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Status:

COMPLETED

Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer

Lead Sponsor:

Alliance for Clinical Trials in Oncology

Collaborating Sponsors:

National Cancer Institute (NCI)

Cancer and Leukemia Group B

Conditions:

Breast Cancer

Eligibility:

FEMALE

Phase:

PHASE3

Brief 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....

Detailed Description

OBJECTIVES: Primary * Determine whether anastrozole, exemestane, or letrozole administered for 16 to 18 weeks as neoadjuvant endocrine treatment for postmenopausal patients with stage II or stage II...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    November 27 2019

    Estimated Enrollment :

    622 Patients enrolled

    Trial Details

    Trial ID

    NCT00265759

    Start Date

    January 1 2006

    End Date

    November 27 2019

    Last Update

    April 23 2025

    Active Locations (3)

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    Page 1 of 1 (3 locations)

    1

    Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

    St Louis, Missouri, United States, 63110

    2

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009

    3

    Doctor's Hospital of Laredo

    Laredo, Texas, United States, 78041