Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study compares two schedules of upfront chemotherapy in HER positive breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Netherlands Cancer Institute
• Collaborators: Borstkanker Onderzoek Groep; Roche Pharma AG
• Treatments: Carboplatin; Cyclophosphamide; Fluorouracil; Paclitaxel; Pertuzumab; Trastuzumab

Criteria

Inclusion Criteria:

• Histologically confirmed infiltrating breast cancer

• Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan.

• Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:

•>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)

•HER2 gene amplification defined as >6 HER2 gene copies per nucleus by in situ hybridization.

• Age ≥18

• Eastern Cooperative Oncology Group performance status ≤1

• 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)

• Adequate renal function (creatinine clearance >50 ml/min)

• LVEF ≥50% measured by echocardiography or MUGA

• Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

• Absence of any medical condition that would place the patient at unusual risk.

• Signed written informed consent

Exclusion Criteria:

• previous radiation therapy or chemotherapy

• other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.

• current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection

• evidence of distant metastases. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures.

• evidence of bilateral infiltrating breast cancer. Evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or MRI breast.

• concurrent anti-cancer treatment or another investigational drug.