T-VEC + Chemotherapy/Endocrine Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how talimogene laherparepvec, a biological therapy using substances from living organisms to target cancer cells, works when combined with either chemotherapy or hormone-blocking drugs in patients with a specific type of breast cancer. The focus is on breast cancer that lacks the HER2 protein, has metastasized, cannot be surgically removed, or has recurred. The trial aims to assess the effectiveness of these combined treatments and identify any side effects. It seeks participants with HER2-negative breast cancer that has spread or recurred and who have at least one detectable tumor for treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I have to stop taking my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does mention that there is no required washout period for endocrine therapy. However, you must not have received an investigational agent within 4 weeks or less than 5 half-lives before starting the study treatment, and the last dose of prior chemotherapy must be at least 2 weeks before the first dose of study treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that talimogene laherparepvec (T-VEC) is generally well-tolerated in treatments. The FDA has already approved it for treating melanoma, a type of skin cancer, confirming its safety for humans. Studies indicate that T-VEC's side effects are mostly mild to moderate, with common ones including flu-like symptoms and injection site reactions, such as redness and swelling.
When combined with chemotherapy, patients have found the side effects manageable. The safety data align with expectations for chemotherapy drugs like paclitaxel or gemcitabine, which can cause tiredness, nausea, and hair loss.
For those receiving T-VEC with hormone-blocking drugs, the safety findings are similar. These treatments often cause side effects like hot flashes or joint pain, but they are usually mild.
Overall, the treatment combinations in this trial appear to have a safety profile similar to each treatment on its own. Participants should discuss any concerns with their healthcare providers to fully understand what to expect during the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about talimogene laherparepvec (T-VEC) for breast cancer because it offers a novel approach by using a genetically modified virus to target and destroy cancer cells directly. Unlike standard treatments that often rely on systemic chemotherapy or hormone therapy to manage breast cancer, T-VEC is injected directly into the tumor, which can potentially reduce side effects and enhance precision. Additionally, by combining T-VEC with either chemotherapy or endocrine therapy, there is hope to boost the immune system’s response against cancer, potentially improving outcomes compared to traditional therapies alone.
What evidence suggests that this trial's treatments could be effective for breast cancer?
Research has shown that talimogene laherparepvec (T-VEC) holds promise when combined with chemotherapy and hormone therapy for breast cancer. In this trial, participants will be divided into two cohorts: one receiving T-VEC with chemotherapy and the other with endocrine therapy. Studies have found that T-VEC can significantly alter the makeup of immune cells and is generally well-tolerated by patients. Specifically, about 45.9% of patients with triple-negative breast cancer responded positively to T-VEC treatment, and 89% remained free of the disease two years after treatment. While more research is needed, these findings suggest that T-VEC could be an effective option against HER2-negative breast cancer when combined with chemotherapy or hormone therapy.678910
Who Is on the Research Team?
Amy J. Chien, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
Adults with HER2-negative breast cancer that's spread, can't be surgically removed, or has returned. Participants must not be naturally postmenopausal for at least a year, have no severe immune conditions or recent major treatments, and agree to use effective birth control. Suitable candidates have at least one tumor that can be injected and are in good health as per ECOG standards.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 in combination with chemotherapy or endocrine therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Anastrozole
- Carboplatin
- Exemestane
- Fulvestrant
- Gemcitabine
- Letrozole
- Nab paclitaxel
- Paclitaxel
- Talimogene Laherparepvec
- Tamoxifen
Trial Overview
The trial is testing the effectiveness of talimogene laherparepvec (a biological therapy) combined with either chemotherapy drugs like nab-paclitaxel, gemcitabine, carboplatin or endocrine therapies such as letrozole and tamoxifen in treating advanced HER2-negative breast cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive talimogene laherparepvec intra-tumorally (IT) every 2 weeks for the first 10 weeks and every 3 weeks thereafter along with letrozole PO, anastrazole PO, exemestane PO, tamoxifen PO on days 1-21 or fulvestrant IM every 2 weeks for 3 doses then every 4 weeks for the subsequent courses. Cycles repeat every 28 days until disease progression or unacceptable toxicity
Patients receive talimogene laherparepvec intra-tumorally (IT) every 2 weeks for the first 10 weeks and every 3 weeks thereafter along with one of the following chemotherapies: paclitaxel (IV), nab-paclitaxel IV, or gemcitabine / carboplatin IV. Cycles repeat every 21 days until disease progression or unacceptable toxicity
Anastrozole is already approved in European Union, United States, Canada, Japan for the following indications:
- Breast cancer
- Early breast cancer in postmenopausal women
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
- Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
- Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
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
Citations
Long-term outcomes in triple-negative breast cancers ...
TVEC plus wT-AC demonstrates promising long term outcomes when compared to the more intensive KEYNOTE 522 checkpoint regimen. Additional ...
Phase Ib study of talimogene laherparepvec in combination ...
AEs were reported by 9 (90%) TNBC and 23 (96%) CRC patients, the majority with grade ≥3 [TNBC, 7 (70%); CRC, 13 (54%)], and 1 was fatal [CRC, 1 (4%)]. Evidence ...
Efficacy and tolerability of neoadjuvant therapy with ...
The study showed that T-VEC treatment in BCCs (1) was effective and well tolerated; (2) significantly altered the immune cell composition and ...
Final 5-Year Follow-Up Results Evaluating Neoadjuvant ...
These results demonstrate that neoadjuvant T-VEC plus surgery improves cancer-related outcomes vs surgery alone, with acceptable safety. The ...
5.
oncology-central.com
oncology-central.com/tvec-a-breakthrough-for-triple-negative-breast-cancer-patients/TVEC: a breakthrough for triple-negative breast cancer ...
Of the 37 patients that underwent treatment, 45.9% experienced a response, 89% were disease-free 2 years post-treatment and patients with a ...
6.
aacrjournals.org
aacrjournals.org/cancerres/article/80/4_Supplement/P3-09-19/646792/Abstract-P3-09-19-Preliminary-safety-data-ofAbstract P3-09-19: Preliminary safety data of intrahepatic ...
Preliminary safety data of intrahepatic talimogene laherparepvec and intravenous atezolizumab in patients with triple negative breast cancer [ ...
IMLYGIC® (talimogene laherparepvec) | Patient Information
IMLYGIC® is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors.1,2 There, it multiplies inside the cancer cells and ...
Talimogene Laherparepvec (T-VEC) and Other Oncolytic ...
In this study, bone marrow aspirates from patients with breast cancer were also exposed to the attenuated HSV-1 virus ex vivo and preferential killing of ...
9.
ema.europa.eu
ema.europa.eu/en/documents/product-information/imlygic-epar-product-information_en.pdfImlygic, INN-talimogene laherparepvec
The safety data was consistent with the patients' underlying disease and the known safety profile of talimogene laherparepvec in adults. Reporting of ...
Phase Ib study of talimogene laherparepvec in ...
Safety/efficacy of T-VEC + atezolizumab was explored in patients with triple negative breast cancer or colorectal cancer.
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