • Active comparator

    1

    Tamoxifen

  • Experimental

    2

    Anastrazole (Arimidex)

Primary outcomes3

Outcomes the sponsor listed as primary.

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

    Time frame · 24 weeks

    Registry description

    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

    Registry description

    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

    Registry description

    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(14)

  1. Bone Mineral Density (BMD) Lumbar Spine

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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 weeks

Best Overall Response Rate (BORR) (Calliper)

GroupValue (Percentage of Participants)
Anastrozole 1 mg70.4
Tamoxifen 20 mg50.5
Primary outcomeNumber· 24 weeks

Best Overall Response Rate (BORR) (US)

GroupValue (Participants)
Anastrozole 1 mg58.2
Tamoxifen 20 mg42.4
Primary outcomeNumber· 24 weeks

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

GroupValue (Percentage of Participants)
Anastrozole 1 mg64.3
Tamoxifen 20 mg37.4
Secondary and other outcome results(5)
Secondary outcomeMean· Assessed at baseline and after 24 weeks of treatment

Bone Mineral Density (BMD) Lumbar Spine

GroupValue (PercentageBMD=Patient's BMD/standard BMD)Spread
Anastrozole 1 mg-5.83.4
Tamoxifen 20 mg-2.92.5
Secondary outcomeMean· Assessed at baseline and after 24 weeks of treatment

Bone Mineral Density (BMD) Cervical Thighbone

GroupValue (PercentageBMD=Patient'sBMD/standard BMD))Spread
Anastrozole 1 mg-2.55.1
Tamoxifen 20 mg-0.53.2
Secondary outcomeMean· Assessed at baseline and after 24 weeks of treatment

Bone Turnover Marker (BAP) EIA Method

GroupValue (U/L)Spread
Anastrozole 1 mg7.19416.1600
Tamoxifen 20 mg0.73333.3640
Secondary outcomeMean· Assessed at baseline and after 24 weeks of treatment

Bone Turnover Marker (BAP) CLEIA Method

GroupValue (ug/L)Spread
Anastrozole 1 mg3.964.60
Tamoxifen 20 mg-0.753.10
Secondary outcomeMean· Assessed at baseline and after 24 weeks of treatment

Bone Turnover Marker (NTX)

GroupValue (nmolBCE(Bone Collagen Equivalent) /L)Spread
Anastrozole 1 mg9.174.74
Tamoxifen 20 mg2.593.23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Anastrozole 1 mgAnastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection–1 / 9887 / 98
Tamoxifen 20 mgTamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection–0 / 9884 / 98

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2012

Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial.

Masuda et al. 2012The Lancet. Oncologycited by 134

PMID 22265697DOI 10.1016/s1470-2045(11)70373-4PUB-22265697

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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