Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.
18 Years
N/A
Female
Breast Cancer
Trial Information
Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.
OBJECTIVES:
Primary
- To compare the disease-free survival of previously treated, post-menopausal women with
early-stage breast cancer treated with standard- (2-3 years of tamoxifen followed by
2-3 years of letrozole) versus long-treatment (2-3 years of tamoxifen followed by 5
years of letrozole) adjuvant letrozole.
Secondary
- To compare the overall survival of these patients.
- To compare the safety of these patients.
OUTLINE: Patients are randomized to 1 or 2 treatment arms.
- Arm I (standard treatment): Patients previously treated with tamoxifen for 2 years
receive letrozole for an additional 3 years; patients previously treated with tamoxifen
for 3 years receive letrozole for an additional 2 years; and patients previously
treated with tamoxifen for 2-3 years receive letrozole , so the total duration of the
endocrine treatment (i.e., tamoxifen followed by letrozole) is 5 years.
- Arm II (long treatment): Patients receive letrozole for an additional 5 years
regardless of the duration of the previous tamoxifen treatment.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer at first diagnosis
- Stage I, II, or III disease
- Documented (microscopic) infiltration of the skin (pT4) allowed
- Nx, pNo, pN1, pN2, PN3 axillary nodal status allowed
- Received adjuvant tamoxifen for at least 2 years but no more than 3 years and 3
months
- Patients treated with adjuvant chemotherapy must have begun receiving tamoxifen
within 3 months after the completion of chemotherapy
- Definitive surgical treatment must be either mastectomy or breast-conserving surgery
with axillary lymph node dissection OR sentinel node biopsy for operable breast
cancer
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG or WHO performance status 0-1
- Post-menopausal status meeting 1 of the following criteria:
- Age > 55 years with cessation of menses
- Age < 55 years but no spontaneous menses for at least 1 year
- Age < 55 years and spontaneous menses within the past 1 year, but currently
amenorrheic (e.g., spontaneous or secondary to hysterectomy), AND with
postmenopausal gonadotropin levels (luteinizing hormone and follicle-stimulating
hormone levels > 40 IU/L) or postmenopausal estradiol levels (< 5 ng/dL) or
according to the definition of "postmenopausal range" for the laboratory
involved
- Underwent a bilateral oophorectomy
- Must be accessible for treatment and follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior aromatase inhibitors allowed
- Concurrent bisphosphonates allowed
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival
Safety Issue:
No
Principal Investigator
Lucia Del Mastro, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Institute for Cancer Research, Italy
Authority:
Unspecified
Study ID:
CDR0000665188
NCT ID:
NCT01064635
Start Date:
August 2005
Completion Date:
Related Keywords:
- Breast Cancer
- stage IA breast cancer
- stage IB breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
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