Could 2 years of hormone therapy be enough for some breast cancers?
NCT ID NCT07153757
First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study tests whether a shorter course of hormone therapy (2-3 years) works as well as the standard longer treatment for women with a very low-risk, early-stage breast cancer. About 2,900 women will be randomly assigned to either the shorter or standard treatment. The goal is to see if the shorter option can maintain cancer control while reducing side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- endocrine therapy (hormone-blocking drugs like tamoxifen or aromatase inhibitors)
- What this could lead to
- If successful, this could show that many women with low-risk breast cancer can safely stop hormone therapy after 2-3 years, reducing side effects and improving quality of life.
- What could go wrong
- This is a large phase 3 trial, but it only includes very low-risk patients, so results may not apply to others. There is a small chance that shorter therapy could lead to higher recurrence rates.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 2,934 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Sep 2033
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Females aged 18 years or older; * Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0); * Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%; * Presence of at least one of the following potential low-risk factors: 1)Tumor size ≤1 cm, 2)21-gene recurrence score \<11, 3)Fudan digital pathological subtype classified as SNF1, 4)Age ≥65 years; * ECOG performance status of 0 or 1; * Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria; * Normal major organ function, meeting the following criteria: 1. Hematological: HB ≥90 g/L (no transfusion within 14 days), ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L; 2. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \>50 mL/min (Cockcroft-Gault formula); * Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: * Primary tumor size \>2 cm in maximum diameter and/or axillary lymph node positivity; * Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy; * Prior adjuvant chemotherapy; * Use of CDK4/6 inhibitors in the adjuvant setting; * History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ); * Metastasis at any site; * Pregnancy, lactation, or women of childbearing potential unable to use effective contraception; * Concurrent participation in other clinical trials; * Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF \<50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension; * Severe or uncontrolled infections; * History of drug abuse or psychiatric disorders; * Patients deemed unsuitable for the study by the investigator.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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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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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
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270 Dongan Road, Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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