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

Phase 2

Terminated

Interventions: Drug: erlotinib hydrochloride
Drug: letrozole
Genetic: fluorescence in situ hybridization
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis

Brief Summary: 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.

Detailed Description: OBJECTIVES:

Primary

* To determine the rate of clinical benefit (complete response \[CR\], partial response \[PR\], and stable disease \[SD\] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride.

Secondary

* To determine the time to progression (TTP) in patients treated with this regimen.

* To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients.

* To evaluate the safety of this regimen in these patients.

* To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules.

OUTLINE: This is a multicenter study. Patients are stratified according to prior hormone therapy (hormone-therapy naive/first-line therapy vs prior hormonal therapy with either tamoxifen or an aromatase inhibitor in the adjuvant or metastatic setting/second-line therapy)

Patients receive oral letrozole and oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then yearly thereafter.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
First line/hormone-therapy naive	erlotinib hydrochloride	-
First line/hormone-therapy naive	fluorescence in situ hybridization	-
First line/hormone-therapy naive	immunohistochemistry staining method	-
First line/hormone-therapy naive	laboratory biomarker analysis	-
Second-line/prev hormone-therapy tx	erlotinib hydrochloride	-
Second-line/prev hormone-therapy tx	fluorescence in situ hybridization	-
Second-line/prev hormone-therapy tx	immunohistochemistry staining method	-
Second-line/prev hormone-therapy tx	laboratory biomarker analysis	-
First line/hormone-therapy naive	letrozole	-
Second-line/prev hormone-therapy tx	letrozole	-

Primary Outcome Measures

Name	Time	Method
Number of Patients With Pathological Complete Response.	at 24 weeks	Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions

Secondary Outcome Measures

Name	Time	Method
Median Time to Progression of Target Lesions	Every 12 weeks from on-study to disease progression	Time frame from study entry till discontinuation of treatment due to disease progression. Progression of target lesions is measured by RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) \> 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)	at 24 weeks	Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions and partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions.
Number of Patients With Worst-grade Toxicities Per Grade	at 24 weeks	Number of patients with worst-grade toxicities following NCI Common Toxicity Criteria: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death

Locations (9): Jackson-Madison County Hospital
🇺🇸
Jackson, Tennessee, United States
The Jones Clinic - Germantown
🇺🇸
Germantown, Tennessee, United States
Tennessee Cancer Specialists
🇺🇸
Knoxville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸
Nashville, Tennessee, United States
Central Georgia Hematology/Oncology Associates, P.C.
🇺🇸
Macon, Georgia, United States
Jennie Stuart Medical Center
🇺🇸
Hopkinsville, Kentucky, United States
Purchase Cancer Group
🇺🇸
Paducah, Kentucky, United States
Memorial Health Care System
🇺🇸
Chattanooga, Tennessee, United States