Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer (Z1031)
Recruitment status was Recruiting
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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 |
|---|---|
|
Active Comparator: I
Patients receive oral exemestane once daily for 16-18 weeks.
|
Drug: exemestane
Patients receive oral exemestane once daily for 16-18 weeks.
|
|
Active Comparator: II
Patients receive oral letrozole once daily for 16-18 weeks.
|
Drug: letrozole
Patients receive oral letrozole once daily for 16-18 weeks.
|
|
Active Comparator: III
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 |
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| Contact: Robert Wieder, MD, PHD | 9739724871 | WIEDERRO@UMDNJ.EDU |
| Contact: Yasmeen S Barber, BA | 9739727789 | barberys@UMDNJ.EDU |
| 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 | |
| Study Chair: | Matthew J. Ellis,, MB, PhD, FRCP | Washington University in St. Louis, Missouri |
More Information
No publications provided
| Responsible Party: | Matthew J. Ellis, MB, PhD, FRCP, Study Chair, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00698971 History of Changes |
| Other Study ID Numbers: | 0120070323 |
| Study First Received: | June 12, 2008 |
| Last Updated: | August 6, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Estrogens Exemestane Letrozole Anastrozole Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on June 13, 2013