Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer (NCT05403333) | Clinical Trial Compass
UnknownPhase 2
Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
61 participantsStarted 2022-06-10
Plain-language summary
This is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable locally advanced or metastatic breast cancer.
Who can participate
Age range
18 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:
* Signed Informed Consent Form;
* Women aged ≥ 18 years;
* Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:
* The most recent pathology confirmed HER2 negative, defined as HER2 0/1 + by standard immunohistochemical staining (IHC) or HER2 2 + by IHC but negative by in situ hybridization (ISH);
* Patients with locally advanced or locally recurrent disease should be unable to undergo radical surgical resection confirmed by the investigators;
* Eastern Cooperative Oncology Group (ECOG) score \[0-2\] points;
* At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1):
* If there is only bone metastasis, it is required that the bone metastasis lesion contains bone destruction component;
* if there is only pleural effusion, it is required that the pleural effusion is malignant confirmed by pathology
* No more than 2 prior lines of chemotherapy for advanced and/or metastatic disease;
* Prior chemotherapy regimens must have included taxane;
* Patients with hormone receptor positive disease received at least one line of endocrine therapy for metastatic disease (including CDK4/6 inhibitors, everolimus, chidamide and PI3K inhibitors, etc.);
* Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy. with the following exceptions: 1). alopecia; 2). pigmentation;
* Adequate hematological, hepatic and renal functi…
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.