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Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study

NCT03820063

Active Not RecruitingPhase 2

Sponsor: Borstkanker Onderzoek Groep

Conditions: Breast Cancer

Interventions: PTC-Pz

Countries: Netherlands

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (52)

's-Hertogenbosch, Netherlands
Alkmaar, Netherlands
Almelo, Netherlands
Amersfoort, Netherlands
Amstelveen, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Apeldoorn, Netherlands
Arnhem, Netherlands
Beverwijk, Netherlands
Bilthoven, Netherlands
Breda, Netherlands
Delft, Netherlands
Deventer, Netherlands
Dirksland, Netherlands
Drachten, Netherlands
Ede, Netherlands
Eindhoven, Netherlands
Eindhoven, Netherlands
Geldrop, Netherlands
Gorinchem, Netherlands
Gouda, Netherlands
Groningen, Netherlands
Harderwijk, Netherlands
Heerenveen, Netherlands
Heerlen, Netherlands
Helmond, Netherlands
Hilversum, Netherlands
Hoofddorp, Netherlands
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