SOLE: Study Of Letrozole Extension in post-menopausal women with breast cancer

Phase 3

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN43286545
• Lead Sponsor: European Institute of Oncology (IEO) (Italy)

Brief Summary

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29158011 results (added 10/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-03
• Study Completion: 2018-12-31
• Last Update Posted: 15 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 4884

Inclusion Criteria

1. Patients must be post-menopausal; definitive confirmation of post-menopausal status is required
2. Patients must be accessible for follow-up
3. At diagnosis, patients must have had operable, non-inflammatory breast cancer
4. Patients must be clinically disease-free at randomisation
5. Patients must have had steroid hormone receptor positive tumours (oestrogen receptor [ER] and/or progesterone receptor [PgR]), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy
6. Following primary surgery, eligible patients must have had evidence of lymph node involvement either in the axillary or internal mammary nodes, but not supraclavicular nodes
7. There must have been no evidence of recurrent disease or distant metastatic disease at any time prior to randomisation
8. Patients must have had proper local treatment including surgery with or without radiotherapy for primary breast cancer with no known clinical residual loco-regional disease
9. Patients must have clinically adequate hepatic function
10. Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with SERMs, AI or a sequential combination of both. When calculating 4 - 6 years, neoadjuvant endocrine therapy should not be included.
11. Patients must have stopped prior endocrine SERM/AI therapy, and must be randomized within 12 months (1 year) of the last dose of prior endocrine SERM/AI therapy
12. 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
13. Patients must have stopped hormone replacement therapy (HRT), bisphosphonates (except for treatment of bone loss), or any investigational agent at randomisation
14. Pathology material from the primary tumour must be available for submission for central review as part of the quality control measures for this protocol
15. Written informed consent (IC) must be signed and dated by the patient and the investigator prior to randomisation
16. Written consent to pathology material submission, indicating the patient has been informed of and agrees to tissue material use, transfer and handling, must be signed and dated by the patient and the investigator prior to randomisation
17. Females, no defined age limits

Exclusion Criteria

1. Patients who have had bilateral breast cancer
2. Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy
3. Patients who have had any 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
4. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up
5. Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Disease-free survival (DFS) is defined as the time from randomisation to local (including invasive recurrence restricted to the breast after breast conserving treatment), regional or distant relapse, contralateral breast cancer, appearance of a second (non-breast) malignancy, or death from any cause, whichever occurs first. Appearance of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) either in the ipsilateral or in the contralateral breast will not be considered as an event for DFS.<br><br> Event driven analyses - final analysis requires 647 events, interim analysis at 259 and 453 events.<br>