Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03747120
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Paclitaxel — DRUG
    All subjects will receive Paclitaxel weekly for 12 weeks
  • Trastuzumab — DRUG
    All subjects will receive Trastuzumab every 3 weeks
  • Pertuzumab — DRUG
    Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
  • Pembrolizumab — DRUG
    Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks

Study Details

A phase 2 open-label, randomized, multi-center trial to evaluate the efficacy and safety of neoadjuvant trastuzumab, pertuzumab and weekly paclitaxel (THP) as compared to neoadjuvant trastuzumab, pertuzumab, pembrolizumab and weekly paclitaxel (THP-pembrolizumab), or neoadjuvant trastuzumab, pembrolizumab and weekly paclitaxel (TH-pembrolizumab ) in chemo naive patients with invasive human epidermal growth factor receptor 2 (HER2) positive breast cancer whose primary tumors are \> 2 cm and/or clinically lymph node positive. Treatment will be followed by standard of care breast surgery and physician's choice adjuvant therapy per standard of care.

Key Dates

Start date
Jan 25, 2019
Status verified
Jun 2025
Primary completion
Nov 8, 2024
Completion
Dec 31, 2029

Study Design

Enrollment
138 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A: THP
    Arm A: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
  • Experimental: Arm B: THP-Pembrolizumab
    Arm B: Paclitaxel weekly x12 + Trastuzumab + Pertuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.
  • Experimental: Arm C: TH-Pembrolizumab
    Arm C: Paclitaxel weekly x12 + Trastuzumab + Pembrolizumab All subjects may receive standard of care systemic therapy after surgery per their treating physician's discretion.

Primary Outcome Measure

Pathological Complete Response (pCR) [ Time Frame: 16 weeks from randomization ]

Locations (5)

FacilityCityStateZIPSite coordinators
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Massachusetts General HospitalBostonMassachusetts02114-
New Mexico Cancer CenterAlbuquerqueNew Mexico87109-
Providence Cancer InstitutePortlandOregon97213-
UT Southwestern Medical CenterDallasTexas75006-7541-

Related coverage on Hipa.ai

Find similar trials in Los Angeles, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Cedars Sinai Medical Center· Los Angeles, CAMassachusetts General Hospital· Boston, MANew Mexico Cancer Center· Albuquerque, NMProvidence Cancer Institute· Portland, ORUT Southwestern Medical Center· Dallas, TX

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