Study of Letrozole Extension (SOLE)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 4800

Inclusion Criteria

Patients must be postmenopausal using any one of the following criteria. Because letrozole is not effective in pre- or perimenopausal patients, and may stimulate ovarian function, definitive confirmation of postmenopausal status is required:
Patients of any age who have had a bilateral oophorectomy (including radiation
castration AND amenorrheic for > 3 months)
Patients 56 years old or older. If the patient has any evidence of ovarian function,
biochemical evidence of definite postmenopausal status (defined as estradiol, LH,
and FSH in the postmenopausal range) is required.
Patients 55 years old or younger must have biochemical evidence of definite
postmenopausal status (defined as estradiol, LH, and FSH in the postmenopausal
range. Patients who have received prior LHRH analogue within the last year are
eligible if they have definite evidence of postmenopausal status as defined above.

Patients must be accessible for follow-up.

At diagnosis, patients must have had operable, non-inflammatory breast cancer.

Patients must be clinically disease-free at randomization.

Patients must have had steroid hormone receptor positive tumors (ER and/or PgR), determined by immunohistochemistry, after primary surgery and before commencement of prior endocrine therapy.

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.

There must have been no evidence of recurrent disease or distant metastatic disease at any time prior to randomization.

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.

Patients must have clinically adequate hepatic function.

Patients must have completed 4 to 6 years of prior adjuvant endocrine therapy with SERM(s), aromatase inhibitor(s), or a sequential combination of both. When calculating 4-6 years, neoadjuvant endocrine therapy should not be included.

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.

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.

Patients must have stopped hormone replacement therapy (HRT), bisphosphonates (except for treatment of bone loss), or any investigational agent at randomization. (Note: These agents are also not permitted during trial treatment.)

Pathology material from the primary tumor must be available for submission for
central review as part of the quality control measures for this protocol.

Exclusion Criteria

Patients who have had bilateral breast cancer.

Patients who have had a bone fracture due to osteoporosis at any time during the 4-6 years of prior endocrine SERM/AI therapy.

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.

Patients who have had any other non-malignant systemic diseases (cardiovascular, renal, lung, etc.) that would prevent prolonged follow-up.

Patients with psychiatric, addictive, or any disorder which compromises compliance with protocol requirements.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method