CompletedNCT00605267Updated Sep 6, 2012Results posted

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

A Phase 3 interventional study of Tamoxifen and Anastrazole (Arimidex) in Breast Cancer, sponsored by AstraZeneca. Completed at 4 sites in Japan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2012-09-06.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 197
Allocation: Randomized
Ages: 20 Years and older
Sex: Female

Study 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

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

Breast Cancer
Breast Neoplasms
Tumors or cancer of the human BREAST
Tumor or cancer of the human MAMMARY GLAND

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 197 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: 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

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).

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 197 participants (actual)

Study arms

Active comparator
1
Tamoxifen
Drug: Tamoxifen · Drug: Goserelin acetate (Zoladex)
Experimental
2
Anastrazole (Arimidex)
Drug: Anastrazole (Arimidex) · Drug: Goserelin acetate (Zoladex)

Interventions

DrugTamoxifen
20 mg once daily oral dose
Also known as: NOLVADEX
DrugAnastrazole (Arimidex)
1 mg once daily oral dose
Also known as: ARIMIDEX, ZD1033
DrugGoserelin acetate (Zoladex)
3.6mg/month depot injection
Also known as: ZOLADEX

What researchers measure

Primary outcomes

Best Overall Response Rate (BORR) (Calliper)
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.
Time frame: 24 weeks
Best Overall Response Rate (BORR) (US)
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.
Time frame: 24 weeks
Best Overall Response Rate (BORR) (MRI/CT)
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.
Time frame: 24 weeks

Secondary outcomes

Bone Mineral Density (BMD) Lumbar Spine
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.
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Mineral Density (BMD) Cervical Thighbone
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.
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (BAP) EIA Method
Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (BAP) CLEIA Method
Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method
Time frame: Assessed at baseline and after 24 weeks of treatment
Bone Turnover Marker (NTX)
Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks
Time frame: Assessed at baseline and after 24 weeks of treatment
Serum Oestrone (E1) Concentrations
Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time frame: Assessed at baseline and after 24 weeks of treatment
Serum Oestradiol (E2) Concentrations
Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.
Time frame: Assessed at baseline and after 24 weeks of treatment
Oestrogen Receptor (ER) Status
ER status in the ITT population is categorized as Positive or Negative
Time frame: Assessed at baseline and after 24 weeks of treatment
Progesterone Receptor (PgR) Status
PgR status in the ITT population is categorized as Positive or Negative.
Time frame: Assessed at baseline and after 24 weeks of treatment
Human Epidermal Growth Factor Receptor 2 (HER2) Status
HER2 status in the ITT population is categorized as Positive or Negative
Time frame: Assessed at baseline and after 24 weeks of treatment
Histopathological Response Rate (HRR)
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)
Time frame: Assessed at baseline and after 24 weeks of treatment
Functional Assessment of Cancer Therapy-Breast (FACT-B)
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.
Time frame: Assessed at baseline and after 24 weeks of treatment
Endocrine Subscale (ES)
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
Time frame: Assessed at baseline and after 24 weeks of treatment
Anastrozole Plasma Concentrations (Cmin)
Trough Plasma concentrations (Cmin) of Anastrozole - only Anastrozole arm was evaluated for Trough Plasma concentrations.
Time frame: Assessed at week 12

Results

Posted Sep 6, 2012

Participant flow

Participants were recruited from 4 research sites in Japan: Hakata (Fukuoka), Kumamoto (Kumamoto), Nagoya (Nagoya), Osaka (Osaka). The study initiation date was October 2007 and the study completion date was January 2010.

Participant flow — Overall Study
Milestone	Anastrozole 1 mg	Tamoxifen 20 mg
Started	98	99
Completed	95	90
Not completed	3	9
Withdrew: Adverse event	0	1
Withdrew: Lack of efficacy	1	5
Withdrew: Withdrawal by subject	2	3

Outcome measures

PrimaryBest Overall Response Rate (BORR) (Calliper)

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.

Time frame:: 24 weeks
Reported as:: Number · Percentage of Participants

Best Overall Response Rate (BORR) (Calliper)
Percentage of Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Best Overall Response Rate (BORR) (Calliper)	70.4	50.5

PrimaryBest Overall Response Rate (BORR) (US)

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.

Time frame:: 24 weeks
Reported as:: Number · Participants

Best Overall Response Rate (BORR) (US)
Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Best Overall Response Rate (BORR) (US)	58.2	42.4

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

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.

Time frame:: 24 weeks
Reported as:: Number · Percentage of Participants

Best Overall Response Rate (BORR) (MRI/CT)
Percentage of Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Best Overall Response Rate (BORR) (MRI/CT)	64.3	37.4

SecondaryBone Mineral Density (BMD) Lumbar Spine

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.

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · PercentageBMD=Patient's BMD/standard BMD

Bone Mineral Density (BMD) Lumbar Spine
PercentageBMD=Patient's BMD/standard BMD	Anastrozole 1 mg	Tamoxifen 20 mg
Bone Mineral Density (BMD) Lumbar Spine	-5.8 ± 3.4	-2.9 ± 2.5

SecondaryBone Mineral Density (BMD) Cervical Thighbone

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.

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · PercentageBMD=Patient'sBMD/standard BMD)

Bone Mineral Density (BMD) Cervical Thighbone
PercentageBMD=Patient'sBMD/standard BMD)	Anastrozole 1 mg	Tamoxifen 20 mg
Bone Mineral Density (BMD) Cervical Thighbone	-2.5 ± 5.1	-0.5 ± 3.2

SecondaryBone Turnover Marker (BAP) EIA Method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by EIA method

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · U/L

Bone Turnover Marker (BAP) EIA Method
U/L	Anastrozole 1 mg	Tamoxifen 20 mg
Bone Turnover Marker (BAP) EIA Method	7.1941 ± 6.1600	0.7333 ± 3.3640

SecondaryBone Turnover Marker (BAP) CLEIA Method

Change from baseline in serum Bone-Alkaline Phosphatase (BAP) at 24 weeks measured by CLEIA method

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · ug/L

Bone Turnover Marker (BAP) CLEIA Method
ug/L	Anastrozole 1 mg	Tamoxifen 20 mg
Bone Turnover Marker (BAP) CLEIA Method	3.96 ± 4.60	-0.75 ± 3.10

SecondaryBone Turnover Marker (NTX)

Change from baseline in serum crosslinked N-Telopeptide of type I collagen (NTX) at 24 weeks

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · nmolBCE(Bone Collagen Equivalent) /L

Bone Turnover Marker (NTX)
nmolBCE(Bone Collagen Equivalent) /L	Anastrozole 1 mg	Tamoxifen 20 mg
Bone Turnover Marker (NTX)	9.17 ± 4.74	2.59 ± 3.23

SecondarySerum Oestrone (E1) Concentrations

Ratio of serum Oestrone (E1) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · Ratio

Serum Oestrone (E1) Concentrations
Ratio	Anastrozole 1 mg	Tamoxifen 20 mg
Serum Oestrone (E1) Concentrations	0.028 ± 0.036	0.341 ± 0.282

SecondarySerum Oestradiol (E2) Concentrations

Ratio of serum Oestradiol (E2) concentration (pg/mL) in the ITT population from baseline at 24 weeks.

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · Ratio

Serum Oestradiol (E2) Concentrations
Ratio	Anastrozole 1 mg	Tamoxifen 20 mg
Serum Oestradiol (E2) Concentrations	0.041 ± 0.092	0.082 ± 0.186

SecondaryOestrogen Receptor (ER) Status

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

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Number · Participants

Oestrogen Receptor (ER) Status
Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Baseline Positive & 24 weeks Negative	2	1
Baseline Positive & 24 weeks Positive	92	89
Baseline Negative & 24 weeks Negative	0	0
Baseline Negative & 24 weeks Positive	0	0

SecondaryProgesterone Receptor (PgR) Status

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

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Number · Participants

Progesterone Receptor (PgR) Status
Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Baseline Positive & 24 weeks Negative	60	19
Baseline Positive & 24 weeks Positive	29	59
Baseline Negative & 24 weeks Negative	4	9
Baseline Negative & 24 weeks Positive	1	3

SecondaryHuman Epidermal Growth Factor Receptor 2 (HER2) Status

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

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Number · Participants

Human Epidermal Growth Factor Receptor 2 (HER2) Status
Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Baseline Positive & 24 weeks Negative	0	0
Baseline Positive & 24 weeks Positive	0	0
Baseline Negative & 24 weeks Negative	92	88
Baseline Negative & 24 weeks Positive	2	2

SecondaryHistopathological Response Rate (HRR)

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)

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Number · Percentage of Participants

Histopathological Response Rate (HRR)
Percentage of Participants	Anastrozole 1 mg	Tamoxifen 20 mg
Histopathological Response Rate (HRR)	41.8	27.3

SecondaryFunctional Assessment of Cancer Therapy-Breast (FACT-B)

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.

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · Trial Outcome Index (TOI) (Prorated)

Functional Assessment of Cancer Therapy-Breast (FACT-B)
Trial Outcome Index (TOI) (Prorated)	Anastrozole 1 mg	Tamoxifen 20 mg
Functional Assessment of Cancer Therapy-Breast (FACT-B)	-4.42 ± 11.07	-2.65 ± 8.09

SecondaryEndocrine Subscale (ES)

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

Time frame:: Assessed at baseline and after 24 weeks of treatment
Reported as:: Mean · ES score

Endocrine Subscale (ES)
ES score	Anastrozole 1 mg	Tamoxifen 20 mg
Endocrine Subscale (ES)	-8.85 ± 8.69	-6.27 ± 8.93

SecondaryAnastrozole Plasma Concentrations (Cmin)

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

Time frame:: Assessed at week 12
Reported as:: Geometric mean · ng/mL

Anastrozole Plasma Concentrations (Cmin)
ng/mL	Anastrozole 1 mg	Tamoxifen 20 mg
Anastrozole Plasma Concentrations (Cmin)	29.7 (17.3 to 52.4)	—

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Anastrozole 1 mg	—	1/98 (1%)	87/98 (88.8%)
Tamoxifen 20 mg	—	0/98 (0%)	84/98 (85.7%)

Most frequent serious events

Most frequent serious events
Event	Anastrozole 1 mg	Tamoxifen 20 mg
Benign NeoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/98	0/98

Most frequent other events

Showing 10 of 17

Most frequent other events
Event	Anastrozole 1 mg	Tamoxifen 20 mg
Hot FlushVascular disorders	51/98	52/98
ArthralgiaMusculoskeletal and connective tissue disorders	35/98	20/98
NasopharyngitisInfections and infestations	27/98	24/98
Musculoskeletal StiffnessMusculoskeletal and connective tissue disorders	21/98	9/98
HeadacheNervous system disorders	20/98	15/98
ConstipationGastrointestinal disorders	4/98	13/98
InsomniaPsychiatric disorders	7/98	9/98
HyperhidrosisSkin and subcutaneous tissue disorders	4/98	8/98
Abdominal Pain UpperGastrointestinal disorders	5/98	6/98
Menopausal SymptomsReproductive system and breast disorders	6/98	4/98

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Anastrozole 1 mg	Tamoxifen 20 mg	Total
20-29 years	2	0	2
30-39 years	21	20	41
40-49 years	65	68	133
50-59 years	10	11	21

Sex: Female, Male
Sex: Female, Male(Participants)	Anastrozole 1 mg	Tamoxifen 20 mg	Total
Female	98	99	197
Male	0	0	0

Study locations

4 sites

Research Site
Hakata, Fukuoka, Japan
Research Site
Kumamoto, Japan
Research Site
Nagoya, Japan
Research Site
Osaka, Japan

References and documents

Publications

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. PubMed 22265697 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00605267
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Jan 31, 2008
Start date: Oct 2007
Primary completion: Nov 2009
Completion: Dec 2010
Results posted: Sep 6, 2012
Last update: Sep 6, 2012

Study contacts

Toshiyuki Kihara

study director · Clinical

View the source record on ClinicalTrials.gov ↗

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