T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title: A Phase 1b Study of Talimogene Laherparepvec (T-VEC) in Combination With Chemotherapy or Endocrine Therapy in Patients With Metastatic, Unresectable, or Locoregionally Recurrent HER2-negative Breast Cancer

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the safety and tolerability of intra-lesional talimogene laherparepvec injections in combination with chemotherapy or endocrine therapy in patients with metastatic, unresectable, or locoregionally recurrent HER2-negative breast cancer who have injectable sites of disease.

SECONDARY OBJECTIVES:

To evaluate the efficacy of talimogene laherparepvec in combination with chemotherapy or endocrine therapy in the study population

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT I (CHEMOTHERAPY): Patients receive talimogene laherparepvec intra-tumorally (IT) on day 1 of cycle 1, on days 1 and 15 of cycle 2, on day 8 of cycle 3, then on day 1 of subsequent cycles. Patients also receive paclitaxel or nab-paclitaxel intravenously (IV) over 60 minutes on days 1, 8, and possibly 15, or gemcitabine IV over 30-60 minutes and carboplatin IV over 30-60 minutes on days 1 and 8. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

COHORT II (ENDOCRINE THERAPY): Patients receive talimogene laherparepvec IT every 2 weeks for the first 10 weeks and then every 3 weeks thereafter. Patients also receive letrozole orally (PO), anastrazole PO, exemestane PO, tamoxifen PO on days 1-28 or fulvestrant intramuscularly (IM) every 2 weeks for 3 doses then every 4 weeks for the subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days. ;

Related Conditions & MeSH terms

• Anatomic Stage III Breast Cancer AJCC v8
• Anatomic Stage IIIA Breast Cancer AJCC v8
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Anatomic Stage IV Breast Cancer AJCC v8
• Breast Neoplasms
• Carcinoma
• Estrogen Receptor Positive
• HER2/Neu Negative
• Invasive Breast Carcinoma
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8
• Prognostic Stage IV Breast Cancer AJCC v8
• Recurrent Breast Carcinoma

• NCT number: NCT03554044
• Study type: Interventional
• Source: University of California, San Francisco
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 5, 2020
• Completion date: April 30, 2025