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Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2009
First Received: December 14, 2005   Last Updated: November 19, 2009   History of Changes
Sponsor: American College of Surgeons
Collaborators: National Cancer Institute (NCI)
Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00265759
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: anastrozole
Drug: exemestane
Drug: letrozole
Phase II
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized
Official Title: A Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical response (complete or partial response) rate (cohort A) [ Designated as safety issue: No ]
  • Pathological complete response rate to neoadjuvant chemotherapy (cohort B) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiological response rate [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Progression-free survival and overall survival [ Designated as safety issue: No ]
  • Rate of improvement in surgical outcome [ Designated as safety issue: No ]
  • Rate of downstaging to stage I [ Designated as safety issue: No ]
  • Rate of lymph node involvement [ Designated as safety issue: No ]
  • Pathological complete response rate (cohort A) [ Designated as safety issue: No ]
  • Clinical response rate (cohort B) [ Designated as safety issue: No ]

Estimated Enrollment: 567
Study Start Date: January 2006
Estimated Primary Completion Date: August 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Experimental
Patients receive oral exemestane once daily for up to 16-18 weeks.
Drug: exemestane
Given orally
Arm II: Experimental
Patients receive oral letrozole once daily for up to 16-18 weeks.
Drug: letrozole
Given orally
Arm III: Experimental
Patients receive oral anastrozole once daily for up to 16-18 weeks.
Drug: anastrozole
Given orally

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of breast cancer

    • T2-T4c, any N, M0 disease
  • Clinically staged, as documented by the operating surgeon, 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00265759

Locations
United States, Indiana
Community Hospital Recruiting
Munster, Indiana, United States, 46321
Contact: Erwin L. Robin, MD     219-836-2860        
United States, Iowa
McFarland Clinic, PC Recruiting
Ames, Iowa, United States, 50010
Contact: Clinical Trials Office - McFarland Clinic, PC     515-239-2621        
United States, Maryland
Cancer Institute at St. Joseph Medical Center Recruiting
Towson, Maryland, United States, 21204
Contact: Michael J. Schultz     410-337-1000        
United States, Minnesota
Mayo Clinic Cancer Center Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Office - All Mayo Clinic Locations     507-538-7623        
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Matthew J. Ellis, MD, PhD, FRCP     314-747-7502        
United States, Nebraska
Methodist Estabrook Cancer Center Recruiting
Omaha, Nebraska, United States, 68114
Contact: James A. Reilly, MD     402-354-8163        
United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Clinical Trials Office - Cancer Institute of New Jersey     732-235-8675        
United States, New Mexico
Hematology Oncology Associates, PC Recruiting
Albuquerque, New Mexico, United States, 87106
Contact: Anne M. Wallace, MD     858-822-6193        
New Mexico Cancer Care Associates Recruiting
Santa Fe, New Mexico, United States, 87505
Contact: Clinical Trials Office - New Mexico Cancer Care Associates     505-955-7910        
New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Richard O. Giudice     505-842-8171        
Presbyterian Cancer Treatment Center at Presbyterian Kaseman Hospital Recruiting
Albuquerque, New Mexico, United States, 87110
Contact: Anne M. Wallace, MD     858-822-6193        
University of New Mexico Cancer Center Recruiting
Albuquerque, New Mexico, United States, 87131-5636
Contact: Clinical Trials Office - University of New Mexico Cancer Cente     505-272-6972        
United States, North Carolina
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive     336-713-6771        
United States, Ohio
McDowell Cancer Center at Akron General Medical Center Recruiting
Akron, Ohio, United States, 44307
Contact: Daniel P. Guyton, MD     330-344-6234        
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Recruiting
Allentown, Pennsylvania, United States, 18105
Contact: Paul J. Mosca     610-402-0500        
York Cancer Center at Apple Hill Medical Center Recruiting
York, Pennsylvania, United States, 17405
Contact: Thomas L. Bauer, MD     302-623-4530        
United States, Texas
Dallas Surgical Group Recruiting
Dallas, Texas, United States, 75235
Contact: Peter D. Beitsch, MD, FACS     972-566-8039        
Doctor's Hospital of Laredo Recruiting
Laredo, Texas, United States, 78041
Contact: Gary W. Unzeitig, MD     956-726-3691        
United States, Wisconsin
Franciscan Skemp Healthcare - La Crosse Campus Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Mary Kathleen Christian     608-785-0940        
Sponsors and Collaborators
American College of Surgeons
Cancer and Leukemia Group B
Investigators
Study Chair: Matthew J. Ellis, MD, PhD, FRCP Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
Investigator: John A. Olson, MD, PhD Duke University
Principal Investigator: Kevin S. Hughes, MD, FACS Massachusetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: American College of Surgeons Oncology Group ( David M. Ota )
Study ID Numbers: CDR0000456382, ACOSOG-Z1031, CALGB-ACOSOG-Z1031
Study First Received: December 14, 2005
Last Updated: November 19, 2009
ClinicalTrials.gov Identifier: NCT00265759     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
estrogen receptor-positive breast cancer

Additional relevant MeSH terms:
Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Letrozole
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Exemestane
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on November 20, 2009