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T-VEC + Chemotherapy/Endocrine Therapy for Breast Cancer
Study Summary
This trial is testing the combination of talimogene laherparepvec, a biological therapy, with chemotherapy or endocrine therapy in treating patients with HER2-negative breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2014 Phase 3 trial • 31 Patients • NCT01368276Trial Design
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- I am willing to use condoms during and 30 days after treatment.I am allergic to specific cancer drugs but won't be receiving them in this trial.I am on blood thinners that cannot be stopped for injections.I am fully active or can carry out light work.I have an autoimmune disease but haven't needed strong medication for it in the last 2 weeks.I have severe nerve pain or tingling.My organs are working well.I have recovered from previous cancer treatment side effects, or they are minor.My cancer has spread to the lining of my brain and spinal cord.My lesions are not infected or causing significant bleeding.I need regular herpes medication, not just for chemotherapy.I have been treated with a cancer-killing virus before.I agree to avoid close contact with high-risk individuals during and 30 days after my treatment.My breast cancer is confirmed and does not have the HER2 protein.I am a woman who can have children, have a recent negative pregnancy test, and will use birth control during and after the study.I have not had my uterus or both ovaries removed.I have had a menstrual period in the last 12 months.I am 18 or older with HER2-negative breast cancer that has spread or come back.My brain metastases are stable, and I haven't needed steroids for them in over a week.I have a condition or am taking medication that weakens my immune system.I haven't had major surgery or radiation in the last 2 weeks or still have side effects.My breast cancer is ER+ with at least 1% of cells showing ER presence.I have a tumor or lymph node that is at least 1cm big and can be injected with medicine.I am not pregnant or breast-feeding.I am using medications like bisphosphonates or RANKL antibodies, or undergoing ovarian suppression.I am not willing to use birth control during and for 3 months after my treatment.I have previously received a cancer vaccine.It's been over 2 weeks since my last chemotherapy or targeted therapy dose.I have not received a live vaccine in the last 28 days.You currently have a herpes outbreak on your skin or have had serious complications from a herpes infection in the past.I have a history of heart disease, heart failure, or irregular heartbeats.
- Group 1: Cohort II (talimogene laherparepvec, endocrine therapy)
- Group 2: Cohort I (talimogene laherparepvec, chemotherapy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
For what illnesses is Talimogene Laherparepvec commonly prescribed?
"Talimogene Laherparepvec is regularly employed for treating non-Hodgkin's lymphoma. It can also be efficacious in the management of other diseases like advanced stage non-small cell lung cancer, bladder cancer metastasis, and early treatment of malignancies."
To what extent may patients be imperiled by Talimogene Laherparepvec?
"Because of the limited evidence to support Talimogene Laherparepvec's safety and efficacy, our team at Power assessed its risk as a 1 on their scale."
How many participants comprise this clinical trial?
"Correct. According to the information listed on clinicaltrials.gov, this experiment is currently recruiting participants with an initial listing date of February 5th 2020 and a most recent update of December 22nd 2021. The research team are looking for 25 volunteers from one location."
Are participants currently being accepted for this clinical research?
"Affirmative. Clinicaltrials.gov verifies that this medical trial, posted on February 5th 2020, is actively recruiting patients. The study requires 25 subjects from a single site to complete the trial."
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