Clinical trial NCT03554044: T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With HER2- Negative Breast Cancer
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
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
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.
Interventions:
description: Given PO
name: Anastrozole
other_name: Arimidex
ICI-D1033
ZD-1033
type: Drug
description: Given PO
name: Exemestane
other_name: Aromasin
FCE-24304
type: Drug
description: Given IM
name: Fulvestrant
other_name: Faslodex
ICI 182,780
ZD9238
type: Drug
description: Given PO
name: Letrozole
other_name: CGS 20267
Femara
type: Drug
description: Given IV
name: Paclitaxel
other_name: Anzatax
Asotax
Bristaxol
Praxel
Taxol
Taxol Konzentrat
type: Drug
description: Given IT
name: Talimogene Laherparepvec
other_name: ICP34.5-, ICP47-deleted Herpes Simplex Virus 1 (HSV-1) Incorporating the Human GM-CSF Gene
Imlygic
JS1 34.5-hGMCSF 47- pA-
OncoVEXGM-CSF
T-VEC
type: Biological
description: Given PO
name: Tamoxifen
other_name: Nolvadex
type: Drug
description: Given IV
name: Nab paclitaxel
other_name: Abraxane
type: Drug
description: Given IV
name: Gemcitabine
other_name: Gemzar
type: Drug
description: Given IV
name: Carboplatin
other_name: Paraplatin
type: Drug
Study arms:
design_group_description: 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.<br/>Cycles repeat every 21 days until disease progression or unacceptable toxicity
design_group_title: Cohort I (talimogene laherparepvec, chemotherapy)
design_group_type: Experimental
design_group_description: 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.<br/>Cycles repeat every 28 days until disease progression or unacceptable toxicity
design_group_title: Cohort II (talimogene laherparepvec, endocrine therapy)
design_group_type: Experimental
Sponsor: The University of California, San Francisco
Collaborators: Amgen, Inc.
Drug name mappings:
name: 氟维司群
lang: CN
name: Fulvestrant
lang: EN
name: フルベストラント
lang: JP
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: 来曲唑
lang: CN
name: Letrozole
lang: EN
name: レトロゾール
lang: JP
name: 枸橼酸他莫昔芬
lang: CN
name: Tamoxifen Citrate
lang: EN
name: タモキシフェンクエン酸塩
lang: JP
name: 卡铂
lang: CN
name: Carboplatin
lang: EN
name: カルボプラチン
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 紫杉醇
lang: CN
name: Paclitaxel
lang: EN
name: パクリタキセル
lang: JP
name: 依西美坦
lang: CN
name: Exemestane
lang: EN
name: エキセメスタン
lang: JP
name: Talimogene laherparepvec
lang: EN
name: 阿那曲唑
lang: CN
name: Anastrozole
lang: EN
name: アナストロゾール
lang: JP