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NCT00016432 · CITED IN SOURCE DOCUMENTS

Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2011-04-19

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed invasive adenocarcinoma of the breast at time of original diagnosis * Tumor confined to the breast and ipsilateral axilla on clinical exam (T1-3, N0-1, M0) (stage I-IIIA) * No ipsilateral lymph nodes clinically fixed to one another or to other structures (N2 disease) at time of original diagnosis * Prior surgical resection, including 1 of the following: * Total mastectomy and axillary dissection (modified radical mastectomy) OR * Lumpectomy and axillary dissection * Prior post-lumpectomy breast radiotherapy required * Prior sentinel node biopsy allowed with the exception of the following: * If any sentinel node is histologically positive by hematoxylin and eosin (H \& E) OR histologically suspicious on H \& E and confirmed positive by immunohistochemistry then the patient must have a complete axillary dissection * Previously resected margins must be clear of invasive tumor and ductal carcinoma in situ * Currently disease free * Previously treated with tamoxifen for 57-66 months * Completed tamoxifen within the past 180 days * No bilateral malignancy or mass in the opposite breast suspicious for malignancy unless biopsy proven negative * No local, regional, or distant recurrence of disease or second primary breast malignancy (including contralateral breast cancer) * No advanced disease at time of original diagnosis (e.g., ulceration, erythema, infiltration of the skin or underlying chest wall \[complete fixation\], peau d'orange, or skin edema of any magnitude) * Tethering or dimpling of the skin or nipple inversion allowed * Current skeletal pain allowed if a bone scan and/or radiologic exam is negative for metastatic disease * Hormone receptor status: * Primary tumor estrogen receptor (ER) positive AND/OR * Progesterone receptor positive * Borderline ER positive tumors allowed if previously treated with tamoxifen PATIENT CHARACTERISTICS: Age: * Postmenopausal Sex: * Female Menopausal status: * Postmenopausal, defined as 1 of the following: * Prior bilateral oophorectomy * Absence of spontaneous menstrual cycle for more than 1 year * Follicle-stimulating hormone within the postmenopausal range if under 55 and had a prior hysterectomy without a bilateral oophorectomy Performance status: * Not specified Life expectancy: * At least 10 years Hematopoietic: * Absolute granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin normal Hepatic: * Bilirubin less than 2 times upper limit of normal (ULN) * SGOT or SGPT no greater than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN * No systemic hepatic disease that would preclude study participation Renal: * Creatinine no greater than 1.5 times ULN * No systemic renal disease that would preclude study participation Cardiovascular: * No systemic cardiovascular disease that would preclude study participation Other: * No other malignancy within the past 5 years except effectively treated squamous cell or basal cell skin cancer, surgically treated carcinoma in situ of the cervix, or surgically treated lobular carcinoma in situ of the ipsilateral or contralateral breast * No nonmalignant systemic disease that would preclude study participation * No psychiatric or addictive disorder that would preclude informed consent * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant chemotherapy allowed if administered concurrently with or prior to tamoxifen Endocrine therapy: * See Disease Characteristics * No concurrent estrogen, progesterone, clomiphene, testosterone, gonadotropin-releasing hormone, oral contraceptives, selective estrogen-receptor modulators, or dehydroepiandrosterone (DHEA) * Estring or estrogen vaginal cream at 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week allowed * No other concurrent systemic hormonal therapy (e.g., tamoxifen or raloxifene) Radiotherapy: * See Disease Characteristics * Prior post-mastectomy loco-regional radiotherapy or post-lumpectomy regional radiotherapy allowed Surgery: * See Disease Characteristics Other: * Prior participation in other adjuvant NSABP study allowed if study was reported in peer-review publication or tamoxifen was not a study drug * Concurrent bisphosphonates or calcitonin for prevention or treatment of osteoporosis allowed * Concurrent statins (simvastatin, pravastatin, fluvastatin, atorvastatin, or lovastatin) or other drugs to control lipid levels allowed
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Exemestane
    intervention Names
    1. Drug: exemestane
    label
    Group 1
    type
    EXPERIMENTAL
  2. description
    Placebo
    intervention Names
    1. Drug: Placebo
    label
    Group 2
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Group 1
    description
    25 mg for 5 years
    name
    exemestane
    type
    DRUG
  2. arm Group Labels
    1. Group 2
    description
    Placebo
    name
    Placebo
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
SINGLE_GROUP
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
1598
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Disease-free survival
    time Frame
    Every 12 months until breast cancer recurrence, second primary cancer or death from any cause.
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    Death from any cause
  2. measure
    Time to treatment failure
    time Frame
    time from randomization to recurrence or contralateral second primary cancer
  3. measure
    Bone measure as measured by total alkaline phosphatase, fracture history, and height measurement
    time Frame
    measurements taken at regular intervals from randomization through 6 years following randomiztion
Full study description
brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.
detailed Description
OBJECTIVES: * Determine whether the administration of 5 years of exemestane after 5 years of tamoxifen therapy is more effective than 5 years of prior tamoxifen therapy alone in prolonging disease-free survival, overall survival, and time to treatment failure in postmenopausal women with resected stage I, II, or IIIA breast cancer. * Determine the effect of tamoxifen withdrawal on bone, in terms of height, fractures, and total alkaline phosphatase in these patients and on bone mineral density and bone biochemical markers in a subset of patients. * Determine the effect of exemestane on bone loss after tamoxifen withdrawal in these patients. * Evaluate the quality of life of a subset of these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral exemestane daily for 5 years. * Arm II (closed as of 10/15/03): Patients receive an oral placebo daily for 5 years. Quality of life is assessed at baseline and then every 6 months for 5.5 years. Patients are followed every 6 months for 6 years and then annually thereafter. PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study within 3 years and 4 months.
Source references
references
  1. citation
    Mamounas EP, Jeong JH, Wickerham DL, Smith RE, Ganz PA, Land SR, Eisen A, Fehrenbacher L, Farrar WB, Atkins JN, Pajon ER, Vogel VG, Kroener JF, Hutchins LF, Robidoux A, Hoehn JL, Ingle JN, Geyer CE Jr, Costantino JP, Wolmark N. Benefit from exemestane as extended adjuvant therapy after 5 years of adjuvant tamoxifen: intention-to-treat analysis of the National Surgical Adjuvant Breast And Bowel Project B-33 trial. J Clin Oncol. 2008 Apr 20;26(12):1965-71. doi: 10.1200/JCO.2007.14.0228. Epub 2008 Mar 10.
    pmid
    18332472
    type
    RESULT
  2. citation
    Mamounas E, Jeong J-H, Wickerham L, et al.: Benefit from exemestane (EXE) as extended adjuvant therapy after 5 years of tamoxifen (TAM): intent-to-treat analysis of NSABP B-33. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-49, S22, 2006.
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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        8&#8211;0.98; <em>P</em> = .04), although the <em>P</em> value was not corrected for multiple comparisons.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00016432">NSABP B-33</a> trial (NCT00016432) that was designed to compare 5 years of exemestane with placebo after 5 years of tamoxifen was stopped prematurely when the
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        though the <em>P</em> value was not corrected for multiple comparisons.</li></ul></div></li><li>The <a href="/clinicaltrials/NCT00016432">NSABP B-33</a> trial (NCT00016432) that was designed to compare 5 years of exemestane with placebo after 5 years of tamoxifen was stopped prematurely when the results of <a href="/clinicaltrial
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      source title
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      source update dates
      1. context
        Updated: April 25, 2025
        datetime
        2025-04-25T12:00:00Z
        display
        April 25, 2025

    Preserved source evidence · Not medical advice