Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2 (TRAIN-2)
Breast Cancer, HER2 Positive
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring neoadjuvant, breast cancer, HER2 positive
Eligibility 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.
Sites / Locations
- MCA
- ZGT
- Antoni van Leeuwenhoek
- AZVU
- OLVG
- Rode Kruis Ziekenhuis
- Amphia ziekenhuis
- Reinier de Graaf Groep
- Jeroen Bosch Hospital
- Haga
- Bronovo Ziekenhuis
- Deventer ziekenhuis
- Ziekenhuis Gelderse Vallei
- Catharina Ziekenhuis
- Maxima Medisch Centrum
- St Anna Geldrop
- Orbis Medisch Centrum
- Groene Hart
- Kennemer Gasthuis
- Atrium Medisch Centrum Parkstad
- Spaarne ziekenhuis
- Westfries Gasthuis
- MCL
- LUMC
- Diaconessenhuis Meppel
- Canisius-Wilhelmina Hospital
- Waterlandziekenhuis
- Vlietland Ziekenhuis
- St. Elisabeth
- Diaconessenhuis Utrecht
- VieCuri Medisch Centrum voor Noord-Limburg
- Zaans Medisch Centrum
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
FEC-T +Pertuzumab
PTC+Pertuzumab
Fluorouracil; 500 mg/m2; day 1 Epirubicine; 90 mg/m2; day 1 Cyclophosphamide; 500 mg/m2; day 1 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg) Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle is repeated every 21 days
Paclitaxel; 80 mg/m2; day 1,8 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg); day 1 Carboplatin; AUC=6; day 1 Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle repeated every 21 days