Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01875666
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Trastuzumab — DRUG
    8 mg/kg IV, single dose
  • pertuzumab — DRUG
    840 mg IV single dose
  • lapatinib — DRUG
    1000 mg daily for 7 days

Study Details

Kinases are a group of proteins that are important in how cancer cells grow. HER2 is a kind of kinase. This study looks at a new approach to identifying kinases, which may help target therapy more precisely. LCCC1214 is a randomized, multiarm, multicenter, open-label window trial designed to explore the kinome response in Stage I-IV HER2 positive (HER2+) breast cancer patients scheduled to undergo definitive surgery (either lumpectomy, mastectomy or surgical resection of oligometastatic disease). Patients will initiate dosing with either a single HER2-directed agent or a combination of two HER2-directed agents, one week prior to surgery. Forty patients will be randomized to one of four study groups: A) single dose trastuzumab; B) single dose pertuzumab; C) combination single dose trastuzumab plus single dose pertuzumab; or D) combination single dose trastuzumab plus lapatinib daily for 7 days. Pre- and post- dosing tissue will be analyzed for kinome response and resistant signatures. The initiation of study drug will be defined by the surgical schedule; there will be no delays in standard treatment for the purposes of this study.

Key Dates

Start date
Aug 5, 2013
Status verified
Jul 2020
Primary completion
Dec 19, 2016
Completion
Dec 19, 2016

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Trastuzumab
    single dose intravenous infusion administration of trastuzumab (8 mg/kg)
  • Active Comparator: pertuzumab
    single dose infusion of pertuzumab (840 mg)
  • Active Comparator: trastuzumab plus pertuzumab
    single dose infusion of combination trastuzumab (8 mg/kg) plus pertuzumab (840 mg)
  • Active Comparator: trastuzumab plus lapatinib
    combination of single dose infusion of trastuzumab (8 mg/kg) plus oral lapatinib (1000 mg daily for 7 days)

Primary Outcome Measure

difference in kinome activation pre and post treatment [ Time Frame: 7-10 days prior to surgery and at surgery ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
IU Simon Cancer CenterIndianapolisIndiana46202-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Lineberger Comprehensive Cancer Center, UNCChapel HillNorth Carolina27599-
MD AndersonHoustonTexas77030-4008-

Find similar trials in Birmingham, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Alabama at Birmingham· Birmingham, ALIU Simon Cancer Center· Indianapolis, INDana Farber Cancer Institute· Boston, MALineberger Comprehensive Cancer Center, UNC· Chapel Hill, NCMD Anderson· Houston, TX

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