Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study

NCT07739511 | Not Yet Recruiting Phase 1

• 1 other identifier: OT-2025-004
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

HER2 + Breast Cancer

Keywords

BF-BOIN; Oral paclitaxel; Neoadjuvant Therapy; HER2 positive; Breast cancer

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose(MTD)

  The incidence of dose-limiting toxicitys and any AEs will be assessed. After the trial is completed, the MTD is determined with all the data based on isotonic regression by the shiny app "BF-BOIN" available at http://www.trialdesign.org.

  Up to 24 weeks.

Secondary Outcomes (2)

• total Pathological Complete Response(tpCR)

  Up to six months.

• Overall Response Rate(ORR)

  Up to 24 weeks.

Study Arms (3)

Dose-level 1 cohort

EXPERIMENTAL

The dose of paclitaxel oral solution is 125mg/m2.

Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab

Dose-level 2 cohort

EXPERIMENTAL

The dose of paclitaxel oral solution is 150mg/m2.

Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab

Dose-level 3 cohort

EXPERIMENTAL

The dose of paclitaxel oral solution is 175mg/m2.

Combination Product: Paclitaxel oral solution plus Trastuzumab and Pertuzumab

Interventions

Paclitaxel oral solution plus Trastuzumab and Pertuzumab COMBINATION_PRODUCT

Eligible patients in three cohorts receive 6 neoadjuvant THP cycles: paclitaxel oral solution at 125/150/175 mg/m² BID (D1, D8, D15), and dual anti-HER2 therapy - trastuzumab (8→6 mg/kg IV or 600 mg SC) and pertuzumab (840→420 mg IV), both Q3W - or, alternatively, the pertuzumab/trastuzumab SC fixed-dose combination (Phesgo; loading 1200/600 mg \[15 mL\], maintenance 600/600 mg \[10 mL\]), Q3W; all for 6 cycles.

Also known as: THP regemin

Dose-level 1 cohort; Dose-level 2 cohort; Dose-level 3 cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; platelet count (PLT) ≥ 100 × 10⁹/L; hemoglobin (Hb) ≥ 90 g/L.
• 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.
• Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.

You may not qualify if:

• 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).
• Active tuberculosis or other serious infectious disease, including but not limited to bacteremia, severe infectious pneumonia, or other severe infection requiring systemic therapy.
• History of immunodeficiency or other autoimmune disease, including but not limited to HIV infection (positive HIV antibody), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.
• History of any of the following cardiovascular/cerebrovascular diseases: (1) unstable angina; (2) clinically significant or medication-requiring arrhythmia; (3) myocardial infarction within 6 months; (4) heart failure, or second-degree or higher atrioventricular block; (5) cerebral infarction (except lacunar infarction) or cerebral hemorrhage within 6 months.
• Uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg despite regular antihypertensive medication), or history of hypertensive crisis or hypertensive encephalopathy.
• Uncontrolled concurrent illness or condition (including significant psychiatric or social condition) that, in the investigator's judgment, may affect compliance with study procedures.
• Requirement for long-term use of proton pump inhibitors or H2 receptor antagonists during the study; or use of strong inducers or inhibitors of CYP3A4 or CYP2C8 within 2 weeks prior to first study-drug administration.
• In the investigator's judgment, subjects unsuitable or unwilling to take oral study drug: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal disease; (2) diagnosed disease that may affect administration, gastrointestinal transit, or absorption of the study drug, or adherence to oral study drug, including intestinal obstruction and inflammatory bowel disease (Crohn's disease and ulcerative colitis), peptic ulcer, uncontrolled nausea, vomiting, or diarrhea; (3) presence or suspected impairment of bile secretion.

Sponsors & Collaborators

• Liu Shu: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Trastuzumab; pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Shu Liu, PhD

CONTACT

86- 13908516963; Drliushu@163.com

Yu Ren, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: July 31, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 30, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share