T-VEC + Chemotherapy/Endocrine Therapy for Breast Cancer

Overseen By Madeline Tait

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, San Francisco

Must be taking: Chemotherapy, Endocrine therapy

Must not be taking: Antiherpetics, High-dose steroids

Disqualifiers: Autoimmune disease, CNS metastases, others

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

Compensation: Varies

Number of Visits: 22

Duration: Up to 2.5 years

20 Participants Needed

Trial Summary

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.

Research Team

Amy J. Chien, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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:

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Cohort II (talimogene laherparepvec, endocrine therapy) Experimental Treatment 6 Interventions

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

Group II: Cohort I (talimogene laherparepvec, chemotherapy) Experimental Treatment 5 Interventions

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:

Approved in European Union as Arimidex for:

• Breast cancer
• Early breast cancer in postmenopausal women

Approved in United States as Arimidex for:

• 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

Approved in Canada as Arimidex for:

• Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
• Treatment of postmenopausal women with hormone receptor-positive advanced breast cancer

Approved in Japan as Arimidex for:

• Breast cancer

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

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