Exemestane, Letrozole, or Anastrozole in Treating Postmenopausal Women Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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 (cohort A) [ Designated as safety issue: No ]
- Pathological complete response rate to neoadjuvant chemotherapy (cohort B) [ Designated as safety issue: No ]
- 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: | 610 |
| Study Start Date: | January 2006 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral exemestane once daily for up to 16-18 weeks.
|
Drug: exemestane
Given orally
|
|
Experimental: Arm II
Patients receive oral letrozole once daily for up to 16-18 weeks.
|
Drug: letrozole
Given orally
|
|
Experimental: Arm III
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 |
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
Contacts and Locations| United States, Missouri | |
| Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
| Saint Louis, Missouri, United States, 63110 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Doctor's Hospital of Laredo | |
| Laredo, Texas, United States, 78041 | |
| Study Chair: | Matthew J. Ellis, MD, PhD, FRCP | Washington University Siteman Cancer Center |
| Investigator: | John A. Olson, MD, PhD | Duke Cancer Institute |
| Principal Investigator: | Kevin S. Hughes, MD, FACS | Massachusetts General Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | David M. Ota, American College of Surgeons Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00265759 History of Changes |
| Other Study ID Numbers: | CDR0000456382, ACOSOG-Z1031, CALGB-ACOSOG-Z1031 |
| Study First Received: | December 14, 2005 |
| Last Updated: | July 6, 2012 |
| Health Authority: | United States: Federal Government |
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:
|
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 May 16, 2013