T-VEC With Chemotherapy or Endocrine Therapy in Treating Participants With Metastatic, Unresectable, or Locoregionally Recurrent HER2- Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03554044|
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : December 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: Anastrozole Drug: Exemestane Drug: Fulvestrant Drug: Letrozole Drug: Paclitaxel Biological: Talimogene Laherparepvec Drug: Tamoxifen Drug: Nab paclitaxel Drug: Gemcitabine Drug: Carboplatin||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 5, 2020|
|Estimated Primary Completion Date :||February 28, 2022|
|Estimated Study Completion Date :||February 28, 2022|
Experimental: Cohort I (talimogene laherparepvec, chemotherapy)
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
Biological: Talimogene Laherparepvec
Drug: Nab paclitaxel
Other Name: Abraxane
Other Name: Gemzar
Other Name: Paraplatin
Experimental: Cohort II (talimogene laherparepvec, endocrine therapy)
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
Biological: Talimogene Laherparepvec
Other Name: Nolvadex
- Number of patients with treatment-related toxicities by maximum observed grade [ Time Frame: Up to 2.5 years ]Treatment-related toxicities will be assessed according to NCI CTCAE v4.03, for all patients who receive at least one dose of study treatment. The distribution for the maximum observed grade for each adverse event will be tabulated and reported with 95% confidence interval
- Maximum tolerated volume [ Time Frame: Up to 2.5 years ]The maximum tolerated volume will be the highest volume (up to 4mL) that results in <=1 dose limiting toxicity (DLT) in 6 treated patients for the chemotherapy group. At least 15 patients will be treated in the chemotherapy cohort and at least 6 patients will be treated in the endocrine therapy cohort.
- Overall response rate (ORR) [ Time Frame: Up to 2.5 years ]The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1. Patients with complete response (CR) or partial response (PR) will be counted as having an objective response
- Response duration [ Time Frame: Up to 2.5 years ]Defined as the time from initial response to the first documented tumor progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554044
|Contact: Ivy J Wongemail@example.com|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Ivy Wong 877-827-3222 firstname.lastname@example.org|
|Principal Investigator: Amy J. Chien, MD|
|Principal Investigator:||Amy J Chien, MD||University of California, San Francisco|