Erlotinib in Treating Women Undergoing Surgery For Stage I, Stage II, or Stage III Breast Cancer

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This clinical trial is studying how well erlotinib works in treating women undergoing surgery for stage I, stage II, or stage III breast cancer.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

Inclusion

• Cytologically or histologically confirmed adenocarcinoma of the breast

• Stage I-III disease

• BI-RADS 4 or 5 abnormalities on breast imaging and undergoing core needle biopsy for diagnosis

• Participants must have a lesion of at least 1-cm on breast imaging studies (mammogram, ultrasound, or MRI)

• Participants must have breast cancer amenable to surgery with curative intent and must have agreed to undergo such surgery

• The surgical procedure must be scheduled in the near future to accommodate a treatment period of no less and no more than 15 days

• Clinically positive for the overexpression of EGFR and interleukin-1α

• Clinically negative for expression of the estrogen receptor (ER-negative) and progesterone receptor (PgR-negative)

• May be positive or negative for HER2

Exclusion

• Locally advanced or metastatic disease not amenable to surgery

• Known brain metastases

PATIENT CHARACTERISTICS:

Inclusion

• Female

• Menopausal status not specified

• ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%

• ANC ≥ 1000/mm³

• Platelet count ≥ 75,000/mm³

• AST and ALT ≤ 2.5 times upper limits of normal (ULN)

• Alkaline phosphatase ≤ 2.5 times ULN

• Bilirubin ≤ 2 times ULN

• Hemoglobin > 9 g/dL

• Creatinine within normal institutional limits OR creatinine clearance >60 mL/min

• Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women and women within 6 months of menopause

• Women of child-bearing potential and their partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

Exclusion

• Pregnant or nursing

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib hydrochloride

• Uncontrolled intercurrent illness including, but not limited to, any of the following:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Cardiac arrhythmia

• Psychiatric illness/social situations that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

Exclusion

• Received any other therapy (i.e., surgery, radiation, hormone treatment, biologic therapy, and/or chemotherapy) for the treatment of breast cancer

• Concurrent use of anti-neoplastic or anti-tumor agents not part of the study therapy, including chemotherapy, radiation therapy, immunotherapy, and hormonal anticancer therapy

• Receiving any other investigational agents