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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
Sponsor:
Information provided by (Responsible Party):
Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Description
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Brief Summary:

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

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2056 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Letrozole
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
 Drug: Letrozole
Letrozole for 5 years after Tam


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: 6 years after the last patient enters the study ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 6 years after the last patient enters the study ]
  2. Safety [ Time Frame: 6 years after the last patient enters the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • 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.

EXCLUSION CRITERIA

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, Italy, 16132
Sponsors and Collaborators
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Investigators
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Principal Investigator: Lucia Del Mastro, MD IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lucia Del Mastro,MD, Principal Invesitagator, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier: NCT01064635    
Other Study ID Numbers: CDR0000665188
GIM-4-LEAD ( Other Identifier: Consorzio oncotech )
2005-001212-44 ( EudraCT Number )
EU-21003
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Keywords provided by Lucia Del Mastro,MD, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
 stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs