Breast cancer, HER2 positive, stage II or III MedDRA version: 18.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10006200 Term: Breast cancer stage II System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.1 Level: PT Classification code 10006201 Term: Bre
Conditions
Interventions
Trade Name: Herceptin
Product Name: Herceptin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Current Sponsor code: NA
Other descrip
Sponsors
BOOG Study Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed infiltrating breast cancer. 2. Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. 3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions: • >10% 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. 4. Age =18 5. Eastern Cooperative Oncology Group performance status =1 6. LVEF =50% measured by echocardiography or MUGA Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 144
Exclusion criteria
Exclusion criteria: 1. Previous radiation therapy or chemotherapy 2. Pregnancy, breast feeding 3. Evidence of distant metastases. 4. Evidence of bilateral infiltrating breast cancer 5. Concurrent anti-cancer treatment or another investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer;Secondary Objective: • To describe the safety of the various regimens • To identify prognostic and predictive biomarkers for pCR ;Primary end point(s): Pathologic complete response ;Timepoint(s) of evaluation of this end point: Continuously | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Recurrence-free, distant metastasis-free, breast cancer specific, and overall survival (time from randomization to event) • Percentage of conservative surgeries carried out • Percentage of patients with grade >2 toxicity (CTCAE v4.03) ;Timepoint(s) of evaluation of this end point: Continuously | — |
Countries
Netherlands
Contacts
Public ContactDr. G.S. Sonke
Antoni van Leeuwenhoek Hospital - Netharlands Cancer Institute
Outcome results
None listed