Oncolytic Virus + Chemotherapy for Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Antivirals, Immunosuppressants, Live vaccines

Disqualifiers: Metastatic disease, Herpes infections, Immunocompromised, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Hatem Soliman, M.D.

Principal Investigator

H. Lee Moffitt Cancer Center and Research Institute

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with a specific breast cancer type (triple negative, stages T2-3 N0-2). Participants must have no prior invasive breast cancer history, normal organ/marrow function, and measurable disease. They should not be pregnant/nursing or have certain other cancers, uncontrolled illnesses, known active hepatitis B/C infection, or a history of severe herpes simplex virus complications.

Inclusion Criteria

I agree to use birth control during the study.

Ability to understand and the willingness to sign a written informed consent document

My organs and bone marrow are functioning normally.

Exclusion Criteria

I have not received any live vaccines within the last 28 days.

My breast cancer is advanced, has spread, or I have cancer in both breasts.

I have another cancer, but it's either non-melanoma skin cancer or was caught very early.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy to determine the Maximum Tolerated Dose (MTD) and then treatment at MTD

Up to 6 months

Follow-up

Participants are monitored for pathologic complete response rate and recurrence-free survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Paclitaxel
• Talimogene Laherparepvec

Trial Overview The study tests Talimogene Laherparepvec (a modified herpes virus targeting cancer cells) combined with chemotherapy before surgery in triple negative breast cancer patients. The goal is to see if this oncolytic virus can boost the immune system's response to destroy tumor tissue more effectively than chemotherapy alone.

How Is the Trial Designed?

Group I: Talimogene laherparepvec + Chemotherapy Experimental Treatment 2 Interventions

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.

Paclitaxel is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in European Union as Taxol for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Approved in Canada as Paclitaxel for:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer
• Kaposi's sarcoma

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London