None listed
Conditions
Brief summary
This study aims to determine whether intermittent treatment with the drug letrozole is more effective than continuous letrozole treatment in preventing the return of cancer in postmenopausal women with endocrine responsive breast cancer who have undergone 4 to 6 years of prior endocrine therapy. Who is it for? You may be eligible join this study if you are a postmenopausal woman who has had operable, non-inflammatory breast cancer but are now clinically disease-free. You must have completed 4 to 6 years of prior endocrine therapy with selective estrogen receptor modulators (SERM(s)), aromatase inhibitors (AI(s)), or a combination of both. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will take one 2.5mg letrozole tablet per day for 5 years. Participants in the other group will take letrozole 2.5mg tablets intermittently, i.e. once daily for the first 9 months of years 1 through 4, followed by 12 months in year 5. Participants will be regularly assessed over the duration of the trial to determine whether continuous or intermittent letrozole treatment is more effective in preventing the return of cancer and prolonging survival.
Interventions
The study is designed to compare the following treament arms: A) Continuous oral letrozole 2.5mg daily for 5 years, and B) Intermittent oral letrozole 2.5mg daily for the first 9 months of years 1 through 4, followed by 12 months in year 5.
Sponsors
Novartis Pharma AG
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
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.
Outcome results
None listed