ANZ 0501 / LATER adjuvant Aromotase inhibitor Therapy for postmenopausal women with Endocrine Responsive breast cancer (LATER)
- Conditions
- Endocrine Responsive Breast CancerCancer - Breast
- Registration Number
- ACTRN12607000137493
- Lead Sponsor
- Australia and New Zealand Breast Cancer Trials Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 360
Patients must be postmenopausal, which is defined as meeting one or more of the
following criteria:
prior bilateral oophorectomy aged 60 years or more; if the patient has any clinical evidence of ovarian
function, FSH levels must be assessed and be in the postmenopausal range.
aged under 60 years:
a) with a uterus and amenorrhoea for at least 12 months prior to trial
entry (see Note 2)
b) with amenorrhoea for less than 12 months prior to trial entry and an
follicle stimulating hormone (FSH) level in the postmenopausal range
c) without a uterus and an FSH level in the postmenopausal range
Note 1: Patients who have taken hormone replacement therapy (HRT) must have ceased HRT at least 8 weeks prior to
randomisation and be free of per vagina bleeding for this time. FSH levels must be assessed
after the completion of this 8 week interval.
Note 2: Women aged under 60 years who have developed amenorrhoea after undergoing
endometrial ablation or been rendered amenorrhoeic by adjuvant chemotherapy are not eligible
unless FSH is in the postmenopausal range.
Patients must have had previous completely resected hormone responsive (oestrogen receptor (ER) and/or
Progesterone receptor (PgR) positive) invasive breast cancer determined by immunohistochemistry.
Patients must have completed a minimum of 4 years of adjuvant endocrine therapy
(Selective oestrogen receptor modulator (SERM) / Aromatase Inhibitor (AI) / Other - including ovarian function suppression, combination or sequential
Adjuvant endocrine therapy (AET), blinded trial AET) at least 12 months previously. It is anticipated that women who have completed AET much longer than 1 year ago will be entered onto the trial; the only limiting factor being that women are in good health and suitable for prolonged follow-up.
Patients who have had bilateral breast cancer are eligible provided that they have had at
least one hormone responsive tumour. All treatment for hormone non-responsive
tumours must have been completed and these tumours must have been diagnosed at
least 5 years ago.
Currently free of breast cancer.
Adequate bone marrow function, renal function and hepatic function within 6 months
prior to randomisation. Additional investigations including chest x-ray, computed tomography scan (CT), magnetic imaging scan (MRI) or positron emission tomograpy (PET)
scan should be carried out as medically indicated to rule out metastatic disease.
Bilateral mammogram performed within 12 months prior to randomisation unless the
initial surgery was a total mastectomy in which case a unilateral mammogram may be
performed. A mammogram is not required if the patient has had a bilateral mastectomy.
Bone health must be evaluated prior to randomisation and be deemed clinically as
adequate. A Bone Mineral Density Scan (DXA Scan) of hip, femoral neck, or lumbar
spine must be performed within 12 months prior to randomisation and the T-score must be greater than or equal to minus 4.0. (Note: Spinal x-rays to assess for low trauma vertebral fractures are also
strongly recommended).
Note: If a woman with osteoporosis (T-score between minus 2.5 and minus 4.0) and/or with low trauma
vertebral fractures wishes to join the trial she must receive appropriate care for osteoporosis
under the direction of her general practitioner or treating clinician.
Must be geographically accessible for follow-up.
Life expectancy of at least 10 years.
Ability to fully understand, sign and date the wr
Premenopausal patients.
Patients previously diagnosed with only hormone non-responsive early breast cancer.
Patients with any local recurrence or distant metastases of breast cancer. Any
suspicious manifestation requires appropriate investigation to exclude metastases.
Patients with non-malignant systemic diseases which would prevent prolonged followup,
or in the opinion of the investigator, would place the woman at unusual risk or
confound assessment for breast cancer events and the results of the trial.
Any previous non-breast cancer within the last 5 years, except adequately treated nonmelanoma
skin cancer, curatively treated in situ cancer of the cervix, or other solid
tumours curatively treated more than 5 years ago with no evidence of recurrence.
Intention to continue or commence systemic oestrogen and/or progesterone based
Hormone Replacement Therapy (HRT).
Osteoporotic with a T-score less than or equal to minus 4.0 within 12 months prior to randomisation.
Patients with diagnosed hypercholesterolaemia, unless currently being treated with
cholesterol lowering drugs and/or therapeutic lifestyle changes under the care of their
medical practitioner.
History of allergic reactions attributed to compounds of similar chemical or biologic
composition to Letrozole.
Any co-existing medical or psychiatric condition that would limit compliance with trial
requirements.
Treatment with non-approved or experimental drug on a different clinical trial during the
three months before randomisation.
Prior treatment on a designated trial for breast cancer if permission has not been
obtained from the sponsors of the original trial for the patient to participate in LATER.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ew breast cancer events (in local, regional or distant sites, new breast cancer in the contralateral breast)[ Patients are assessed by the clinician for new breast cancer events and survival status 6 monthly in the first year and annually thereafter until year 10 on study.];All cause mortality (death from any cause)[ Patients are assessed by the clinician for new breast cancer events and survival status 6 monthly in the first year and annually thereafter until year 10 on study.]
- Secondary Outcome Measures
Name Time Method • Cause specific mortality[ Patients are assessed by the clinician for survival status 6 monthly in the first year and annually thereafter until year 10 on study.];• Side effects of therapy[ Patients are assessed by the clinician for survival status 6 monthly in the first year and annually thereafter until year 10 on study. Side effects of therapy will be documented at one month on study via phone follow-up with the patient. The clinician will also assess the patient for side effects 6 monthly in the first year and annually thereafter until year 10 on study.]