Could a pill help stop breast cancer from spreading after a local return?
NCT ID NCT07190443
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial tests whether adding the drug abemaciclib to standard hormone therapy can prevent breast cancer from coming back or spreading in people whose cancer has returned in the same breast, chest wall, or nearby lymph nodes. About 290 participants will receive either hormone therapy alone or hormone therapy plus abemaciclib for two years. The study also looks at a blood test to detect leftover cancer cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib (a CDK4/6 inhibitor) taken as a pill
- What this could lead to
- If successful, this could establish a new standard treatment to reduce the risk of breast cancer returning or spreading after a local recurrence.
- What could go wrong
- This is a phase 3 trial, but results are not yet known. Adding abemaciclib may cause side effects like diarrhea or low blood cell counts, and it may not improve outcomes compared to endocrine therapy alone.
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 290 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Feb 2035
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: 1. The patient has been diagnosed with the first locoregional recurrence (LRR) after receiving definitive treatment for primary breast cancer. LRR includes one or more of the following: (i) Ipsilateral breast tumor recurrence (ii) Ipsilateral chest wall recurrence (iii) Regional lymph node recurrence 2. At least one LRR lesion must be confirmed by a biopsy, surgical specimen, or cell block from cytology, and must meet all of the following: (i) Pathologically confirmed as invasive breast cancer, or diagnosed as breast cancer in a cytology cell block (in cases where only a cell block is available, the initial primary breast cancer must have been invasive). (ii) Hormone receptor (HR) expression is positive. (iii) HER2 expression is negative. ※ If multiple lesions are pathologically evaluated and any lesion is HR-negative or HER2-positive, the patient is ineligible. 3. No prior diagnosis of distant metastasis of breast cancer. 4. Imaging assessment before registration confirms: No lymph nodes ≥10 mm in short axis No evidence of distant metastasis 5. Age ≥18 years at the time of registration. 6. ECOG Performance Status of 0 or 1. 7. Chemotherapy for LRR is allowed prior to enrollment. 8. The patient does not have bilateral breast cancer. 9. No prior history of treatment with CDK4/6 inhibitors. 10. Written informed consent has been obtained for participation in this clinical trial. Exclusion Criteria: 1. Presence of active double cancer (synchronous malignancy requiring treatment). 2. Ongoing infectious disease requiring systemic therapy. 3. Fever ≥38.0°C at the time of registration. 4. Women who are pregnant, possibly pregnant, within 28 days postpartum, or breastfeeding; men whose partners intend to become pregnant. 5. Psychiatric illness or symptoms that interfere with daily living and may compromise trial participation. 6. Ongoing systemic administration (oral or IV) of steroids equivalent to ≥10 mg/day of prednisolone or other immunosuppressive agents. 7. Unstable angina (developed or worsened within the past 3 weeks) or myocardial infarction within the past 6 months. 8. Uncontrolled hypertension. 9. Uncontrolled diabetes mellitus despite continuous insulin or oral antidiabetic therapy. 10. Positive for HBs antigen or HCV antibodies (Patients positive for HCV antibodies are not excluded if HCV-RNA is undetectable.) 11. Positive for HIV antibodies (HIV testing is not mandatory.) 12. 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.
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
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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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Cancer Institute Hospital of JFCR
RECRUITINGKoto-ku, Tokyo, 135-8550, Japan
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