Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

Conditions: Breast cancer, HER2 positive, stage II or III
MedDRA version: 18.1Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: PTClassification code 10006200Term: Breast cancer stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: PTClassification code 10006201Term: Breast cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-001863-21-NL

Lead Sponsor: BOOG Study Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>•To identify prognostic and predictive biomarkers for pCR<br>;Primary end point(s): Pathologic complete response ;Timepoint(s) of evaluation of this end point: Continuously

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Recurrence-free, distant metastasis-free, breast cancer specific, and overall survival (time from randomization to event)<br>•Percentage of conservative surgeries carried out<br>•Percentage of patients with grade >2 toxicity (CTCAE v4.03)<br>;Timepoint(s) of evaluation of this end point: Continuously