West Cancer Center

MOLECULARLY TARGETED: HER2 mut/expr: Metastatic; >/= 2nd line; My Pathway-HER2

My Pathway: An open-label Phase IIA study evaluating trastuzumab/pertuzumab, erlotinib, vemurafenib, vismodegib/cobimetinib, alectinib, and atezolizumab in patients who have advanced solid tumors with mutations or gene expression abnormalities predictive of response to one of these agents

Title

Genentech ML28897 HER2

Study Title

Site Link

NC02091141

Malignancy

biliary cancer, cholangiocarcinoma, salivary gland, bladder, transitional cell carcinoma

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

> 2nd line

Investigational Agent

trastuzumab/pertuzumab

Drug Class

anti-HER2 monoclonal antibodies

Ari VanderWalde, MD

Sponsor

Genentech, Inc.

Phase

Phase 2

Status

Closed to Accrual

Key Eligibility Criteria

http://www.clinicaltrials.gov/ct2/show/NCT02091141

Key Eligibility Criteria Details

One of the following malignancies
- Biliary cancer
- Salivary gland cancer
- Bladder cancer
HER2 overexpression or amplification
ECOG PS 0-2
No prior treatment with any HER-2 directed therapy
No active or untreated CNS metastastasis
LVEF must be > or = 50%

Objective

Primary- ORR; Secondary- DCR, PFS, 1-year OS

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 overexpression or amplification

Dosing Frequency

Trastuzumab 6mg/kg IV q3 weeks; Pertuzumab 420mg IV q3 weeks

Control Agents

None

Study Protocol

Randomized