West Cancer Center

BREAST: Adjuvant; HER2+; "BO28407"

A Study of Kadcyla (trastuzumab emtansine) plus Perjeta (pertuzumab) following anthracyclines in comparison with Herceptin (trastuzumab) plus Perjeta and a taxane following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer.

Title

Hoffman-La Roche BO28407

Study Title

Site Link

NCT01966471

Malignancy

Breast, Early Breast Cancer

Stage

Stage 2

Disease Setting

Adjuvant

Line Of Therapy

N/A

Investigational Agent

TDM1 (Kadcyla), pertuzumab (Perjeta)

Drug Class

anti-HER2 antibody, antibody drug conjugate

Lee Schwartzberg, MD

Sponsor

Hoffman-La Roche

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

HER2+_ (by IHC or FISH)

Stage II or III (non-metastatic)
If no nodal disease, must be ER/PR negative
>9 weeks sincedefinitive breast surgery
Negative HBV and HCV serology
LVEF>_55%
No prior tx with anti-HER2 therapy, taxanes, or anthracyclines
No known active liver disease
No significant CV disease

Objective

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 positive

Dosing Frequency

Control Agents

Study Protocol

Randomized