eoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2-positive breast cancer: the TRAIN-4 study

• Conditions: Breast cancer; HER2-positive breast cancer; 10006291

• Registration Number: NL-OMON53609
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Signed written informed consent 2. Histologically confirmed primary invasive
breast cancer 3. Stage II - IIIA primary breast cancer according to TNM-staging
(8th edition, AJCC); (largest tumor diameter DCE-MRI >= 2cm (cT2-3) and/or cN1-2
confirmed with FNA or histology) 4. HER2 overexpression defined as
circumferential membrane staining that is complete, intense and in >10% of
invasive tumor cells (IHC 3+) on pre-treatment biopsy 5. 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 6. WHO performance status 0-1 7. Age (>= 18 years of age) 8. LVEF >=50%
measured by echocardiography or MUGA 9. Eligible for neoadjuvant treatment 10.
Laboratory requirements within 21 days prior to enrollment: a. Adequate bone
marrow function (ANC >=1.5 x 109/l, platelets >=100 x 109/l); b. 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; c. 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 Criteria

1. Current pregnancy or breastfeeding
2. Current or previous other malignancy unless treated without systemic therapy
and more than five years ago
3. Psychological, familial, sociological, or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule
4. 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
5. Known chronic liver disease
6. History of inflammatory bowel disease or bowel resection
7. Contraindications for MRI
8. Inflammatory breast cancer, cT4 and/or cN3 tumors
9. Occult breast cancer (cT0)

Study & Design

• Study Type: Interventional
• Study Design: Not specified