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Could hormone therapy replace chemo for young breast cancer patients?

NCT ID NCT07311122

Disease control Sponsor: Gangnam Severance Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 4,000 women aged 50 or younger with a common type of early breast cancer. Researchers want to see if hormone therapy plus ovarian function suppression works as well as chemotherapy for those with certain genetic test scores. The goal is to find out who can safely skip chemo and use hormone treatment instead.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,000 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study included the patients aged ≤ 50 years with hormone receptor-positive, HER2-negative breast cancer and pathologic nodal stage pN0-1 and those with an Oncotype DX® Recurrence Score (RS) of 11-25 for pN0 and ≤25 for pN1.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed breast cancer. 2. Age ≤50 years at initial diagnosis. 3. Premenopausal at diagnosis, defined as any of the following: A. History of menstruation within 6 months prior to diagnosis. B. Serum FSH \< 30 mIU/mL. C. If criteria A or B are unavailable, women aged ≤50 years are considered premenopausal. 4. Underwent curative-intent breast cancer surgery between January 2012 and December 2021. 5. Pathologic tumor stage pT1-pT3 after surgery. 6. Pathologic nodal stage pN0-pN1 after surgery. 7. Hormone receptor-positive disease by immunohistochemistry (IHC): estrogen receptor (ER) and/or progesterone receptor (PR) positive (≥1% positive cells or Allred score ≥3). 8. HER2-negative disease per ASCO/CAP guidelines: IHC 0 or 1+; if IHC 2+, in situ hybridization (FISH or SISH) negative. 9. Oncotype DX® performed, meeting one of the following Recurrence Score (RS) ranges: A. pN0: RS 11-25. B. pN1: RS ≤25. Exclusion Criteria: 1. Evidence of distant (systemic) metastasis at diagnosis. 2. Postmenopausal status at diagnosis, defined as any of the following: A. Prior bilateral oophorectomy before the breast cancer diagnosis (considered postmenopausal). B. Prior unilateral oophorectomy alone is not considered postmenopausal (classified as premenopausal). C. Bilateral oophorectomy performed after breast cancer surgery for therapeutic purposes is not an exclusion; such patients will be categorized as having received ovarian function suppression (OFS). D. Serum FSH ≥ 30 mIU/mL. 3. Hormone receptor-negative or HER2-positive disease. 4. Insufficient or unclear data regarding the type of adjuvant therapy received. 5. History of another malignancy treated before the breast cancer diagnosis, except for thyroid cancer and non-melanoma skin cancer. 6. Bilateral breast cancer. 7. Receipt of neoadjuvant systemic therapy prior to surgery.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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