Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer (NCT06513364) | Clinical Trial Compass
CompletedPhase 2
Neoadjuvant Chemotherapy With WH002 in Women With HER2-negative Breast Cancer
China40 participantsStarted 2024-09-10
Plain-language summary
The purpose of this study is to compare the safety and efficacy of bi-weekly WH002(Paclitaxel Medium and Long Chain Fat Emulsion Injection,Cholesterol Bound) vs Paclitaxel both followed by bi-weekly Epirubicin and Cyclophosphamide as neoadjuvant treatment in women with HER2-negative 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
. Age ≥ 18 years, female;
. Histologically confirmed, untreated, unilateral primary invasive breast cancer;
. Confirmed as HER2-negative breast cancer based on pathology testing at the research center; simultaneous determination of hormone receptor status (estrogen receptor \[ER\] and progesterone receptor \[PgR\]), tumor grade, and Ki67 value;
. Clinical staging based on imaging assessment meeting any of the following criteria: IIA (T1c, N1; T2, N0), IIB (T2, N1; T3, N0), IIIA-IIIC (T1c-2, N2-3; T3, N1-3; T4, any N);
. Patient agrees to undergo breast cancer surgery after completing neoadjuvant chemotherapy;
. The Eastern Cooperative Oncology Group performance status ≤1;
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
All reported adverse events, serious adverse events and the percentage of drug-related adverse events, serious adverse events during the treatment period.
Timeframe: From the first administration of the medication until 28 days after the breast cancer surgery, or 28 days after the last administration of the medication.
. Essentially normal function of major organs, with laboratory test values during screening conforming to the following standards:
. Echocardiographic assessment: Left Ventricular Ejection Fraction (LVEF) ≥50%;
Exclusion criteria
. Patients with stage IV metastatic breast cancer or those deemed by the investigator as ineligible for curative surgical resection following neoadjuvant therapy;
. Inflammatory breast cancer and bilateral primary breast cancer (including invasive and in situ carcinomas).
. Patients requiring concurrent use of medications that may affect the metabolism of the study drug within 2 weeks prior to enrollment or during the study, such as strong CYP2C8 or CYP3A4 inducers or inhibitors;
. Breast cancer patients who have previously received anti-tumor treatments, including radiotherapy, chemotherapy, endocrine therapy, targeted therapy, immunotherapy, or who have undergone breast surgery (excluding diagnostic biopsy for primary breast cancer);
. Patients who must receive additional anti-tumor therapies other than the investigational product during the study, such as chemotherapy, endocrine therapy, targeted therapy, immunotherapy regimens, or radiotherapy;
. Patients with a history of allergic constitution (excluding mild, asymptomatic seasonal allergies), or known hypersensitivity to taxane drugs/WH002 or its excipients \[e.g., allergy to medications containing polyoxyethylated castor oil (like cyclosporine); or allergy to drugs containing hardened castor oil (such as vitamin injections); or allergy to lipid emulsion-based drugs\], or known allergy to epirubicin, cyclophosphamide, and/or their excipients;
. Patients with severe organ dysfunction (heart, lung, liver, kidney, brain, etc.), or those who have experienced severe cardiovascular events within 6 months prior to dosing, such as myocardial infarction, unstable angina, coronary artery bypass or peripheral arterial bypass graft surgery, congestive heart failure, significant cerebrovascular events (including transient ischemic attacks), or have arrhythmias requiring treatment, confirmed prolongation of QTc interval (≥470ms) upon reassessment, and chronic heart failure patients (NYHA class III and IV); poorly controlled diabetes (fasting blood glucose ≥13.3mmol/L); inadequately controlled hypertension (systolic pressure \>160 mmHg or diastolic pressure \>100 mmHg), etc.;
. Patients who have had or concurrently have other malignant tumors within the past 5 years, excluding those with basal cell or squamous cell carcinoma of the skin treated with curative intent, or cervical carcinoma in situ;