Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study (NCT07739511) | Clinical Trial Compass
RecruitingPhase 1/2
Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
China30 participantsStarted 2026-07-29
Plain-language summary
This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg/m²).
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female, aged 18 to 70 years.
. Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).
. HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.
. Left ventricular ejection fraction (LVEF) ≥ 50%.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
. Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following:
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.
. Blood chemistry: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula.
Exclusion criteria
. History of prior invasive breast cancer.
. Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and/or skin involvement and/or pathological evidence of tumor cells in dermal lymphatics).
. Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.
. Prior systemic therapy for breast cancer.
. History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.
. Participation in another drug or medical device clinical trial within 4 weeks prior to first dose, with receipt of investigational product or device.
. Major surgery within 28 days prior to first dose, or planned major surgery during the study.
. Other malignancy within the past 5 years (except cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ).