NCT02779855View on ClinicalTrials.gov

Talimogene Laherparepvec in Combination With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 2, 2017

Primary Completion Date

September 20, 2020

Study Completion Date

February 28, 2026

Conditions
Breast CancerDuctal CarcinomaInvasive Breast CarcinomaInvasive Ductal Breast Carcinoma
Interventions
BIOLOGICAL

Talimogene laherparepvec

Talimogene laherparepvec injection. Phase I: Dose escalation. Phase II: Treatment at Maximum Tolerated Dose (MTD) from Phase I. The MTD dose level is defined as the highest dose level with ≤1 out of 6 patients experiencing a dose limiting toxicity (DLT).

DRUG

Paclitaxel

Paclitaxel chemotherapy infusion. The paclitaxel weekly dose is fixed at 80 mg/m\^2.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

Amgen
All Listed Sponsors
collaborator

Amgen

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER