Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
TRAIN-3
1 other identifier
interventional
462
1 country
52
Brief Summary
This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Feb 2019
Longer than P75 for phase_2 breast-cancer
52 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
January 25, 2019
CompletedFirst Posted
Study publicly available on registry
January 29, 2019
CompletedStudy Start
First participant enrolled
February 27, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2032
ExpectedSeptember 19, 2025
September 1, 2025
3.7 years
January 25, 2019
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event free survival at three years
Number of patients without progression of disease recurrence, second primary or death
3 years
Secondary Outcomes (10)
Overall survival at three years
3 years
Pathologic complete response in breast and axilla
an average of 6 months
Radiologic complete response
an average of 6 months
Number of neoadjuvant chemotherapy cycles administered
an average of 1 year
Number of radical and non-radical resections
an average of 6 months
- +5 more secondary outcomes
Study Arms (1)
PTC-Pz
EXPERIMENTAL* Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 Patients who do not achieve pCR will complete a total of nine cycles taxane-containing chemotherapy followed by 14 cycles of treatment with adjuvant T-DM1.
Interventions
* Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 In case of non pCR; Adjuvant T-DM1, 3.6mg/kg Q 22 days, for 14 cycles.
Eligibility Criteria
You may qualify if:
- Histologically confirmed primairy infiltrating breast cancer.
- Stage II or Ill disease.
- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy.
- Age \<:18
- ECOG Group performance status
- LVEF \>50% measured by echocardiography, MRI or MUGA
- Known HR-status ( in percentages)
You may not qualify if:
- Previous radiation therapy of chemotherapy
- Pregnancy or breastfeeding
- Evidence of distant metastases
- Evidence of bilateral infiltrating breast cancer
- Concurrent anti-cancer treatment or another investigational drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Borstkanker Onderzoek Groeplead
- Roche Pharma AGcollaborator
- BOOG Study Centercollaborator
Study Sites (52)
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands
Ziekenhuis Amstelland
Amstelveen, Netherlands
Amsterdam UMC
Amsterdam, Netherlands
NKI-AVL
Amsterdam, Netherlands
OLVG
Amsterdam, Netherlands
Gelre ziekenhuizen
Apeldoorn, Netherlands
Rijnstate
Arnhem, Netherlands
Rode Kruis Ziekenhuis
Beverwijk, Netherlands
Alexander Monro ziekenhuis
Bilthoven, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
Reinier de Graaf Groep
Delft, Netherlands
Deventer ziekenhuis
Deventer, Netherlands
van Weel Bethesda
Dirksland, Netherlands
Nij Smellinghe
Drachten, Netherlands
Ziekenhuisvoorziening Gelderse Vallei
Ede, Netherlands
Catharina ziekenhuis
Eindhoven, Netherlands
Maxima Medisch Centrum
Eindhoven, Netherlands
Sint Annaziekenhuis
Geldrop, Netherlands
RIVAS Beatrixziekenhuis
Gorinchem, Netherlands
Groene Hart Ziekenhuis
Gouda, Netherlands
Martini ziekenhuis
Groningen, Netherlands
Ziekenhuis St. Jansdal
Harderwijk, Netherlands
Tjongerschans
Heerenveen, Netherlands
Zuyderland Medisch Centrum
Heerlen, Netherlands
Elkerliek ziekenhuis
Helmond, Netherlands
Tergooi
Hilversum, Netherlands
Spaarne Gasthuis
Hoofddorp, Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
MUMC
Maastricht, Netherlands
Sint Antonius ziekenhuis
Nieuwegein, Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, Netherlands
Bernhoven
Oss, Netherlands
Stichting ziekenhuizen West-Friesland en Waterland
Purmerend, Netherlands
Laurentius ziekenhuis
Roermond, Netherlands
Erasmus MC, Universitair Medisch Centrum Rotterdam
Rotterdam, Netherlands
Franciscus Gasthuis en Vlietland
Rotterdam, Netherlands
Ikazia Ziekenhuis
Rotterdam, Netherlands
Maasstadziekenhuis
Rotterdam, Netherlands
ZorgSaam
Terneuzen, Netherlands
Haaglanden MC
The Hague, Netherlands
Haga Ziekenhuis
The Hague, Netherlands
Rivierenland Ziekenhuis
Tiel, Netherlands
Elisabeth TweeSteden ziekenhuis
Tilburg, Netherlands
Diakonessenhuis Utrecht
Utrecht, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
VieCurie Medisch Centrum voor Noord-Limburg
Venlo, Netherlands
SKB Ziekenhuis Winterswijk
Winterswijk, Netherlands
Zaans Medisch Centrum
Zaandam, Netherlands
Isala Klinieken
Zwolle, Netherlands
Related Publications (1)
van der Voort A, Louis FM, van Ramshorst MS, Kessels R, Mandjes IA, Kemper I, Agterof MJ, van der Steeg WA, Heijns JB, van Bekkum ML, Siemerink EJ, Kuijer PM, Scholten A, Wesseling J, Vrancken Peeters MTFD, Mann RM, Sonke GS; Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II-III HER2-positive breast cancer (TRAIN-3): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 May;25(5):603-613. doi: 10.1016/S1470-2045(24)00104-9. Epub 2024 Apr 5.
PMID: 38588682DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
G S Sonke, MD
NKI-AvL
- STUDY DIRECTOR
A E van Leeuwen- Stok, PhD
BOOG Study Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2019
First Posted
January 29, 2019
Study Start
February 27, 2019
Primary Completion
November 15, 2022
Study Completion (Estimated)
May 1, 2032
Last Updated
September 19, 2025
Record last verified: 2025-09