Docetaxel Chemotherapy and Pembrolizumab Plus Interleukin-12 Gene Therapy in Triple Negative Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT04095689
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Docetaxel — DRUG
    Microtubule-targeting drug (inhibits microtubule depolymerization)
  • Pembrolizumab — DRUG
    Programmed cell death-1 (PD-1) inhibitor
  • IL-12 gene therapy — DRUG
    Adenoviral-mediated IL-12

Study Details

The purpose of this research study is to test the safety and effectiveness of docetaxel chemotherapy and pembrolizumab plus adenoviral-mediated interleukin-12 (ADV/IL-12) gene therapy in patients with anthracycline-refractory, triple negative breast cancer (TNBC).

Key Dates

Start date
May 12, 2021
Status verified
Jan 2026
Primary completion
Jun 3, 2024
Completion
Jun 3, 2024

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    docetaxel chemotherapy and pembrolizumab plus IL-12 gene therapy.

Primary Outcome Measure

Pathological Complete Response (pCR) Rate of Docetaxel Chemotherapy and Pembrolizumab Plus IL-12 Gene Therapy [ Time Frame: 18 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Cancer CenterHoustonTexas77030-

Related coverage on Hipa.ai

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Houston Methodist Cancer Center· Houston, TX

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