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Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer Previously Treated With Tamoxifen

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2010 by National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 5, 2010
Last updated: August 23, 2013
Last verified: February 2010

February 5, 2010
August 23, 2013
August 2005
August 2015   (final data collection date for primary outcome measure)
Disease-free survival [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01064635 on Archive Site
  • Overall survival [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, Stage II, or Stage III Breast Cancer Previously Treated With Tamoxifen
Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.

RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is most effective in treating breast cancer in postmenopausal women who have received tamoxifen.

PURPOSE: This randomized phase III trial is comparing different regimens of letrozole to see how well they work in treating postmenopausal women with stage I, stage II, or stage III breast cancer previously treated with tamoxifen.



  • 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.


  • 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.
Phase 3
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: letrozole
  • Procedure: adjuvant therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
August 2015   (final data collection date for primary outcome measure)


  • 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


  • 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


  • See Disease Characteristics
  • Prior aromatase inhibitors allowed
  • Concurrent bisphosphonates allowed
18 Years and older
CDR0000665188, GIM-4-LEAD, EUDRACT-2005-001212-44, EU-21003
Not Provided
Not Provided
Gruppo Italiano Mammella (GIM)
Not Provided
Principal Investigator: Lucia Del Mastro, MD National Institute for Cancer Research, Italy
National Cancer Institute (NCI)
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP