Status:
ACTIVE_NOT_RECRUITING
Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
Lead Sponsor:
Borstkanker Onderzoek Groep
Collaborating Sponsors:
Roche Pharma AG
BOOG Study Center
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 (PT...
Detailed Description
High pathological complete response (pCR)-rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II - III breast cancer patients. Tota...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
February 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2032
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT03820063
Start Date
February 27 2019
End Date
May 1 2032
Last Update
September 19 2025
Active Locations (52)
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1
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
2
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
3
Ziekenhuisgroep Twente
Almelo, Netherlands
4
Meander Medisch Centrum
Amersfoort, Netherlands