NCT02779855

Brief Summary

The purpose of this study is to determine if an oncolytic virus called Talimogene laherparepvec (a modified herpes simplex 1 virus that can specifically destroy cancer cells while leaving normal cells alone) injected directly into the tumor during chemotherapy prior to surgery can enhance the elimination of triple negative breast cancer tumors. The natural herpes simplex 1 virus typically causes cold sores around the mouth, but the talimogene laherparepvec version of the herpes virus has been changed to prevent it from reproducing in normal tissue. However, it can still attack and break open cancer tissue which is why it is used as a treatment for cancer. It is thought that this virus can also help recruit the participant's immune system to attack the cancer cells during their treatment and possibly destroy the tumor tissue more effectively than chemotherapy alone. This virus is already FDA approved to treat melanoma skin tumors, so investigators want to determine if this virus can achieve a similar benefit in women with triple negative breast tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 breast-cancer

Timeline
Completed

Started May 2017

Longer than P75 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 20, 2016

Completed
12 months until next milestone

Study Start

First participant enrolled

May 2, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 28, 2021

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 26, 2025

Completed
Last Updated

March 10, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

May 19, 2016

Results QC Date

September 1, 2021

Last Update Submit

February 26, 2026

Conditions

Breast CancerDuctal CarcinomaInvasive Breast CarcinomaInvasive Ductal Breast Carcinoma

Keywords

triple negative breast cancer (TNBC)estrogen receptorprogesterone receptorinvasive ductal carcinomabreast cancer tumors

Outcome Measures

Primary Outcomes (2)

  • Phase I: Maximum Tolerated Dose (MTD) / Recommended Phase II Dose (RP2D)

    MTD/RP2D of talimogene laherparepvec administered with neoadjuvant paclitaxel- doxorubicin/cyclophosphamide chemotherapy.

    Up to 6 months

  • Phase II: Percentage of Participants With Pathologic Complete Response Rate (pCR)

    Perceptage of participants with pCR following study treatment, defined as: Disappearance of histopathologic evidence of malignant cells in breast and axillary lymph nodes.

    Up to 36 months

Other Outcomes (2)

  • Recurrence Free Survival Rate

    Up to 5 years follow-up

  • Overall Survival (OS) Rate

    Up to 5 years follow-up

Study Arms (1)

Talimogene laherparepvec + Chemotherapy

EXPERIMENTAL

Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy treatment administration on an outpatient basis. Phase I: Dose Escalation to Determine Maximum Tolerated Dose (MTD). Phase II: Treatment at MTD.

Biological: Talimogene laherparepvecDrug: Paclitaxel

Interventions

Talimogene laherparepvecBIOLOGICAL

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).

Also known as: IMLYGIC™, modified herpes simplex 1 virus
Talimogene laherparepvec + Chemotherapy
PaclitaxelDRUG

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

Also known as: Taxol®
Talimogene laherparepvec + Chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have histologically or cytologically confirmed clinical stage T2-3 N0-2 triple negative (estrogen receptor/progesterone receptor \<1% human epidermal growth factor receptor 2 (HER2) 0-1 by ImmunoHistoChemistry (IHC) or unamplified by fluorescence in situ hybridization (FISH)) invasive ductal carcinoma.
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>20 mm with conventional techniques or as \>10 mm with spiral CT scan. As well, participants must have primary tumor able to be visualized on ultrasound and amenable to direct injection.
  • No prior history of an invasive breast cancer
  • Adults ages 18-70
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Must have normal organ and marrow function as outlined in protocol
  • Sexually active women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
  • Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

  • T4 tumors, known metastatic disease, recurrent disease, inflammatory breast cancer, multicentric disease, and/or synchronous bilateral breast cancer
  • A second active malignancy, exceptions are localized non-melanoma skin cancers or prior in situ carcinoma
  • Receiving any other investigational agents or are unable to be treated with doxorubicin, cyclophosphamide, and paclitaxel.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to talimogene laherparepvec or other agents used in the study
  • Known active or prior herpes simplex virus infections (HSV), prior complications from HSV infections such as encephalitis, or require systemic antiviral therapy at the time of study enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, known active hepatitis B/C infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant or nursing
  • Immunocompromised patients may be at increased risk of herpetic infections when treated with talimogene laherparepvec. Therefore, HIV-positive patients, patients with acquired or congenital immunodeficiency conditions, those on chronic systemic immunosuppressants (requiring \> 10 mg of prednisone or equivalent/day), Those with active autoimmune disease are excluded from the study.
  • Have received any live vaccine therapies used for the prevention of infectious disease within 28 days prior to enrollment and during treatment period. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed. However, intranasal influenza vaccines (eg, Flu - Mist®) are live attenuated vaccines, and are not allowed.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

  • Soliman H, Hogue D, Han H, Mooney B, Costa R, Lee MC, Niell B, Williams A, Chau A, Falcon S, Soyano A, Armaghani A, Khakpour N, Weinfurtner RJ, Hoover S, Kiluk J, Laronga C, Rosa M, Khong H, Czerniecki B. Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial. Nat Med. 2023 Feb;29(2):450-457. doi: 10.1038/s41591-023-02210-0. Epub 2023 Feb 9.

    PMID: 36759673DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, DuctalCarcinoma, Ductal, BreastTriple Negative Breast Neoplasms

Interventions

talimogene laherparepvecPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
Hatem Soliman, MD
Organization
Moffitt Cancer Center
hatem.soliman@moffitt.org
813-745-4985

Study Officials

  • Hatem Soliman, M.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 20, 2016

Study Start

May 2, 2017

Primary Completion

September 20, 2020

Study Completion

August 26, 2025

Last Updated

March 10, 2026

Results First Posted

October 28, 2021

Record last verified: 2026-02

Locations

US(1)