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Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2

NCT01996267

Active Not RecruitingPhase 3

Sponsor: The Netherlands Cancer Institute

Conditions: Breast Cancer, HER2 Positive

Interventions: PTC+Pertuzumab, FEC-T+Pertuzumab

Countries: Netherlands

This study compares two schedules of upfront chemotherapy in HER positive breast cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (33)

's-Hertogenbosch, Netherlands
Alkmaar, Netherlands
Almelo, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Amsterdam, Netherlands
Beverwijk, Netherlands
Breda, Netherlands
Delft, Netherlands
Deventer, Netherlands
Ede, Netherlands
Eindhoven, Netherlands
Eindhoven, Netherlands
Geldrop, Netherlands
Geleen, Netherlands
Gouda, Netherlands
Haarlem, Netherlands
Heerlen, Netherlands
Hoofddorp, Netherlands
Hoorn, Netherlands
Leeuwarden, Netherlands
Leiden, Netherlands
Meppel, Netherlands
Nijmegen, Netherlands
Purmerend, Netherlands
Schiedam, Netherlands
The Hague, Netherlands
The Hague, Netherlands
Tilburg, Netherlands
Utrecht, Netherlands
+ 3 more on CT.gov