NCT03554044

T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Completed Phase 1 Last updated 21 May 2025

What this trial tests

Phase 1 trial testing Anastrozole in Anatomic Stage III Breast Cancer AJCC v8 in 20 participants. Completed in 31 December 2023.

Timeline

5 February 2020

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	5 February 2020
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across United States

Drugs / interventions tested

• Anastrozole
• Exemestane
• Fulvestrant (fulvestrant) — full drug profile →
• Letrozole — full drug profile →
• Paclitaxel — full drug profile →
• Talimogene Laherparepvec
• Tamoxifen
• Nab paclitaxel
• Gemcitabine
• Carboplatin

Conditions studied

• Anatomic Stage III Breast Cancer AJCC v8 — all drugs for Anatomic Stage III Breast Cancer AJCC v8 →
• Anatomic Stage IIIA Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIA Breast Cancer AJCC v8 →
• Anatomic Stage IIIB Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIB Breast Cancer AJCC v8 →
• Anatomic Stage IIIC Breast Cancer AJCC v8 — all drugs for Anatomic Stage IIIC Breast Cancer AJCC v8 →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with Anatomic Stage III Breast Cancer AJCC v8 or Anatomic Stage IIIA Breast Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with chemotherapy or endocrine therapy in treating patients with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with chemotherapy or endocrine therapy may work better in treating patients with HER2-negative breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Oncolytic Herpes Simplex Virus-Based Therapies for Cancer.
   Aldrak N, Alsaab S, Algethami A, Bhere D, et al · · 2021 · cited 61× · PMID 34207386 · DOI 10.3390/cells10061541
2. HSV-1 Oncolytic Viruses from Bench to Bedside: An Overview of Current Clinical Trials.
   Koch MS, Lawler SE, Chiocca EA. · · 2020 · cited 49× · PMID 33255871 · DOI 10.3390/cancers12123514
3. Targeting Myeloid Cells in Combination Treatments for Glioma and Other Tumors.
   Ding AS, Routkevitch D, Jackson C, Lim M. · · 2019 · cited 47× · PMID 31396227 · DOI 10.3389/fimmu.2019.01715
4. Emerging treatment strategies for metastatic triple-negative breast cancer.
   Huppert LA, Gumusay O, Rugo HS. · · 2022 · cited 28× · PMID 35422881 · DOI 10.1177/17588359221086916
5. Herpes simplex virus 1 as an oncolytic viral therapy for refractory cancers.
   Scanlan H, Coffman Z, Bettencourt J, Shipley T, et al · · 2022 · cited 24× · PMID 35965554 · DOI 10.3389/fonc.2022.940019
6. Cytokine-armed oncolytic herpes simplex viruses: a game-changer in cancer immunotherapy?
   Wang H, Borlongan M, Kaufman HL, Le U, et al · · 2024 · cited 18× · PMID 38821716 · DOI 10.1136/jitc-2023-008025
7. NF-κB Signaling in Targeting Tumor Cells by Oncolytic Viruses-Therapeutic Perspectives.
   Struzik J, Szulc-Dąbrowska L. · · 2018 · cited 18× · PMID 30413032 · DOI 10.3390/cancers10110426
8. Prospect of Plasmacytoid Dendritic Cells in Enhancing Anti-Tumor Immunity of Oncolytic Herpes Viruses.
   Schuster P, Lindner G, Thomann S, Haferkamp S, et al · · 2019 · cited 14× · PMID 31083559 · DOI 10.3390/cancers11050651