Letrozole in Treating Breast Cancer in Postmenopausal Women With Stage I, II, or III Breast Cancer Previously Treated With Tamoxifen (GIM4) (GIM4)
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|ClinicalTrials.gov Identifier: NCT01064635|
Recruitment Status : Active, not recruiting
First Posted : February 8, 2010
Last Update Posted : May 18, 2022
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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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Letrozole||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2056 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2026|
Active Comparator: Letrozole for 3-2 years
Patients pre-treated with TAM for 2-3 years will receive letrozole 2,5 mg/die for 3-2 years. Total duration of early adjuvant endocrine therapy: 5 years
letrozole for 2-3 years after Tam
Experimental: Letrozole for 5 year
Patients pre-treated with TAM for 2-3 years will receive letrozole 2,5 mg/die for additional 5 years. Total duration of early adjuvant endocrine therapy: 7 years for patients pretreated with 2 years of TAM and 8 years for patients pre-treated with 3 years of TAM
Letrozole for 5 years after Tam
- Disease-free survival [ Time Frame: 6 years after the last patient enters the study ]
- Overall survival [ Time Frame: 6 years after the last patient enters the study ]
- Safety [ Time Frame: 6 years after the last patient enters the study ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- Signed informed consent prior to beginning protocol specific procedures.
- Histologically proven breast cancer at the first diagnosis with tumor stage I-II-III. Patients with histologically documented (microscopic) infiltration of the skin (pT4) will also be eligible.
- Axillary Nodal status allowed: Nx, pNo, pN1, pN2, pN3.
Postmenopausal status defined by one of the following:
- Age > 55 years with cessation of menses
- Age < 55 years but not 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 gonadotrophin 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.
- Bilateral oophorectomy
- Adjuvant TAM received for at least 2 years and not more than 3 years and 3 months. Patients treated with adjuvant chemotherapy, are required to have begun receiving TAM 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.
- ECOG/WHO performance Status 0-1. Patients must be accessible for treatment and follow-up.
- Concomitant treatment with biphosphonates are allowed and should be recorded during the trial.
- Male patients.
- Any locally advanced (T4) or inflammatory breast cancer. However, patients with microscopic infiltration of the skin (pT4) will be eligible.
- Patients with distant metastases. Any suspicious manifestation requires appropriate investigation to exclude metastases.
- Histology other than adenocarcinoma.
- Patients with previous or concomitant (not breast cancer) malignancy within the past 5 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for 5 years.
- Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- Use of hormone Replacement Therapy within four weeks before randomization.
- Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational regimen within 30 days prior to study entry.
- Concurrent treatment with any other anti-cancer therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01064635
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa, Italy, 16132|
|Principal Investigator:||Lucia Del Mastro, MD||IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Lucia Del Mastro,MD, Principal Invesitagator, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy|
|Other Study ID Numbers:||
GIM-4-LEAD ( Other Identifier: Consorzio oncotech )
2005-001212-44 ( EudraCT Number )
|First Posted:||February 8, 2010 Key Record Dates|
|Last Update Posted:||May 18, 2022|
|Last Verified:||May 2022|
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Neoplasms by Site
Steroid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs