Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2
TRAIN-2
Optimizing Neoadjuvant Systemic Treatment for HER2 Positive Breast Cancer - the TRAIN-2 Study
1 other identifier
interventional
437
1 country
33
Brief Summary
This study compares two schedules of upfront chemotherapy in HER positive breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Dec 2013
Longer than P75 for phase_3 breast-cancer
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 18, 2013
CompletedFirst Posted
Study publicly available on registry
November 27, 2013
CompletedStudy Start
First participant enrolled
December 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
ExpectedMarch 29, 2024
March 1, 2024
5 years
November 18, 2013
March 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with pathological complete response
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer
at week 30
Secondary Outcomes (2)
Number of patients with grade >2 adverse events as a measure of safety and tolerability
up to week 35
identify prognostic and predictive biomarkers for pCR
within one year after end of treatment
Study Arms (2)
FEC-T +Pertuzumab
ACTIVE COMPARATORFluorouracil; 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
PTC+Pertuzumab
ACTIVE COMPARATORPaclitaxel; 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
Interventions
Cycle repeated every 21 days
Cycle is repeated every 21 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Netherlands Cancer Institutelead
- Roche Pharma AGcollaborator
- Borstkanker Onderzoek Groepcollaborator
Study Sites (33)
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
MCA
Alkmaar, 1815 JD, Netherlands
ZGT
Almelo, 7609 PP, Netherlands
Antoni van Leeuwenhoek
Amsterdam, 1066 CX, Netherlands
AZVU
Amsterdam, 1081 HV, Netherlands
OLVG
Amsterdam, 1090 HM, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, 1940 EB, Netherlands
Amphia ziekenhuis
Breda, 4819 EV, Netherlands
Reinier de Graaf Groep
Delft, 2625 AD, Netherlands
Deventer ziekenhuis
Deventer, 7416 SE, Netherlands
Ziekenhuis Gelderse Vallei
Ede, 6716 RP, Netherlands
Catharina Ziekenhuis
Eindhoven, 5602 ZA, Netherlands
Maxima Medisch Centrum
Eindhoven, 5631 BM, Netherlands
St Anna Geldrop
Geldrop, 5664 EH, Netherlands
Orbis Medisch Centrum
Geleen, 6162 BG, Netherlands
Groene Hart
Gouda, 2803 HH, Netherlands
Kennemer Gasthuis
Haarlem, 2035 RC, Netherlands
Atrium Medisch Centrum Parkstad
Heerlen, 6401 CX, Netherlands
Spaarne ziekenhuis
Hoofddorp, 2134 TM, Netherlands
Westfries Gasthuis
Hoorn, 1624 NP, Netherlands
MCL
Leeuwarden, 8934 AD, Netherlands
LUMC
Leiden, 2300 RC, Netherlands
Diaconessenhuis Meppel
Meppel, 7943 KA, Netherlands
Canisius-Wilhelmina Hospital
Nijmegen, Netherlands
Waterlandziekenhuis
Purmerend, 1441 RN, Netherlands
Vlietland Ziekenhuis
Schiedam, 3100 AE, Netherlands
Haga
The Hague, 2545 CH, Netherlands
Bronovo Ziekenhuis
The Hague, 2597 AX, Netherlands
St. Elisabeth
Tilburg, 5022 GC, Netherlands
Diaconessenhuis Utrecht
Utrecht, 3582 KE, Netherlands
VieCuri Medisch Centrum voor Noord-Limburg
Venlo, Netherlands
Zaans Medisch Centrum
Zaandam, 1502 DV, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Related Publications (2)
van der Voort A, van Ramshorst MS, van Werkhoven ED, Mandjes IA, Kemper I, Vulink AJ, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS. Three-Year Follow-up of Neoadjuvant Chemotherapy With or Without Anthracyclines in the Presence of Dual ERBB2 Blockade in Patients With ERBB2-Positive Breast Cancer: A Secondary Analysis of the TRAIN-2 Randomized, Phase 3 Trial. JAMA Oncol. 2021 Jul 1;7(7):978-984. doi: 10.1001/jamaoncol.2021.1371.
PMID: 34014249DERIVEDvan Ramshorst MS, van der Voort A, van Werkhoven ED, Mandjes IA, Kemper I, Dezentje VO, Oving IM, Honkoop AH, Tick LW, van de Wouw AJ, Mandigers CM, van Warmerdam LJ, Wesseling J, Vrancken Peeters MT, Linn SC, Sonke GS; Dutch Breast Cancer Research Group (BOOG). Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 Dec;19(12):1630-1640. doi: 10.1016/S1470-2045(18)30570-9. Epub 2018 Nov 6.
PMID: 30413379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabe S Sonke, MD
Antoni van Leeuwenhoek, Amsterdam
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 18, 2013
First Posted
November 27, 2013
Study Start
December 1, 2013
Primary Completion
December 1, 2018
Study Completion (Estimated)
December 1, 2030
Last Updated
March 29, 2024
Record last verified: 2024-03