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Could a simple hormone test spare thousands of women from chemo?

NCT ID NCT07671885

Disease control Sponsor: Tokyo Women's Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Updated 2 times

Summary

This phase 3 trial is testing whether premenopausal women with a common type of breast cancer (HR+/HER2-) can safely skip chemotherapy if their tumor responds well to hormone therapy before surgery. About 950 women will be randomly assigned to either standard surgery first or hormone therapy before surgery. Those whose tumors shrink enough on hormone therapy will receive only more hormone therapy after surgery, avoiding chemo. The goal is to see if this approach is just as effective at preventing cancer from coming back, while reducing the burden of chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aromatase inhibitor and ovarian function suppression (hormone therapy), with or without chemotherapy
What this could lead to
If successful, this could allow many premenopausal women with intermediate-risk breast cancer to avoid chemotherapy and its side effects, relying only on hormone therapy.
What could go wrong
This is a large phase 3 trial, but it is still ongoing. The response-guided approach may not prove as effective as standard care, and some patients might still need chemotherapy.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 950 people

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

Started

Jan 2026

Expected to finish

Jan 2039

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.

Ages

18 years and older

Sex

Female participants only

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. Women aged 18 years or older 2. ECOG PS 0-1 3. HR-positive/HER2-negative breast cancer 4. ER expression ≥ 10% 5. cN0; HG 1: 3 cm\<T≤5 cm, HG 2: 2 cm\<T≤5 cm or HG3: 1 cm\<T≤5 cm cN1; cT\<5 cm and HG 1/HG 2 6. Premenopausal women with spontaneous menses within 12 months 7. No distant metastasis of breast cancer 8. No prior diagnosis of breast cancer. 9. No multiple regions of breast cancer 10. No contralateral breat cancer 11. Adequate organ function Exclusion Criteria: 1. Presence of active double cancer (synchronous malignancy requiring treatment). 2. Ongoing infectious disease requiring systemic therapy. Fever ≥38.0°C at the time of registration. 3. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant. 4. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation. 5. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents. 6. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months. 7. Uncontrolled hypertension. 8. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy. 9. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.) 10. Positive for HIV antibodies (HIV testing is not mandatory.) 11. Presence of interstitial pneumonia, pulmonary fibrosis, or severe emphysema as diagnosed by chest CT.

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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

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    49 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aichi Cancer Center

    RECRUITING

    Nagoya, Japan

  • Akita University Hospita

    RECRUITING

    Akita, Japan

  • Chiba Cancer Center

    RECRUITING

    Chiba, Japan

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, Japan

  • Gunma Prefectural Cancer Center

    RECRUITING

    Ōta-ku, Japan

  • Gunma University Hospital

    RECRUITING

    Maebashi, Japan

  • Hamamatsu University School of Medicine

    NOT_YET_RECRUITING

    Hamamatsu, Japan

  • Hiroshima City North Medical Center Asa Citizens Hospital

    RECRUITING

    Hiroshima, Japan

  • Hiroshima University Hospital

    RECRUITING

    Hiroshima, Japan

  • Hokkaido Cancer Center

    RECRUITING

    Sapporo, Japan

  • Ibaraki Prefectural Central Hospital

    RECRUITING

    Ibaraki, Japan

  • Institute of Science Tokyo Hospital

    RECRUITING

    Tokyo, Japan

  • Kanagawa Cancer Center

    RECRUITING

    Yokohama, Japan

  • Kansai Medical University Hospital

    RECRUITING

    Hirakata, Japan

  • Kindai University Hospital

    RECRUITING

    Sakai, Japan

  • Kitakyushu Municipal Medical Center

    RECRUITING

    Kitakyushu, Japan

  • Kitasato University Hospital

    RECRUITING

    Sagamihara, Japan

  • Mie University Hospital

    RECRUITING

    Tsu, Japan

  • NHO Nagoya Medical Center

    RECRUITING

    Nagoya, Japan

  • Nagoya City University

    RECRUITING

    Nagoya, Japan

  • Nagoya University Hospital

    RECRUITING

    Nagoya, Japan

  • National Cancer Center Hospital

    RECRUITING

    Tokyo, Japan

  • National Cancer Center Hospital East

    RECRUITING

    Kashiwa, Japan

  • National Center for Global Health and Medicine

    RECRUITING

    Tokyo, Japan

  • National Hospital Organization Fukuyama Medical Center

    RECRUITING

    Fukuyama, Japan

  • National Hospital Organization Kure Medical Center

    RECRUITING

    Kure, Japan

  • National Hospital Organization Kyushu Cancer Center

    RECRUITING

    Fukuoka, Japan

  • National Hospital Organization Nagasaki Medical Center

    RECRUITING

    Ōmura, Japan

  • National Hospital Organization Osaka National Hospital

    RECRUITING

    Osaka, Japan

  • National Hospital Organization Shikoku Cancer Center

    RECRUITING

    Matsuyama, Japan

  • National Hospital Organization Tokyo Medical Center

    RECRUITING

    Tokyo, Japan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Japan

  • Osaka International Cancer Institute

    NOT_YET_RECRUITING

    Osaka, Japan

  • Saitama Cancer Center

    RECRUITING

    Saitama, Japan

  • Saitama Medical Center

    RECRUITING

    Kawagoe, Japan

  • Shizuoka Cancer Center

    RECRUITING

    Shizuoka, Japan

  • Shizuoka General Hospital

    RECRUITING

    Shizuoka, Japan

  • Showa Medical University Hospital

    RECRUITING

    Tokyo, Japan

  • Social medical corporation Hakuaikai Sagara Hospital

    RECRUITING

    Kagoshima, Japan

  • St.Luke's International Hospital

    RECRUITING

    Tokyo, Japan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Japan

  • Tohoku University Hospital

    RECRUITING

    Sendai, Japan

  • Tokai University Hospital

    RECRUITING

    Isehara, Japan

  • Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital

    RECRUITING

    Tokyo, Japan

  • Tokyo Women's Medical University Hospital

    NOT_YET_RECRUITING

    Tokyo, Japan

  • Toranomon Hospital

    RECRUITING

    Tokyo, Japan

  • Tsukuba University Hospital

    RECRUITING

    Tsukuba, Japan

  • Yamaguchi University Hospital

    RECRUITING

    Ube, Japan

  • Yao Municipal Hospital

    RECRUITING

    Yao, Japan

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