Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer (NCT07333937) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+/HER2+ Advanced Breast Cancer
35 participantsStarted 2025-12-20
Plain-language summary
This study aims to explore the efficacy and safety of neratinib combined with fulvestrant and eribulin in the treatment of HR+/HER2+ advanced breast cancer after trastuzumab deruxtecan resistance. The treatment regimen of neratinib + fulvestrant + eribulin in this study is expected to provide a new and effective therapeutic strategy for patients with triple-positive breast cancer who develop resistance to trastuzumab deruxtecan, and offer novel therapeutic insights for advanced triple-positive breast cancer.
Who can participate
Age range
18 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged ≥18 years and ≤75 years;
* ECOG performance status of 0-2;
* Histologically confirmed HR-positive/HER2-positive advanced breast cancer:
* Definition of HER2 positivity: IHC 3+ or IHC 2+/ISH positive prior to T-DXd treatment;
* Definition of HR positivity: ER or PR ≥1%;
* Refractory to prior treatment containing T-DXd (definition of resistance: a. Definite disease progression per RECIST v1.1 criteria; b. Intolerance to T-DXd treatment);
* Prior exposure to anthracyclines and taxanes (including use in the adjuvant/neoadjuvant setting);
* Presence of at least one measurable lesion (per RECIST v1.1 criteria);
* Estimated survival time ≥3 months;
* Adequate function of major organs, meeting the following requirements (no blood transfusion, no use of leukocyte- or platelet-stimulating agents within 2 weeks prior to screening);
* For premenopausal or non-surgically sterilized female patients: Agreement to abstain from sexual activity or use effective contraceptive methods during treatment and for at least 7 months after the last dose of study treatment;
* Voluntary participation in the study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.
Exclusion Criteria:
* Severe allergic reactions to neratinib, eribulin, fulvestrant, or any of their excipients;
* Prior treatment with neratinib, other small-molecule anti-HER2 TKIs, or eribulin;
* Patients with inflammatory breast cancer;
* A histor…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate(ORR)
Timeframe: From treatment initiation to disease progression, intolerable toxicity, or study completion, whichever occurs first，assessed up to 10 months
Trial details
NCT IDNCT07333937
SponsorXijing Hospital
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-11-20
Contact for this trial
Ethics Committee of the First Affiliated Hospital of Air Force