Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose… (NCT07602907) | Clinical Trial Compass
RecruitingPhase 2
Metronomic Oral Paclitaxel Monotherapy for Advanced HER2-Negative Breast Cancer: A Two-Stage Dose-Finding and Expansion Study
China73 participantsStarted 2026-08-04
Plain-language summary
The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary anti-tumor activity of metronomic oral paclitaxel solution in patients with advanced HER2-negative breast cancer who have previously received systemic anti-cancer treatments.
The main questions this study aims to answer are:
What doses of metronomic oral paclitaxel solution can be safely administered to patients with advanced HER2-negative breast cancer? How well does metronomic oral paclitaxel solution control tumor growth? What side effects and treatment-related medical problems occur during treatment?
This study will include two stages. In the first stage, researchers will evaluate different dosing schedules of oral paclitaxel solution to identify a dose（OTD） with an acceptable balance between safety and potential anti-tumor activity. In the second stage, additional participants will receive the selected dose（OTD） to further evaluate its effectiveness and safety.
Participants will:
Receive metronomic oral paclitaxel solution according to the assigned dose schedule.
Visit the study clinic regularly for physical examinations, laboratory tests, tumor imaging assessments, and safety evaluations.
Complete assessments of treatment response, side effects, and quality of life during the study.
Continue follow-up after treatment to collect information about disease status and survival.
Who can participate
Age range
18 Years
Sex
ALL
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
.Age ≥ 18 years, male or female. 2.Histologically confirmed unresectable locally advanced, recurrent, or metastatic HER2-negative breast cancer, regardless of hormone receptor (HR) status. For patients with HR+/HER2-negative subtype: prior treatment with at least 1 line of CDK4/6 inhibitor plus endocrine therapy is required, and the patient is considered no longer suitable for further endocrine therapy by the investigator.
.Patients have received 1-4 prior lines of systemic anti-tumor therapy for recurrent or metastatic disease.
. Line of therapy is defined as a systemic treatment regimen for recurrent or metastatic disease. First-line therapy is the first regimen used in the recurrent/metastatic setting; any subsequent regimen that adds a new drug class (e.g., anti-angiogenic, immunotherapy) is considered a new line.
. Neoadjuvant or adjuvant therapy is not counted as a treatment line.
. Disease recurrence \>6 months after neoadjuvant therapy is counted as first-line; recurrence ≤6 months is considered continuation of prior therapy and not a new line.
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
Optimal Tolerated Dose (OTD) of metronomic oral paclitaxel
Timeframe: TRAE assessment: Within 7 days after the first dose DCR assessment: At the first efficacy evaluation (planned at 6 weeks after the first dose)
2
Disease Control Rate (DCR)
Timeframe: Up to approximately 24 months from the first dose of combination therapy
. Disease recurrence \>12 months after adjuvant therapy is counted as first-line; recurrence ≤12 months is considered continuation of prior therapy, and subsequent regimens start at second-line.
.Prior treatment with taxane is allowed if both criteria are met:
. Interval from last dose of taxane to first study dose ≥ 4 weeks;
Exclusion criteria
. Patients with suspected major infectious diseases, neurological disorders, or intestinal obstruction.
. Patients with a diagnosis of other cancer types (except non-melanoma skin cancer, cervical carcinoma in situ, or other cancers with no recurrence or metastasis for ≥5 years and considered cured).
. Patients who have undergone major surgery, including organ resection within 4 weeks before enrollment, or radiotherapy within 2 weeks before enrollment.
. Disease progression during prior taxane salvage therapy (at least 2 cycles completed), or recurrence/metastasis within 12 months after neoadjuvant/adjuvant therapy.
. Patients requiring long-term concomitant use of P-glycoprotein (P-gp) inhibitors or immunosuppressive agents during the study.
. Patients receiving long-term treatment with steroids or other immunosuppressive agents (except oral, topical, or local injection).
. Patients with myocardial infarction, congestive heart failure, rapidly changing arrhythmia on ECG, severe or unstable angina pectoris, or other serious heart diseases.
. Patients with other severe medical diseases (uncontrolled diabetes mellitus and hypertension, chronic obstructive pulmonary disease (COPD), or dyspnea at rest due to any cause).