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

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.

Conditions

• 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
• 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

Interventions

DRUG

Anastrozole

Given PO

DRUG

Exemestane

Given PO

DRUG

Fulvestrant

Given IM

DRUG

Letrozole

Given PO

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Talimogene Laherparepvec

Given IT

DRUG

Tamoxifen

Given PO

DRUG

Nab paclitaxel

Given IV

DRUG

Gemcitabine

Given IV

DRUG

Carboplatin

Given IV

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Amy J Chien, MD · University of California, San Francisco

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-02-05

Primary Completion

2023-12-31

Completion

2023-12-31

FDA Drug

Yes

Countries

• United States

Study Locations