Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: anastrozole; exemestane; letrozole; Therapeutic Conventional Surgery
Intervention description: Given PO; Given PO; Given PO; Undergo partial or radical mastectomy or lumpectomy with or without lymph node dissection
Intervention MeSH terms: Letrozole; Anastrozole; Exemestane
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 622.0
Sex: Female
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; estrogen receptor-positive breast cancer

Summary:

      RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using
      exemestane, letrozole, or anastrozole, may fight breast cancer by lowering the amount of
      estrogen the body makes. Giving exemestane, letrozole, or anastrozole before surgery may make
      the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not
      yet known whether exemestane, letrozole, or anastrozole is more effective in treating breast
      cancer.

      PURPOSE: This randomized phase III trial is studying exemestane, letrozole, and anastrozole
      to compare how well they work in treating postmenopausal women who are undergoing surgery for
      stage II or stage III breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of breast cancer

               -  T2-T4c, any N, M0 disease

          -  Clinically staged, as documented by the treating physician, as 1 of the following:

               -  T4a-c disease for which modified radical mastectomy with negative margins is the
                  goal

               -  T2 or T3 disease for which conversion from needing mastectomy to breast
                  conservation is the goal

               -  T2 disease for which lumpectomy at first attempt is the goal

          -  Primary tumor must be palpable and measure > 2 cm by tape, ruler, or caliper
             measurements in at least one dimension

          -  Must agree to undergo mastectomy or lumpectomy after neoadjuvant aromatase inhibitor
             therapy

          -  No inflammatory breast cancer, defined as clinically significant erythema of the
             breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor
             or peau d'orange without erythema)

          -  No distant metastasis (M1)

               -  Isolated ipsilateral supraclavicular node involvement allowed

          -  No diagnosis that was established by incisional biopsy

          -  Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8

               -  Patients with > 66.66% (two-thirds) of cells staining positive and have a minimum
                  Allred score of 6 are eligible

        PATIENT CHARACTERISTICS:

          -  ECOG/Zubrod performance status of ≤ 2

          -  Female

          -  Patient must be postmenopausal, verified by 1 of the following:

               -  Bilateral surgical oophorectomy

               -  No spontaneous menses ≥ 1 year

               -  No menses for < 1 year with FSH and estradiol levels in postmenopausal range

          -  No other malignancies within the past 5 years, except for successfully treated
             cervical carcinoma in situ; lobular carcinoma in situ of the breast; contralateral
             ductal carcinoma in situ that was treated with mastectomy or lumpectomy with
             radiotherapy (without tamoxifen); or non-melanoma skin cancer with no evidence of
             recurrence

               -  Must have undergone potentially curative therapy for all prior malignancies AND
                  deemed to be at low risk for recurrence, according to the treating physician

        PRIOR CONCURRENT THERAPY:

          -  No prior treatment for invasive breast cancer, including radiotherapy, endocrine
             therapy, chemotherapy, or investigational agents

          -  No prior sentinel lymph node biopsy (cohort B only)

          -  At least 1 week since prior agents with estrogenic or putatively estrogenic
             properties, including herbal preparations

          -  At least 1 week since prior hormone replacement therapy of any type, megestrol
             acetate, or raloxifene

          -  No concurrent enrollment in another neoadjuvant clinical trial for treatment of the
             existing breast cancer

          -  No other concurrent anti-neoplastic therapy, including chemotherapy or radiotherapy

          -  No concurrent agents or herbal products that alter ER function