Ph II Letrozole + OSI-774 (Tarceva) in Post-menopausal, w/ ER and/or PR-positive Met Breast Cancer.

Part of paid clinical trials in Macon, Georgia.

Sponsor
Vanderbilt-Ingram Cancer Center
Study ID
NCT00611715
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    OSI-774 150 mg/day
  • letrozole — DRUG
    Letrozole 2.5 mg/day
  • fluorescence in situ hybridization — GENETIC
    To determine HER2 gene amplification or excess copies of the HER2 gene
  • immunohistochemistry staining method — OTHER
    to measure the epidermal growth factor receptors (EGFR)
  • laboratory biomarker analysis — OTHER
    To determine if specific biomarkers exhibit a longer time to tumor progression after treatment with the study drugs

Study Details

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells. PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.

Key Dates

First listed
Feb 11, 2008
Start date
Nov 30, 2003
Status verified
Aug 2012
Primary completion
Dec 31, 2008
Completion
Dec 31, 2008

Study Design

Enrollment
48 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: First line/hormone-therapy naive
  • Experimental: Second-line/prev hormone-therapy tx

Primary Outcome Measure

Number of Patients With Pathological Complete Response. [ Time Frame: at 24 weeks ]

Locations (9)

FacilityCityStateZIPSite coordinators
Central Georgia Hematology/Oncology Associates, P.C.MaconGeorgia31201-
Jennie Stuart Medical CenterHopkinsvilleKentucky42240-
Purchase Cancer GroupPaducahKentucky42002-
Memorial Health Care SystemChattanoogaTennessee37404-
The Jones Clinic - GermantownGermantownTennessee38138-
Jackson-Madison County HospitalJacksonTennessee38301-
Tennessee Cancer SpecialistsKnoxvilleTennessee37909-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-6838-
Vanderbilt-Ingram Cancer Center - Cool SpringsNashvilleTennessee37067-

Find similar trials in Macon, GA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Central Georgia Hematology/Oncology Associates, P.C.· Macon, GAJennie Stuart Medical Center· Hopkinsville, KYPurchase Cancer Group· Paducah, KYMemorial Health Care System· Chattanooga, TNThe Jones Clinic - Germantown· Germantown, TNJackson-Madison County Hospital· Jackson, TN

Related Studies