Breast Cancer Clinical Trial
— TRAIN-3Official title:
Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
Verified date | February 2023 |
Source | Borstkanker Onderzoek Groep |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 462 |
Est. completion date | May 1, 2032 |
Est. primary completion date | November 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Histologically confirmed primairy infiltrating breast cancer. 2. Stage II or Ill disease. 3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. 4. Age <:18 5. ECOG Group performance status 6. LVEF >50% measured by echocardiography, MRI or MUGA 7. Known HR-status ( in percentages) Exclusion Criteria: 1. Previous radiation therapy of chemotherapy 2. Pregnancy or breastfeeding 3. Evidence of distant metastases 4. Evidence of bilateral infiltrating breast cancer 5. Concurrent anti-cancer treatment or another investigational drug |
Country | Name | City | State |
---|---|---|---|
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 | Jeroen Bosch Ziekenhuis | Den Bosch | |
Netherlands | Haaglanden MC | Den Haag | |
Netherlands | Haga Ziekenhuis | Den Haag | |
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 | 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 |
Lead Sponsor | Collaborator |
---|---|
Borstkanker Onderzoek Groep | BOOG Study Center, Roche Pharma AG |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Event free survival at three years | Number of patients without progression of disease recurrence, second primary or death | 3 years | |
Secondary | Overall survival at three years | Number of patients alive at three years | 3 years | |
Secondary | Pathologic complete response in breast and axilla | Number of patients with absence of invasive tumor cells in breast and axilla at surgery | an average of 6 months | |
Secondary | Radiologic complete response | Number of patients with absence of pathologic enhancement on MRI | an average of 6 months | |
Secondary | Number of neoadjuvant chemotherapy cycles administered | Number of neoadjuvant chemotherapy cycles administered per patient | an average of 1 year | |
Secondary | Number of radical and non-radical resections | Number of patients with radical and non-radical resections | an average of 6 months | |
Secondary | Incidence and severity of adverse events | Number of patients with toxicity grade >= 3 (CTCAE v5.0) until 30 days after last adjuvant administration | an average of 1 year | |
Secondary | Incidence and severity of cardiotoxicity and neuropathy | Number of patients with cardiotoxicity and neuropathy grade >= 2 (CTCAE v5.0) until 30 days after last adjuvant administration | an average of 1 year | |
Secondary | Incidence of symptomatic LVSD (heart failure), | Number of patients with an asymptomatic decline in LVEF requiring treatment or leading to discontinuation of pertuzumab and Herceptin, or a decrease =10 percentage points from baseline to a LVEF <50% | an average of 1 year | |
Secondary | Grade =3 laboratory test abnormalities | Number of patients with Grade =3 laboratory test abnormalities | an average of 1 year | |
Secondary | Incidence of number of tumor positive Vacuum Assisted Core Biopsy | Number of patients with tumor present at Vacuum Assisted Core Biopsy at the moment of radiological complete response on MRI | an average 6 months |
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