Clinical trial NCT02753686: Treatment of Canadian Men and Pre/Peri/Post-menopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy
Official title: Treatment of Canadian Men and Pre/Postmenopausal Women With ER+ Advanced Breast Cancer in the Real-World Setting With Hormone Therapy ± Targeted Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
Keywords: HR+ HER2
pre/postmenopausal
men
advanced breast cancer
non steroidal aromatase inhibitor (NSAI) exposure
metastatic
endocrine therapy
targeted therapy
prospective
observational
registry
real world setting
adult
CRAD001
non-interventional
Canadian
CDK
cyclin dependent kinase
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Canadian men, pre/postmenopausal women with advanced HR+ HER2- breast cancer and currently receiving endocrine therapy (ET) or ET plus targeted therapy (TT).

Brief summary: 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..


Eligibility criteria: INCLUSION CRITERIA:

1. Patient is an adult, male or female ≥ 18 years old at the time of informed consent.
2. Patient has histologically and/or cytologically confirmed diagnosis of breast cancer.
3. Patient has inoperable locally advanced or metastatic breast cancer.
4. Patient has ER positive and/or PgR positive HER2-negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
5. In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study.

   1. Postmenopausal status is defined as per investigator's judgment. Definition included as guidance only:

1. 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:

1. Patient had last menstrual period within the last 12 months 2. Or if on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range 3. Or in case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.

c) Perimenopausal status is defined as neither premenopausal nor postmenopausal as per investigator's judgment.

6. Patient having received maximum one prior chemotherapy line for advanced/metastatic breast cancer is allowed.

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".

7. 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:

1. as per approved Health Canada indication OR
2. as per available expanded treatment protocol(s) only if efficacy assessments in these protocols are considered routine standard of care OR
3. 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.

   8. The decision to use ET or ET+TT has been reached prior to and independently of the current study.

   9. Patient willing to be followed according to routine standard of care practice.

   10. Signed informed consent to allow the collection of the data for the purposes of this study.

   EXCLUSION CRITERIA:
   1. Patient currently receiving chemotherapy at baseline/study entry is excluded (however patient could have received up to one line of chemotherapy in the metastatic setting prior to study entry or as a subsequent therapy after completion of ET or ET+TT treatment).
   2. Patient having received more than 3 lines of therapy in the metastatic setting.
   3. Any contraindications to the study treatments as presented in the respective Canadian Product Monographs for each therapy.
   4. Patient is participating in a clinical trial for an investigational treatment with the exception expanded treatment protocol or access program where efficacy assessments are considered routine standard of care.
   5. Patient is undergoing any treatment that is not considered standard of care as per regional policies and guidelines with the exception of treatments accessed via expanded treatment protocols or access programs.
   6. Patient does not understand or is not willing to sign the informed consent for participation in the study.
   7. According to the judgment of the physician participation in the study may interfere with the treatment or compromise the well-being of the patient.
   8. Patient is expected to travel for an extensive time period or be unavailable during the study period.

Primary outcomes:
measure: Duration on Treatment
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Treatment Sequencing
timeFrame: Up to approximately 72 months
measure: Monitoring Patterns
timeFrame: Up to approximately 72 months
measure: Overall Survival (OS)
timeFrame: Up to approximately 72 months
measure: Health Care Resource Utilization (HCRU)
timeFrame: Up to approximately 72 months
measure: Health Related Quality of Life (HRQoL - EORTC QLQ-C30)
timeFrame: Up to approximately 72 months
measure: HRQoL BR23
timeFrame: Up to approximately 72 months
measure: Work-Related Productivity
timeFrame: Up to approximately 72 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Burnaby
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: North Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Richmond
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Cambridge
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kingston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Kitchener
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Sault Ste Marie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: