IBCSG 35-07 / BIG 1-07 : Study of Letrozole Extension (SOLE). Letrozole in Preventing the Return of Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer.

Phase 3

Completed

• Conditions: Endocrine Responsive Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12608000243314
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-12
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4800

Inclusion Criteria

Patients must be postmenopausal. Have had operable, non-inflammatory breast cancer at diagnosis. Must be clinically disease-free at randomisation. Have had ER and/or PgR positive tumours after primary surgery and before commencement of prior endocrine therapy. Following primary surgery, patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes. Must have had proper local treatment including surgery with/without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease. Patients must have clinically adequate hepatic function. Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with selective estrogen receptor modulators (SERM(s)), aromatase inhibitors(AI(s)), or a sequential combination of both (neoadjuvant endocrine therapy should not be included). Patients must have stopped prior endocrine SERM/AI therapy, and must be randomised within 12 months of the last dose of prior endocrine SERM/AI therapy. Patients may have received any type of prior adjuvant therapy, including but not limited to neoadjuvant chemotherapy, neoadjuvant endocrine therapy, adjuvant chemotherapy, trastuzumab, ovarian ablation, GnRH analogues, lapatinib. Pathology material from the primary tumour must be available for submission for central review. Written Informed Consent, and written consent to pathology material submission. Must be accessible for follow-up.

Exclusion Criteria

Evidence of recurrent disease or distant metastatic disease at any time prior to randomisation. Patients who have had bilateral breast cancer. Bone fracture due to osteoporosis at any time during the 4-6 years of prior SERM/AI therapy. Previous or concomitant malignancy EXCEPT adequately treated: basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma. Other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up. Psychiatric, addictive, or any disorder which compromises compliance with protocol rquirements. Concurrent hormone replacement therapy, bisphosphonates (except for treatment of bone loss), or any investigational agent at randomisation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS). DFS is defined as the time from randomisation to local, regional, or distant relapse, contralateral breast cancer, appearance of a second (non-breast) malignancy, or death from any cause, whichever occurs first.[Two interim and one final analyses are planned. The target number of events for the final analysis is 647, and interim analyses are planned after 40% and 70% information (259 and 453 events observed respectively).]