Clinical trial for HER2 + Breast Cancer
Official title Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study
ClinicalTrials.gov ID: NCT07739511
What this study is testing
What is Paclitaxel oral solution plus Trastuzumab and Pertuzumab?
Paclitaxel oral solution plus Trastuzumab and Pertuzumab is an investigational medicine, being studied as a potential treatment for her2 + breast cancer.
Also referred to as THP regemin.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join if
- Female, aged 18 to 70 years.
- Histologically confirmed invasive breast cancer by core needle biopsy
- 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.
You likely can't join 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...
- 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.
See the full eligibility 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.
- 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
- Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.
- 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
- 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, people unsuitable or unwilling to take oral study drug: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal disease
- Pregnant or lactating women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception throughout the study and for 3 months after the last dose.
- Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.
The study team makes the final eligibility decision.
Where it is enrolling
- Guiyang, Guizhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guiyang, Guizhou, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.