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

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer Read More

DISEASE CHARACTERISTICS:

Inclusion Criteria:

• Clinical stage I, II, or III operable invasive mammary carcinoma, confirmed by histological analysis

  • Measurable residual tumor at the primary site

    • Measurable disease is defined as any mass that can be reproducibly measured by physical examination, mammogram, and/or ultrasound and can be accurately measured in at least one dimension (longest diameter to be recorded) as 10 mm (1 cm)

• Available core biopsies from the time of diagnosis

  • May include sections of paraffin-embedded material
• Scheduled to undergo surgical treatment with either segmental resection or total mastectomy
• Prior history of contralateral breast cancer allowed if patient has no evidence of recurrence of their initial primary breast cancer within the last 5 years
• HER2-positive by Herceptest (3+) or FISH
• ER-positive and/or PR-positive by IHC

Exclusion Criteria:

• Locally recurrent breast cancer
• Evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)

PATIENT CHARACTERISTICS:

Inclusion Criteria:

• Female

• Postmenopausal, as defined by any of the following:

  • At least 55 years of age
  • Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 40 IU/L and estradiol levels ≤ 20 IU/L
  • Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
• ECOG performance status 0-1
• ANC ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 1.5 times ULN
• Able to swallow and retain oral medication
• Cardiac ejection fraction normal by echocardiogram (or MUGA scan if an echocardiogram cannot be performed or is inconclusive)

Exclusion Criteria:

• Premenopausal breast cancer, pregnant, or lactating
• Serious medical illness, that in the judgment of the treating physician, places the patient at high risk of operative mortality
• Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
• Ulcerative colitis

• History of other malignancy

  • Patients who have been disease-free for 5 years, or patients with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinomas are eligible
• Active or uncontrolled infection
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent
• Known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure

PRIOR CONCURRENT THERAPY:

Exclusion Criteria:

• Prior chemotherapy for primary breast cancer
• Tamoxifen or raloxifene as a preventive agent within the past 21 days
• Hormone replacement therapy (e.g., conjugated estrogens tablets [Premarin]) within the past month
• Prior therapy with anthracyclines
• Investigational drug within the past 30 days or 5 half-lives, whichever is longer
• Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, or any other biologic therapy) other than letrozole
• Concurrent treatment with an investigational agent