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 range18 Years
SexFEMALE
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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…