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Although randomized controlled trials (RCTs) provide evidence of efficacy, generalization of these results to patients in the real-world setting is challenging, given RCTs are conducted in highly selected patient populations.
An understanding of the effectiveness of approved cancer therapies in routine clinical practice is essential in order to optimize the management of these patients and to identify treatment and monitoring gaps.
This is the first Canadian study to describe real-world treatment patterns/sequencing, effectiveness and monitoring for men and pre/postmenopausal HR+ HER2- advanced breast cancer patients. This registry incorporates an observational prospective cohort design and will enroll 500 men and pre/postmenopausal HR+ HER2- advanced breast cancer women that have been exposed to endocrine therapy (ET) or ET in combination with targeted therapy (TT) including patients receiving CDK4/6 inhibitor therapy combinations..
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Inclusion and exclusion criteria
INCLUSION CRITERIA:
Patient is an adult, male or female ≥ 18 years old at the time of informed consent.
Patient has histologically and/or cytologically confirmed diagnosis of breast cancer.
Patient has inoperable locally advanced or metastatic breast cancer.
Patient has ER positive and/or PgR positive HER2-negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study.
Prior bilateral oophorectomy 2. Or age ≥60 3. Or age < 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression), and FSH and estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age < 60, then FSH and plasma estradiol levels should be in postmenopausal range per local normal range.
b) Premenopausal status is defined as per investigator's judgment. Definition included as guidance only:
c) Perimenopausal status is defined as neither premenopausal nor postmenopausal as per investigator's judgment.
Note: A chemotherapy line in advanced disease is an anticancer regimen(s) that contains at least 1 cytotoxic chemotherapy agent and given for 21 days or longer. If a cytotoxic chemotherapy regimen was discontinued for a reason other than disease progression and lasted less than 21 days, then this regimen does not count as a "prior line of chemotherapy".
Patient receiving targeted therapy plus endocrine therapy (ET+TT) in either the 1st, 2nd or 3rd line or endocrine therapy alone (ET) in either the 2nd or 3rd line advanced metastatic setting:
as per approved Health Canada indication OR
as per available expanded treatment protocol(s) only if efficacy assessments in these protocols are considered routine standard of care OR
as per available compassionate / expanded access program
Notes: 1. Date of initiation of treatment should be a maximum of 12 months prior to the date of enrollment in this study for patients receiving CDK4/6 inhibitor therapy based combinations. Date of initiation of treatment should be a maximum of 1 month prior to the date of enrollment in this study for patients receiving all other endocrine monotherapies or combination therapies. 2. 1st, 2nd and 3rd line therapy in the advanced setting is defined as the first, second and third treatment received respectively in the metastatic setting (which could include endocrine monotherapy, targeted therapy combination with endocrine therapy or chemotherapy). 3. 3. Patients enrolled in the ET cohort must have received a prior CDK4/6 inhibitor for advanced/metastatic breast cancer. Patients who have received two subsequent lines of CDK4/6 inhibitor therapy are allowed.
The decision to use ET or ET+TT has been reached prior to and independently of the current study.
Patient willing to be followed according to routine standard of care practice.
Signed informed consent to allow the collection of the data for the purposes of this study.
EXCLUSION CRITERIA:
440 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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