Actively Recruiting
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
Led by The Netherlands Cancer Institute · Updated on 2024-01-11
30
Participants Needed
1
Research Sites
645 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.
CONDITIONS
Official Title
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent
- Histologically confirmed primary invasive breast cancer
- Stage II to IIIA primary breast cancer (tumor size ≥ 2 cm and/or lymph node involvement confirmed)
- HER2 overexpression (IHC 3+) on pre-treatment biopsy
- Known estrogen and progesterone receptor status (ER-negative or PR-negative defined as <10% immunoreactive tumor nuclei)
- WHO performance status 0-1
- Age 18 years or older
- Left ventricular ejection fraction (LVEF) 50% or higher
- Eligible for neoadjuvant treatment
- Adequate bone marrow function (ANC ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L)
- Adequate liver function (ALAT, ASAT, and bilirubin ≤ 2.5 times upper limit of normal; Gilbert's syndrome allowed with total bilirubin ≤ 2.5 x ULN if no biliary obstruction)
- Adequate renal function (creatinine clearance > 50 ml/min by Cockcroft-Gault, MDRD, or 24-hour urine collection)
You will not qualify if you...
- Current pregnancy or breastfeeding
- Current or previous other malignancy unless treated without systemic therapy and more than five years ago
- Psychological, familial, sociological, or geographical conditions that may affect compliance
- Use of strong CYP3A4 or CYP2C8 inhibitors or inducers near treatment start
- Known chronic liver disease
- History of inflammatory bowel disease or bowel resection
- Contraindications for MRI
- Inflammatory breast cancer, cT4 and/or cN3 tumors
- Occult breast cancer (cT0)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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