Status:
RECRUITING
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Seagen Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
High pathological complete response (pCR)-rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II - III breast cancer patients. Howe...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Histologically confirmed primary invasive breast cancer
- Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
- HER2 overexpression defined as circumferential membrane staining that is complete, intense and in \>10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
- Known estrogen- and progesterone-receptor expression of the invasive tumor
- a. ER-negative or PR-negative is defined as \<10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR
- WHO performance status 0-1
- Age ≥ 18 years
- LVEF ≥50% measured by echocardiography or MUGA
- Eligible for neoadjuvant treatment
- Laboratory requirements within 21 days prior to enrollment:
- Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l);
- Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists.
- Adequate renal function: creatinine clearance \>50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement.
Exclusion
- 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 condition potentially hampering compliance with the study protocol and follow-up schedule
- Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to first dose of study treatment
- 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)
Key Trial Info
Start Date :
December 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2036
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06162559
Start Date
December 18 2023
End Date
May 1 2036
Last Update
January 11 2024
Active Locations (1)
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1
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX