Oncolytic Virus + Chemotherapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether injecting a modified virus, Talimogene laherparepvec (a changed herpes virus), directly into breast cancer tumors can enhance chemotherapy's effectiveness. The focus is on triple-negative breast cancer, a challenging type to treat, to determine if this virus can help the immune system attack the cancer. The trial tests the safety and effectiveness of this approach when combined with chemotherapy (specifically, Paclitaxel) before surgery. Women with measurable triple-negative breast cancer on scans, who have not had invasive breast cancer before, may be suitable for this study. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on systemic antiviral therapy or chronic immunosuppressants, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that talimogene laherparepvec, or T-VEC, is generally well-tolerated by patients. One study found that the main side effects include local swelling, redness, and flu-like symptoms, which are manageable and not severe. The FDA has already approved T-VEC for treating melanoma, indicating a good safety record.
Paclitaxel, the chemotherapy drug used in this trial, is commonly used in breast cancer treatments. Studies have shown it can cause side effects like hair loss, tiredness, and low blood cell counts. However, these effects are well-known and usually manageable with medical help.
Both treatments have been tested in people before and have shown safety in previous studies. However, treatments can affect people differently. Always discuss any concerns with a doctor before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about combining Talimogene laherparepvec with chemotherapy for breast cancer because it introduces a novel approach to cancer treatment. Most treatments for breast cancer, like traditional chemotherapy, target rapidly dividing cells but can affect healthy cells too. Talimogene laherparepvec is an oncolytic virus, which means it specifically targets and destroys cancer cells while sparing normal cells, potentially reducing side effects. This combination could enhance the cancer-fighting power of chemotherapy by making it more precise, offering hope for more effective and less harmful treatment options.
What evidence suggests that this treatment might be an effective treatment for breast cancer?
Research has shown that Talimogene laherparepvec (T-VEC), one of the treatments in this trial, may help treat triple-negative breast cancer. In one study, 45.9% of patients who received T-VEC responded positively, and 89% remained disease-free two years after treatment. Another study found that T-VEC can alter immune cell types in the body, potentially enhancing the body's ability to fight cancer.
Paclitaxel, the chemotherapy drug used in this trial, effectively treats breast cancer. Research indicates that patients respond well to it and tolerate it effectively. This trial aims to combine Talimogene laherparepvec and Paclitaxel to eliminate cancer cells more effectively than chemotherapy alone.23467Who 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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Talimogene laherparepvec with Neoadjuvant Paclitaxel Chemotherapy to determine the Maximum Tolerated Dose (MTD) and then treatment at MTD
Follow-up
Participants are monitored for pathologic complete response rate and recurrence-free survival
What Are the Treatments Tested in This Trial?
Interventions
- Paclitaxel
- Talimogene Laherparepvec
Paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
Amgen
Industry Sponsor
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