Abstract OT1-01-05: A phase II study using talimogene laherparepvec as a single agent for inflammatory breast cancer or non-inflammatory breast cancer patients with inoperable local recurrence
Authors: Willey JS , Marx AN , Lim B , Ibrahim NK , Valero V , Mittendorf EA , Reuben JM , Le-Petross HT , Whitman GJ , Krishnamurthy S , Woodward WA , Lucci A , Liu DD , Shen Y , Ueno NT 
Published: February 2018

Abstract
Objective: The primary purpose of the study is to determine the local and systemic antitumor efficacy of talimogene laherparepvec in locally recurrent breast cancer patients with or without distant metastases, as evidenced by improved overall response rates. This will be the first study to use biopsy of distant disease to demonstrate whether systemic immune modulation has antitumor efficacy in breast cancer patients.
BACKGROUND: Patients with locally recurrent breast disease frequently undergo multimodal treatment at the first occurrence of breast cancer, and because local treatment modalities such as surgical intervention and radiation are difficult to add, they subsequently receive systemic therapy. Talimogene laherparepvec (T-VEC) was developed to eliminate solid tumors and has since been considered as a potential treatment option for body surface tumors. In addition to T-VECinjected area, this agent is capable of modifying the immune response with the potential of inhibiting distant metastases. Hence, locally recurrent breast disease could benefit from T-VECregardless of concomitant distant metastases, and may offer a new local treatment option.
Study Design and Treatment Plan: This is a single agent phase II study. Patients with breast cancer who have recurrence of chest wall disease with or without distant metastasis, have at least 1 injectable lesion ≥5 mm in longest diameter or multiple injectable lesions that in aggregate have a longest diameter of ≥ 5 mm, and meet inclusion and exclusion criteria will be eligible to participate in the study. Patient will receive T-VEC via intra-tumoral injection every 2 weeks after the first initial injection (3 weeks).
STATISTICAL METHODS:
Up to 35 patients will be enrolled in the study. The trial will be conducted using a two-stage design and the overall response rate will be estimated accordingly. It is assumed that the talimogene laherparepvec single agent will have a response rate of 20%. A response rate of 5% or lower will be considered treatment failure and the regimen will be rejected under this circumstance.
Status of the study:
Activation Date: Aug 2016. 6 patients have been treated. Enrollment continues.
Sponsor: Amgen
State of Texas appropriation for rare and aggressive breast cancer research.
Citation Format: Willey JS, Marx AN, Lim B, Ibrahim NK, Valero V, Mittendorf EA, Reuben JM, Le-Petross HT, Whitman GJ, Krishnamurthy S, Woodward WA, Lucci A, Liu DD, Shen Y, Ueno NT. A phase II study using talimogene laherparepvec as a single agent for inflammatory breast cancer or non-inflammatory breast cancer patients with inoperable local recurrence [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT1-01-05.