20 Participants Needed

T-VEC + Chemotherapy/Endocrine Therapy for Breast Cancer

IJ
IO
MT
Overseen ByMadeline Tait
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of California, San Francisco
Must be taking: Chemotherapy, Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase Ib trials studies the side effects and how well talimogene laherparepvec works when given together with chemotherapy or endocrine therapy in treating patients with breast cancer that does not express the human epidermal growth factor receptor 2 (HER2) protein and has spread to other places in the body (metastatic), cannot be removed by surgery (unresectable), or has come back (recurrent). Biological therapies, such as talimogene laherparepvec, use substances made from living organisms that may attack specific tumor cells and stop them from growing or kill them. Chemotherapy drugs, such as nab-paclitaxel, gemcitabine, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Estrogen can cause the growth of breast cancer cells. Drugs used as endocrine therapy, such as letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, may lessen the amount of estrogen made by the body or may may stop the growth of tumor cells by blocking estrogen from connecting to the cancer cells. Giving talimogene laherparepvec with chemotherapy or endocrine therapy may work better in treating patients with HER2-negative breast cancer.

Who Is on the Research Team?

AJ

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

I am fully active or can carry out light work.
My organs are working well.
FCBP are defined as sexually mature women who:
See 10 more

Exclusion Criteria

Patients must not have received an investigational agent within 4 weeks or <= 5 half-lives, whichever is shorter, prior to starting study treatment.
Any significant medical condition, laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
I am willing to use condoms during and 30 days after treatment.
See 21 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive talimogene laherparepvec in combination with chemotherapy or endocrine therapy

Up to 2.5 years
Every 21 or 28 days depending on cohort

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

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?
2Treatment groups
Experimental Treatment
Group I: Cohort II (talimogene laherparepvec, endocrine therapy)Experimental Treatment6 Interventions
Group II: Cohort I (talimogene laherparepvec, chemotherapy)Experimental Treatment5 Interventions

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

🇪🇺
Approved in European Union as Arimidex for:
🇺🇸
Approved in United States as Arimidex for:
🇨🇦
Approved in Canada as Arimidex for:
🇯🇵
Approved in Japan as Arimidex for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

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 profile image

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton profile image

Paul Burton

Amgen

Chief Medical Officer since 2023

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

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security