Breast CancerPhase 3ASTRRANCT00912548

Evaluating the Role of the Addition of Ovarian Function Suppression (OFS) to Tamoxifen in Young Women

A Phase 3 study testing goserelin and tamoxifen in people with Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to compare 5-year disease free survival rate (DFS rate) between the hormone receptor positive breast cancer patients who were added Goserelin to Tamoxifen for ovarian function suppression after neo-/adjuvant cytotoxic chemotherapy and the hormone receptor positive breast cancer patients… Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: goserelin and tamoxifen
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,234 participants
Where: 1 siteSouth Korea
Study dates: May 2009to Dec 2015
Phase: Phase 3
Are there results?: None posted in the registry

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 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.
Patients must be within 3 months after the last cycle of chemotherapy.
Patients must have the history of normal menstruation prior to the start of chemotherapy.
Stage I, II or III
Woman, less than or equal to 45 years of age
Hormone receptor status : ER+ve and/or PgR+ve

Show all 10Show fewer

WHO performance status 0, 1 or 2.
Patients who were treated with cytotoxic chemotherapy in pre- or post- surgery.
Adequate haematological function defined by haemoglobin 10g/dL, neutrophil count 1.5x109/L and platelets 100x109/L.
Adequate hepatic function defined by AST and ALT 2.5xupper limit of normal. Alkaline phosphatase 5xupper limit of normal, unless bone metastases in the absence of liver disease. Renal function adequate defined by creatinine<175mmol/L.

Who cannot join

Patients whose primary breast cancer was classified as:
ER(-),ER unknown
Patients with the history of hysterectomy or oophorectomy
Sarcomas or squamous cell carcinomas of the breast are not eligible.
Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
Investigational drugs given within the previous 4 weeks.

Show all 10Show fewer

Patients known to be on any unlicensed non-cancer investigational agent.
Patients with thrombocytopaenia (platelets <100 x 109/l or on anti- coagulant therapy (contra-indicated due to risk of bleeding with i.m. injection of Zoladex).
Patients treated with CMF(cyclophosphamide/methotrexate/5-fluorouracil) as prior chemotherapy
Patients who are pregnant or lactating are ineligible.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Department of Surgery, Korea Cancer Center Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomised Phase III Study for Evaluating the Role of the Addition of Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain in Premenopause or Regain Menstruation After Chemotherapy

Read the detailed description

To compare overall Survival(OS) between the patients added Goserelin(ZOLADEXTM) to Tamoxifen and the patients treated with Tamoxifen alone in premenopausal status
To compare 5-year disease free survival rate (DFS rate) between the patients who took tamoxifen only in postmenopause and the patients added Goserelin(ZOLADEXTM) to Tamoxifen for inducing ovarian function suppression in premenopause
To determine the tolerability and safety of Tamoxifen with or without concomitant Zoladex

Conditions: Breast Cancer
Being tested: goserelin, tamoxifen
Keywords: premenopause, ovarian function suppression, tamoxifen
Medical subject headings: Breast Neoplasms

What participants receive

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

goserelinDrug
Also called Zoladex®
1. Zoladex™ administration: Zoladex™ depot is available as a sterile disposable syringe. The depot is administered subcutaneously under the abdominal skin under sterile conditions. If necessary the injection site may be pre-treated with a local anaesthetic.
2. Sequence of administration Zoladex depot: The substance is administered for 24 months (2 years) at 28-day intervals (a period of 34 days between 2 administrations must not be exceeded).
3. Dosage: Each depot contains 3.6mg Zoladex. The substance Zoladex is contained in a while cylindrical rodlet .
4. Storage instructions for Zoladex™ Zoladex™ is kept a room temperature.
tamoxifenDrug
Also called Nolvadex
1. Dose and period of Tamoxifen therapy: Tamoxifen is administered in tablet form. Each day 2 X 10 mg or 1 X 20 mg Tamoxifen are taken in the form of the respective tablet.
2. Storage instructions for Tamoxifen Tamoxifen is stored at room temperature away from light.

Study groups in NCT00912548
Study group	Role	What they receive
TAM+OFS(E) group	Experimental	Patients should be premenopausal women ,prior to the start of chemotherapy, less than or equal to 45 years of age with oestrogen receptor positive ± progesterone receptor positive who have undergone a primary mass excision, received an neo-/adjuvant chemotherapy ± radiotherapy for their stage I, II or III breast cancer. This arm is ovarian suppression group which have a various starting time of ovarian function suppression after neo-/adjuvant chemotherapy. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. After that, the patients will complete taking tamoxifen 20mg/day for 5 years. Receives: Drug: goserelin; Drug: tamoxifen
TAM(D) group	Active comparator	Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 0, 6, 12, 18 and 24 months since the baseline asTsessment(0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. The latter will complete taking tamoxifen 20mg/day for 5 years. Receives: Drug: tamoxifen
Permanent postmenopausal(A) group	No intervention	Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. Eligible patients except for premenopausal status at the baseline will be followed up until 2 years after the baseline assessment for evaluating the menopausal status. This group still remains to postmenopausal status and will taking tamoxifen 20mg/day for 5 years if they remain in the study.
TAM(B)	Active comparator	Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. This group, patients are premenopausal women, they will be randomized into tamoxifen only group, complete taking tamoxifen 20mg/day for 5 years. Receives: Drug: tamoxifen
TAM+OFS (C)	Experimental	Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized. This group, patients are premenopausal women, they will be randomized into the additional ovarian function suppression group. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. Then, Patients will complete taking tamoxifen 20mg/day for 5 years. Receives: Drug: goserelin; Drug: tamoxifen

What is being measured

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

all cause recurrence
Measured: the first 5 years after surgery

Timeline

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

May 2009Dec 2015

First posted3 Jun 2009 (estimated)
Study startMay 2009
Primary completionDec 2015 (estimated)
Study completionDec 2015 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Factorial
Masking: None (open label)
Enrolment: 1,234 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00912548
Sponsor's protocol ID: KBCSG005
Acronym: ASTRRA
Status last verified: Jun 2009
First submitted: 31 May 2009
Last updated: 16 Jun 2009
Results posted: No
Data monitoring committee: Yes

Publications

Kim HJ, Noh WC, Nam SJ, Park BW, Lee ES, Im SA, Jung YS, Yoon JH, Kang SS, Park KH, Lee SJ, Jeong J, Lee MH, Cho SH, Kim SY, Kim HA, Han SH, Han W, Hur MH, Kim S, Ahn SH. Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report. Eur J Cancer. 2021 Jul;151:190-200. doi: 10.1016/j.ejca.2021.03.017. Epub 2021 May 16.
PubMed 34010788
Kim HA, Lee JW, Nam SJ, Park BW, Im SA, Lee ES, Jung YS, Yoon JH, Kang SS, Lee SJ, Park KH, Jeong J, Cho SH, Kim SY, Kim LS, Moon BI, Lee MH, Kim TH, Park C, Jung SH, Gwak G, Kim J, Kang SH, Jin YW, Kim HJ, Han SH, Han W, Hur MH, Noh WC; Korean Breast Cancer Study Group. Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial. J Clin Oncol. 2020 Feb 10;38(5):434-443. doi: 10.1200/JCO.19.00126. Epub 2019 Sep 16.
PubMed 31518174
Kim HA, Ahn SH, Nam SJ, Park S, Ro J, Im SA, Jung YS, Yoon JH, Hur MH, Choi YJ, Lee SJ, Jeong J, Cho SH, Kim SY, Lee MH, Kim LS, Moon BI, Kim TH, Park C, Kim SJ, Jung SH, Park H, Gwak GH, Kang SH, Kim JG, Kim J, Choi SY, Lim CW, Kim D, Yoo Y, Song YJ, Kang YJ, Jung SS, Shin HJ, Lee KJ, Han SH, Lee ES, Han W, Kim HJ, Noh WC. The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): study protocol for a randomized controlled trial and progress. BMC Cancer. 2016 May 19;16:319. doi: 10.1186/s12885-016-2354-6.
PubMed 27197523

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Phase III Study for Evaluating the Role of the Addition of Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain in Premenopause or Regain Menstruation After Chemotherapy
ClinicalTrials.gov ID: NCT00912548
Acronym / sponsor ID: ASTRRA / KBCSG005
Conditions: Breast Cancer
Keywords: premenopause, ovarian function suppression, tamoxifen
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 1,234 participants (estimated)
Lead sponsor: Korean Breast Cancer Study GroupUniversity, hospital or other
Study start: May 2009
Primary completion: Dec 2015 (estimated)
Study completion: Dec 2015 (estimated)
First posted: 3 Jun 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To compare overall Survival(OS) between the patients added Goserelin(ZOLADEXTM) to Tamoxifen and the patients treated with Tamoxifen alone in premenopausal status
To compare 5-year disease free survival rate (DFS rate) between the patients who took tamoxifen only in postmenopause and the patients added Goserelin(ZOLADEXTM) to Tamoxifen for inducing ovarian function suppression in premenopause
To determine the tolerability and safety of Tamoxifen with or without concomitant Zoladex

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
TAM+OFS(E) group	Experimental	Drug: goserelin, Drug: tamoxifenPatients should be premenopausal women ,prior to the start of chemotherapy, less than or equal to 45 years of age with oestrogen receptor positive ± progesterone receptor positive who have undergone a primary mass excision, received an neo-/adjuvant chemotherapy ± radiotherapy for their stage I, II or III breast cancer. This arm is ovarian suppression group which have a various starting time of ovarian function suppression after neo-/adjuvant chemotherapy. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. After that, the patients will complete taking tamoxifen 20mg/day for 5 years.
TAM(D) group	Active comparator	Drug: tamoxifenPatients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 0, 6, 12, 18 and 24 months since the baseline asTsessment(0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. The latter will complete taking tamoxifen 20mg/day for 5 years.
Permanent postmenopausal(A) group	No intervention	–Patients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. Eligible patients except for premenopausal status at the baseline will be followed up until 2 years after the baseline assessment for evaluating the menopausal status. This group still remains to postmenopausal status and will taking tamoxifen 20mg/day for 5 years if they remain in the study.
TAM(B)	Active comparator	Drug: tamoxifenPatients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized into the additional ovarian function suppression group or tamoxifen only group. This group, patients are premenopausal women, they will be randomized into tamoxifen only group, complete taking tamoxifen 20mg/day for 5 years.
TAM+OFS (C)	Experimental	Drug: goserelin, Drug: tamoxifenPatients, less than or equal to 45 years of age with hormone receptor positive breast cancer will be enrolled. Included All the patients have already treated by surgery, neo- or adjuvant chemotherapy ±and/or radiotherapy before enrolment. At 6, 12, 18 and 24 months since the baseline assessment (0), the ovarian function status will be evaluated by menstruation status or serum FSH level. If the patients are regarded as the premenopausal women, they will be randomized. This group, patients are premenopausal women, they will be randomized into the additional ovarian function suppression group. Ovarian function suppression will be done by administration of LHRH agonist (ZOLADEXTM) for 2 years. Then, Patients will complete taking tamoxifen 20mg/day for 5 years.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Patients must have undergone excision of the primary breast mass, proven histologically to be invasive breast adenocarcinoma.
Patients must be within 3 months after the last cycle of chemotherapy.
Patients must have the history of normal menstruation prior to the start of chemotherapy.
Stage I, II or III
Woman, less than or equal to 45 years of age

Key exclusion criteria (10 listed)

Patients whose primary breast cancer was classified as:
Patients with the history of hysterectomy or oophorectomy
Sarcomas or squamous cell carcinomas of the breast are not eligible.
Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
Investigational drugs given within the previous 4 weeks.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
goserelinAlso: Zoladex®1. Zoladex™ administration: Zoladex™ depot is available as a sterile disposable syringe. The depot is administered subcutaneously under the abdominal skin under sterile conditions. If necessary the injection site may be pre-treated with a local anaesthetic. 2. Sequence of administration Zoladex depot: The substance is administered for 24 months (2 years) at 28-day intervals (a period of 34 days between 2 administrations must not be exceeded). 3. Dosage: Each depot contains 3.6mg Zoladex. The substance Zoladex is contained in a while cylindrical rodlet . 4. Storage instructions for Zoladex™ Zoladex™ is kept a room temperature.	Drug	TAM+OFS (C), TAM+OFS(E) group
tamoxifenAlso: Nolvadex1. Dose and period of Tamoxifen therapy: Tamoxifen is administered in tablet form. Each day 2 X 10 mg or 1 X 20 mg Tamoxifen are taken in the form of the respective tablet. 2. Storage instructions for Tamoxifen Tamoxifen is stored at room temperature away from light.	Drug	TAM(B), TAM(D) group, TAM+OFS (C), TAM+OFS(E) group

Primary outcome

all cause recurrence
Time frame: the first 5 years after surgery

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2009.
Derived from this study: PubMed 34010788Kim HJ, Noh WC, Nam SJ, Park BW, Lee ES, Im SA, Jung YS, Yoon JH, Kang SS, Park KH, Lee SJ, Jeong J, Lee MH, Cho SH, Kim SY, Kim HA, Han SH, Han W, Hur MH, Kim S, Ahn SH. Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report. Eur J Cancer. 2021 Jul;151:190-200. doi: 10.1016/j.ejca.2021.03.017. Epub 2021 May 16.
Derived from this study: PubMed 31518174Kim HA, Lee JW, Nam SJ, Park BW, Im SA, Lee ES, Jung YS, Yoon JH, Kang SS, Lee SJ, Park KH, Jeong J, Cho SH, Kim SY, Kim LS, Moon BI, Lee MH, Kim TH, Park C, Jung SH, Gwak G, Kim J, Kang SH, Jin YW, Kim HJ, Han SH, Han W, Hur MH, Noh WC; Korean Breast Cancer Study Group. Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial. J Clin Oncol. 2020 Feb 10;38(5):434-443. doi: 10.1200/JCO.19.00126. Epub 2019 Sep 16.
Derived from this study: PubMed 27197523Kim HA, Ahn SH, Nam SJ, Park S, Ro J, Im SA, Jung YS, Yoon JH, Hur MH, Choi YJ, Lee SJ, Jeong J, Cho SH, Kim SY, Lee MH, Kim LS, Moon BI, Kim TH, Park C, Kim SJ, Jung SH, Park H, Gwak GH, Kang SH, Kim JG, Kim J, Choi SY, Lim CW, Kim D, Yoo Y, Song YJ, Kang YJ, Jung SS, Shin HJ, Lee KJ, Han SH, Lee ES, Han W, Kim HJ, Noh WC. The role of the addition of ovarian suppression to tamoxifen in young women with hormone-sensitive breast cancer who remain premenopausal or regain menstruation after chemotherapy (ASTRRA): study protocol for a randomized controlled trial and progress. BMC Cancer. 2016 May 19;16:319. doi: 10.1186/s12885-016-2354-6.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Woo-Chul Noh, MD.PhD principal investigator

Department of Surgery, Korea Cancer Center Hospital, 215-4 Gongneung-dong, Nowon-gu, Seoul, Korea

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing goserelin and tamoxifen in people with Breast Cancer, run by Korean Breast Cancer Study Group at 1 site in South Korea.

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 10 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 16 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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?

Results are not available in the source record.

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?

all cause recurrence (time frame: the first 5 years after surgery). 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 NCT00912548, which also lists 3 linked publications.

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 16 Jun 2009.