None listed
Conditions
Brief summary
This study is examining a combination of hormone treatments that may be useful as pre-surgery treatment for breast cancer. Who is it for? You may be eligible for this study if you are female, post-menopausal and have histologically confirmed newly diagnosed hormone receptor positive breast cancer. Study details Participants in this study will be randomised (by chance) to one of three groups. One group will receive the medications letrozole and promethium, another group will receive the medications tamoxifen and promethium, and the other group will receive the medication letrozole alone. The assigned treatments will be taken daily for two weeks prior to surgery. Participants will provide blood samples and consent to their cancer tissue being used for analysis, in addition to medical examination. It is hoped this research will provide fundamental evidence of the efficacy and safety of these medications in patients with early stage breast cancer
Interventions
Two weeks of preoperative systemic therapy with either 1) letrozole 2.5mg oral tablet daily, 2) letrozole 2.5mg + promethium 300mg oral tablets daily, and 3) tamoxifen 20mg + prometrium 300mg oral tablets daily, between diagnosis of breast cancer and definite surgery.
Sponsors
St Vincent's Hospital, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Post-menopausal women defined by any one of the following criteria; a) Amenorrhea >12 months at the time of diagnosis and an intact uterus, with FSH and estradiol in the postmenopausal ranges, b) prior bilateral oophorectomy, and c) FSH and estradiol levels within the postmenopausal range (as per local practice) in women aged <55years who have undergone hysterectomy. 2. Histologically confirmed ER+ and PR+ breast cancers (defined as >10% positive staining cells) 3. HER2/CEP17 ratio of <2 (as per the ASCO CAP guidelines) 4. Tumour size >1cm as measured by ultrasound and/or mammogram 5. Ability to understand all patient information and informed-consent documents, written informed consent to participate in the trial, and to avail tissue and blood samples for research
Exclusion criteria
1. Women currently on hormone therapies 2. Locally advanced/inoperable and inflammatory breast cancer 3. Clinical evidence of metastatic disease 4. Patients treated with other preoperative systemic therapies 5. Nut allergy (prometrium contains peanut oil) 6. Prior history of uterine cancer, deep vein thrombosis or pulmonary embolism.
Outcome results
None listed