Breast CancerASTRRAIVNCT07735897
Long Term Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women
An observational study of Breast Cancer, run by MedicalExcellence at 1 site in South Korea.
Trial summary
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 1,483 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2026to 1 May 2034
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Premenopausal women with hormone receptor-positive breast cancer who were enrolled and randomized in the ASTRRA trial and received adjuvant endocrine therapy after chemotherapy.
Who may be able to join
- Premenopausal women with hormone receptor-positive breast cancer enrolled in the ASTRRA trial (NCT00912548).
- Patients enrolled and randomized in the ASTRRA study between March 1, 2009, and July 17, 2018 (excluding screening failures).
- Patients with available long-term follow-up information.
Who cannot join
- Patients with primary breast cancer meeting any of the following criteria:
- Hormone receptor-negative breast cancer Unknown hormone receptor status
- Patients with a history of hysterectomy or bilateral oophorectomy
- Patients with breast sarcoma or squamous cell carcinoma of the breast
- Patients with a history of malignancy other than breast cancer within 5 years prior to enrollment
- Patients with thrombocytopenia
- Patients who had previously received CMF chemotherapy (cyclophosphamide, methotrexate, and fluorouracil)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tae-Kyung Yoo, MD contact
South Korea1 site
Asan Medical Center
Seoul, Sondpagu, 05505
Heejeong Kim, MD, 821099762969, heejeong_kim@amc.seoul.kr
Minjung Kim, Master, 821099762969, mj.kim@mediex.co.kr
About this study
Official title: Prospective Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-sensitive Breast Cancer Who Remain Premenopausal or Resume Menstruation After Chemotherapy: ASTRRA- IV Study
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. The study will assess recurrence, breast cancer-specific survival, and overall survival beyond 10 years to determine the long-term benefits of OFS treatment.
Read the detailed description
To evaluate the long-term outcomes beyond 10 years of the Korean Breast Cancer Society-sponsored multicenter prospective ASTRRA trial, we aim to compare the effects of adding 2 years of ovarian function suppression (OFS) therapy to standard tamoxifen treatment in premenopausal young women with hormone receptor-positive breast cancer who preserved or recovered ovarian function after chemotherapy. Given the characteristic pattern of delayed recurrence in hormone receptor-positive breast cancer compared with other molecular subtypes, this long-term follow-up study will assess the durability and safety of the treatment strategy by evaluating disease-free survival (DFS) beyond 10 years, breast cancer-specific survival, and overall survival. In addition, through analyses of recurrence patterns according to treatment groups, we aim to determine the long-term impact of additional OFS therapy on reducing different types of recurrence.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Hormone receptor-positive, Premenopausal breast cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Disease-Free Survival Analysis of the ASTRRA Trial
Long-term Survival Analysis of Premenopausal Young Breast Cancer Patients with Preserved or Recovered Ovarian Function after Chemotherapy Receiving Ovarian Function Suppression Plus Tamoxifen
Measured: 25-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Mar 2034 (estimated)
- Study completion1 May 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,483 participants (estimated)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- MedicalExcellence
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center
- Responsible party
- Sponsor
- Investigators
- heejeong Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735897
- Sponsor's protocol ID
- ASTRRA IV Study
- Acronym
- ASTRRAIV
- Status last verified
- Jul 2026
- First submitted
- 25 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Adding Ovarian Function Suppression to Tamoxifen in Young Women With Hormone-sensitive Breast Cancer Who Remain Premenopausal or Resume Menstruation After Chemotherapy: ASTRRA- IV Study
- ClinicalTrials.gov ID
- NCT07735897
- Acronym / sponsor ID
- ASTRRAIV / ASTRRA IV Study
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Hormone receptor-positive, Premenopausal breast cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,483 participants (estimated)
- Lead sponsor
- MedicalExcellenceUniversity, hospital or other
- Collaborators
- Asan Medical Center
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Mar 2034 (estimated)
- Study completion
- 1 May 2034 (estimated)
- First posted
- 30 Jul 2026 (actual)
- 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.
This study evaluates the long-term effects of adding 2 years of ovarian function suppression (OFS) to tamoxifen therapy in young premenopausal women with hormone receptor-positive breast cancer after chemotherapy. The study will assess recurrence, breast cancer-specific survival, and overall survival beyond 10 years to determine the long-term benefits of OFS treatment.
Detailed description
To evaluate the long-term outcomes beyond 10 years of the Korean Breast Cancer Society-sponsored multicenter prospective ASTRRA trial, we aim to compare the effects of adding 2 years of ovarian function suppression (OFS) therapy to standard tamoxifen treatment in premenopausal young women with hormone receptor-positive breast cancer who preserved or recovered ovarian function after chemotherapy. Given the characteristic pattern of delayed recurrence in hormone receptor-positive breast cancer compared with other molecular subtypes, this long-term follow-up study will assess the durability and safety of the treatment strategy by evaluating disease-free survival (DFS) beyond 10 years, breast cancer-specific survival, and overall survival. In addition, through analyses of recurrence patterns according to treatment groups, we aim to determine the long-term impact of additional OFS therapy on reducing different types of recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 25 Years
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Premenopausal women with hormone receptor-positive breast cancer who were enrolled and randomized in the ASTRRA trial and received adjuvant endocrine therapy after chemotherapy.
Key inclusion criteria (3 listed)
- Premenopausal women with hormone receptor-positive breast cancer enrolled in the ASTRRA trial (NCT00912548).
- Patients enrolled and randomized in the ASTRRA study between March 1, 2009, and July 17, 2018 (excluding screening failures).
- Patients with available long-term follow-up information.
Key exclusion criteria (7 listed)
- Patients with primary breast cancer meeting any of the following criteria:
- Hormone receptor-negative breast cancer Unknown hormone receptor status
- Patients with a history of hysterectomy or bilateral oophorectomy
- Patients with breast sarcoma or squamous cell carcinoma of the breast
- Patients with a history of malignancy other than breast cancer within 5 years prior to enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Long-term Disease-Free Survival Analysis of the ASTRRA Trial
Time frame: 25-year follow-up
Long-term Survival Analysis of Premenopausal Young Breast Cancer Patients with Preserved or Recovered Ovarian Function after Chemotherapy Receiving Ovarian Function Suppression Plus Tamoxifen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Tae-Kyung Yoo, MD contact
heejeong Kim, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by MedicalExcellence 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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 31 Jul 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact heejeong Kim, MD (82-2-3482-7809, heejeong_kim@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term Disease-Free Survival Analysis of the ASTRRA Trial (time frame: 25-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2026.