Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Netherlands Cancer Institute
RECRUITING
Amsterdam
Time Frame
Start Date: 2023-12-18
Estimated Completion Date: 2036-05
Participants
Target number of participants: 30
Treatments
Experimental: Tucatinib + trastuzumab + pertuzumab
All patients receive neoadjuvant treatment consisting of trastuzumab, pertuzumab and tucatinib. Patients with hormone receptor positive disease receive concurrent endocrine therapy with an aromatase-inhibitor. Premenopausal women are concurrently treated with a LHRH-agonist. In case of functional tumor volume decrease of at least 65% (responders) after the first three cycles, patients continue treatment for six more cycles of the chemotherapy-free regimen. If tumor response is \<65% (non-responders), patients will switch to receive six cycles paclitaxel, carboplatin, trastuzumab and pertuzumab. This is considered non-investigational treatment.
Related Therapeutic Areas
Sponsors
Collaborators: Seagen Inc.
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov

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