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Breast CancerPhase 3NCT00605267

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

A Phase 3 study testing Tamoxifen, Anastrazole (Arimidex) and Goserelin acetate (Zoladex) in people with Breast Cancer, run by AstraZeneca at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 20 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Tamoxifen, Anastrazole (Arimidex) and Goserelin acetate (Zoladex)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
4 sitesJapan
Study dates
Oct 2007to Dec 2010
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Premenopausal, estrogen receptor positive women, aged 20 years and over, with operable and measurable breast cancer who have provided written informed consent

Who cannot join

  • 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).

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Research Site

    Hakata, Fukuoka

  • Research Site

    Kumamoto, Kumamoto

  • Research Site

    Nagoya, Nagoya

  • Research Site

    Osaka, Osaka

Other trials in Japan

About this study

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

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
Breast Cancer
Being tested
Tamoxifen, Anastrazole (Arimidex), Goserelin acetate (Zoladex)
Keywords
Breast Cancer, Breast Neoplasms, Tumors or cancer of the human BREAST, Tumor or cancer of the human MAMMARY GLAND
Medical subject headings
Breast Neoplasms, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TamoxifenDrug

    Also called NOLVADEX

    20 mg once daily oral dose

  • Anastrazole (Arimidex)Drug

    Also called ARIMIDEX, ZD1033

    1 mg once daily oral dose

  • Goserelin acetate (Zoladex)Drug

    Also called ZOLADEX

    3.6mg/month depot injection

Study groups in NCT00605267
Study groupRoleWhat they receive
1Active comparatorTamoxifen
Receives: Drug: Tamoxifen; Drug: Goserelin acetate (Zoladex)
2ExperimentalAnastrazole (Arimidex)
Receives: Drug: Anastrazole (Arimidex); Drug: Goserelin acetate (Zoladex)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks

  2. 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.

    Measured: 24 weeks

  3. 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.

    Measured: 24 weeks

Secondary outcomes (14)

  1. 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.

    Measured: Assessed at baseline and after 24 weeks of treatment

  2. 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.

    Measured: Assessed at baseline and after 24 weeks of treatment

  3. Bone Turnover Marker (BAP) EIA Method

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  4. Bone Turnover Marker (BAP) CLEIA Method

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  5. Bone Turnover Marker (NTX)

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  6. Serum Oestrone (E1) Concentrations

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  7. Serum Oestradiol (E2) Concentrations

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  8. Oestrogen Receptor (ER) Status

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  9. Progesterone Receptor (PgR) Status

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

    Measured: Assessed at baseline and after 24 weeks of treatment

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

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

    Measured: Assessed at baseline and after 24 weeks of treatment

  11. 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)

    Measured: Assessed at baseline and after 24 weeks of treatment

  12. 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.

    Measured: Assessed at baseline and after 24 weeks of treatment

  13. 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

    Measured: Assessed at baseline and after 24 weeks of treatment

  14. Anastrozole Plasma Concentrations (Cmin)

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

    Measured: Assessed at week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2008 (estimated)
  2. Study startOct 2007
  3. Primary completionNov 2009
  4. Study completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00605267
Sponsor's protocol ID
D539BC00001
Status last verified
Aug 2012
First submitted
9 Jan 2008
Last updated
6 Sep 2012

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tamoxifen, Anastrazole (Arimidex) and Goserelin acetate (Zoladex) in people with Breast Cancer, run by AstraZeneca at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Best Overall Response Rate (BORR) (Calliper) (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00605267, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.

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