Anastrozole or Tamoxifen in Treating Postmenopausal Women With Ductal Carcinoma in Situ Who Are Undergoing Lumpectomy and Radiation Therapy
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00053898
- Lead Sponsor
- NSABP Foundation Inc
- Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Tamoxifen may fight breast cancer by blocking the use of estrogen. Anastrozole may fight breast cancer by decreasing estrogen production. It is not yet known whether anastrozole is more effective than tamoxifen in preventing the recurrence of breast cancer.
PURPOSE: This randomized phase III trial is studying anastrozole to see how well it works compared to tamoxifen in preventing the recurrence of breast cancer in postmenopausal women with ductal carcinoma in situ who are undergoing lumpectomy and radiation therapy.
- Detailed Description
OBJECTIVES:
* Compare the value of anastrozole vs tamoxifen, in terms of preventing recurrence (i.e., local, regional, and distant recurrences and contralateral breast cancer), after lumpectomy and radiotherapy in postmenopausal women with ductal carcinoma in situ (DCIS).
* Compare subsequent disease occurrence, in terms of invasive breast cancer (local, regional, distant, or contralateral), ipsilateral and contralateral breast cancer (invasive and DCIS), and non-breast second primary malignancies, in patients treated with these drugs.
* Compare quality of life and symptoms of patients treated with these drugs.\*
* Compare quality-adjusted survival time of patients treated with these drugs.\*
* Compare the occurrence of osteoporotic fractures in patients treated with these drugs.
* Compare disease-free and overall survival of patients treated with these drugs. NOTE: \*The quality of life study closed to accrual as of 12/28/04.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (under 60 vs 60 and over). Patients are randomized to 1 of 2 treatment arms (arm I and arm II closed to accrual as of 6/15/06).
* Arm I (closed to accrual as of 6/15/06): Patients receive oral tamoxifen and oral placebo once daily for 5 years.
* Arm II (closed to accrual as of 6/15/06): Patients receive oral anastrozole and oral placebo once daily for 5 years.
Beginning within 8 weeks of randomization, all patients also undergo whole breast radiotherapy, unless the patient is enrolled in protocol NSABP-B-39 and randomized to the partial breast irradiation group.
Patients are followed every 6 months for 5 years, and then annually thereafter.
For patients enrolled in the quality of life study, quality of life is assessed at baseline and then every 6 months for 6 years.\*
NOTE: \*The quality of life study closed to accrual as of 12/28/04.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 5 years (arm I and arm II closed to accrual as of 6/15/06).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 3104
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 tamoxifen citrate tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years Group 1 Radiation Therapy tamoxifen 20 mg/day and an anastrozole look-alike placebo for 5 years Group 2 anastrozole anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years Group 2 Radiation Therapy anastrozole, 1 mg/day and an tamoxifen look-alike placebo for 5 years
- Primary Outcome Measures
Name Time Method Percentage of Patients Free From Breast Cancer 10 years Percentage of patients free from breast cancer event at 10 years where events include local, regional, or distant recurrence or contralateral breast cancer, invasive or DCIS.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Free From Non-breast Secondary Cancer 10 years Percentage of patients free from any non-breast second primary cancer other than squamous or basal cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, or carcinoma in situ of the cervix, occurring as a first cancer event.
Percentage of Patients Free From Invasive Breast Cancer 10 years Percentage of patients free from an invasive breast cancer event where events include invasive local, regional, or distant recurrence, or contralateral breast cancer, occurring as a first cancer event. Note that this endpoint includes only invasive breast cancers and the primary endpoint includes both invasive and DCIS breast cancers.
Percentage of Patients Free From Ipsilateral Recurrence 10 years Percentage of patients free from a breast cancer recurrence in the ipsilateral breast (invasive and DCIS), occurring as a first cancer event.
Percentage of Patients Alive (Overall Survival) 10 years Percentage of patients alive.
Percentage of Patients Free From Contralateral Breast Cancer 10 years Percentage of patients free from a breast cancer recurrence in the contralateral breast (invasive and DCIS), occurring as a first cancer event.
Percentage of Patients Free From Osteoporotic Fractures 10 years Percentage of patients free from fractures of the hip, spine, and wrist.
Percentage of Patients Alive and Disease-free 10 years Percentage of patients free from a disease-free survival event where events include any recurrence, second primary cancer, and death from any cause. Lobular carcinoma in situ (LCIS), basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the colon, melanoma in situ, and cervical carcinoma in situ will not be included as recurrences or second primary cancer.
Quality of Life-Short Form 12 (SF-12) Physical Health Component Score 5 years The primary outcome of the QOL substudy was the Medical Outcomes Study-Short Form 12 (SF-12) physical health component scale score. The SF-12 physical score was calculated to have a range of 0-100 and was normalized to have a mean of 50 and a standard deviation of 10 in the general population. Higher scores indicate better health.
Quality-adjusted Survival Time 10 years The mean quality-adjusted survival time (in months) in each treatment group, estimated by the Quality-Adjusted Time without Symptoms and Toxicity (Q-TWIST) method.
Trial Locations
- Locations (734)
Northeast Alabama Regional Medical Center
🇺🇸Anniston, Alabama, United States
Comprehensive Cancer Center at University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States
East Alabama Medical Center
🇺🇸Opelika, Alabama, United States
Cancer Center at Providence Alaska Medical Center
🇺🇸Anchorage, Alaska, United States
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States
Banner Thunderbird Medical Center
🇺🇸Glendale, Arizona, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
Scroll for more (724 remaining)Northeast Alabama Regional Medical Center🇺🇸Anniston, Alabama, United States