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Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer (Z1031)
This study is currently recruiting participants.
Verified by University of Medicine and Dentistry New Jersey, August 2008
First Received: June 12, 2008   Last Updated: August 6, 2008   History of Changes
Sponsors and Collaborators: University of Medicine and Dentistry New Jersey
American College of Surgeons
Information provided by: University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier: NCT00698971
  Purpose

Researchers have been studying breast cancer to learn the best way to treat the disease. Chemotherapy (treatment with anti-cancer drugs) is commonly given before surgery to shrink breast tumors. Research has shown that reducing the amount of the hormone estrogen that gets to the cancer in postmenopausal women with hormone-dependent breast cancer can shrink the breast tumor before surgery.

In this research study 3 drugs called hormone therapy (a drug used to lower the level of the hormone estrogen) will be tested. The hormone therapies being tested in this study are exemestane, anastrozole, letrozole.

The purpose of this study is to find out whether it is better to receive exemestane, anastrozole, or letrozole to improve the chance that the breast cancer will get smaller before surgery.


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

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer Surgery
Drug Information available for: Exemestane Letrozole Anastrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:
  • Clinical response (complete or partial response) rate at baseline and week 16 [ Time Frame: 16-18 weeks with periodic follow-up over a ten year period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiological response rate at baseline and week 16 [ Time Frame: 16 weeks with periodic follow-up over ten year period ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: January 2006
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
I: Active Comparator
Patients receive oral exemestane once daily for 16-18 weeks.
Drug: exemestane
Patients receive oral exemestane once daily for 16-18 weeks.
II: Active Comparator
Patients receive oral letrozole once daily for 16-18 weeks.
Drug: letrozole
Patients receive oral letrozole once daily for 16-18 weeks.
III: Active Comparator
Patients receive oral anastrozole once daily for 16-18 weeks.
Drug: anastrozole
Patients receive oral anastrozole once daily for 16-18 weeks.

  Eligibility

Ages Eligible for Study:   65 Years and older
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 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
  • Must have estrogen receptor (ER) positive tumor with an Allred score of 6, 7 or 8

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
  • If patient is a cancer survivor, all of the following criteria must be met:

    • Must have undergone potentially curative therapy for all prior malignancies
    • No evidence of any prior malignancies for at least 5 years with no evidence of recurrence (except for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, or non-melanoma skin cancer with no evidence of recurrence)
    • Deemed by their treating physician to be at low risk for recurrence

PRIOR CONCURRENT THERAPY:

  • Any agent with estrogenic or putatively estrogenic properties, including herbal preparations, must be stopped at least one week prior to registration
  • No prior treatment for breast cancer, including radiation, endocrine therapy, chemotherapy, or investigational agent
  • No concurrent enrollment in another neoadjuvant clinical trial for treatment of the existing breast cancer
  • No hormone replacement therapy of any type, megestrol acetate, or raloxifene within one week prior to registration
  • No other concurrent anti-neoplastic approach such as chemotherapy or radiation therapy
  • Concomitant use of agents and herbal products that alter ER function are specifically not allowed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698971

Contacts
Contact: Robert Wieder, MD, PHD 9739724871 WIEDERRO@UMDNJ.EDU
Contact: Yasmeen S Barber, BA 9739727789 barberys@UMDNJ.EDU

Locations
United States, New Jersey
University of Medicine and Dentistry of New Jersey Recruiting
Newark, New Jersey, United States, 07101-1709
Contact: Yasmeen S Barber, BA     973-972-7789     barberys@umdnj.edu    
Principal Investigator: Robert Wieder, MD, PhD            
Sub-Investigator: Lillian Pliner, MD            
Sub-Investigator: Margarette Bryan, MD            
Sub-Investigator: Kevin Clarke, MD            
Sub-Investigator: Meera Hameed, MD            
Sub-Investigator: Dolly Razdan, MD            
Sub-Investigator: Charles Cathcart, MD            
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
American College of Surgeons
Investigators
Study Chair: Matthew J. Ellis,, MB, PhD, FRCP Washington University in St. Louis, Missouri
  More Information

No publications provided

Responsible Party: American College of Surgeons Oncology Group ( Matthew J. Ellis, MB, PhD, FRCP, Study Chair )
Study ID Numbers: 0120070323
Study First Received: June 12, 2008
Last Updated: August 6, 2008
ClinicalTrials.gov Identifier: NCT00698971     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Estrogens
Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Breast Neoplasms
Letrozole
Exemestane
Aromatase Inhibitors
Breast Diseases

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 May 07, 2009