PhII Neo-Adjuvant Letrozole & Lapatinib in Pts w/HER2+ & Hormone Receptor+ Operable Breast CA SPORE

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00499681
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib ditosylate — DRUG
    Given once daily, 1500mg, for 2 weeks; Given once daily, 1500mg, for 14 weeks in Arm II
  • letrozole — DRUG
    Given once daily, 2.5mg, for 2 weeks; Given once daily, 2.5mg, for 14 weeks
  • placebo — OTHER
    Given once daily for 2 weeks

Study Details

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving letrozole together with lapatinib works in treating postmenopausal women with stage I, stage II, or stage III breast cancer that can be removed by surgery.

Key Dates

Start date
Jul 31, 2007
Status verified
Aug 2012
Primary completion
Oct 31, 2009
Completion
Dec 31, 2010

Study Design

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

Arms

  • Experimental: Arm I
    Patients receive Lapatinib and Letrozole once daily for two weeks, following tumor measurement patients receive Lapatinib and Letrozole once daily for 14 weeks.
  • Experimental: Arm II
    Patients receive Letrozole and placebo once daily for 2 weeks, following tumor measurement patients receive Letrozole and Lapatinib once daily for 14 weeks.

Primary Outcome Measure

Number of Participants With a Pathological Complete Response [ Time Frame: at 14 weeks ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBostonMassachusetts02115-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37064-
Vanderbilt-Ingram Cancer Center at FranklinNashvilleTennessee37064-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute· Boston, MAVanderbilt-Ingram Cancer Center· Nashville, TNVanderbilt-Ingram Cancer Center - Cool Springs· Nashville, TNVanderbilt-Ingram Cancer Center at Franklin· Nashville, TN

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