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 (Treat ER+ight)
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ClinicalTrials.gov Identifier: NCT02753686 |
Recruitment Status :
Active, not recruiting
First Posted : April 28, 2016
Last Update Posted : May 11, 2022
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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..
Condition or disease | Intervention/treatment |
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HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer | Drug: Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy |
Study Type : | Observational [Patient Registry] |
Actual Enrollment : | 438 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 2 Years |
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 |
Actual Study Start Date : | March 15, 2016 |
Estimated Primary Completion Date : | August 31, 2022 |
Estimated Study Completion Date : | August 31, 2022 |

Group/Cohort | Intervention/treatment |
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Cohort 1: Endocrine Therapy (ET)
HR+ HER2- male, female pre/postmenopausal advanced breast cancer patients being treated with endocrine therapy
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Drug: Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant |
Cohort 2: Endocrine Therapy (ET) plus Targeted Therapy (TT)
HR+ HER2- male, female pre/ postmenopausal advanced breast cancer patients being treated with endocrine therapy in combination with targeted therapy including CDK4/6 inhibitor therapy
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Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy |
- Duration on Treatment [ Time Frame: Up to approximately 24 months ]To describe the duration on treatment with ET and ET+TT by cohort subgroups defined by (but not limited to) previous treatment with a CDK4/6 inhibitor plus endocrine therapy combination and according to the current line of treatment for advanced breast cancer up to and including 3rd line
- Treatment Sequencing [ Time Frame: Up to approximately 72 months ]To describe the sequence of therapies and treatment patterns used for the management of advanced breast cancer.
- Monitoring Patterns [ Time Frame: Up to approximately 72 months ]To characterize monitoring patterns associated with complete blood count (CBC), liver function tests (LFT), electrolytes and electrocardiogram (ECG) specifically in patients treated with CDK4/6-based combinations.
- Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]To describe the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by OS.
- Health Care Resource Utilization (HCRU) [ Time Frame: Up to approximately 72 months ]To describe HCRU related to management of advanced breast cancer.
- Health Related Quality of Life (HRQoL - EORTC QLQ-C30) [ Time Frame: Up to approximately 72 months ]To describe the change in HRQoL EORTC 30 questionnaire QLQ-C30
- HRQoL BR23 [ Time Frame: Up to approximately 72 months ]To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
- Work-Related Productivity [ Time Frame: Up to approximately 72 months ]To describe the change in work-related productivity.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).
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In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study.
- 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:
- 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
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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:
- 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).
- Patient having received more than 3 lines of therapy in the metastatic setting.
- Any contraindications to the study treatments as presented in the respective Canadian Product Monographs for each therapy.
- 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.
- 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.
- Patient does not understand or is not willing to sign the informed consent for participation in the study.
- According to the judgment of the physician participation in the study may interfere with the treatment or compromise the well-being of the patient.
- Patient is expected to travel for an extensive time period or be unavailable during the study period.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753686
Canada, Alberta | |
Novartis Investigative Site | |
Calgary, Alberta, Canada, T2N 4N2 | |
Canada, British Columbia | |
Novartis Investigative Site | |
Burnaby, British Columbia, Canada, V5G 2X6 | |
Novartis Investigative Site | |
North Vancouver, British Columbia, Canada, V7L 2L7 | |
Novartis Investigative Site | |
Richmond, British Columbia, Canada, V7C 5L9 | |
Novartis Investigative Site | |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Canada, New Brunswick | |
Novartis Investigative Site | |
Moncton, New Brunswick, Canada, E1C 6Z8 | |
Novartis Investigative Site | |
Moncton, New Brunswick, Canada, E1C 8X3 | |
Canada, Ontario | |
Novartis Investigative Site | |
Cambridge, Ontario, Canada, N1R 3G2 | |
Novartis Investigative Site | |
Kingston, Ontario, Canada, K7L 5P9 | |
Novartis Investigative Site | |
Kitchener, Ontario, Canada, N2G 1G3 | |
Novartis Investigative Site | |
London, Ontario, Canada, N6A 4L6 | |
Novartis Investigative Site | |
Newmarket, Ontario, Canada, L3Y 2P9 | |
Novartis Investigative Site | |
Ottawa, Ontario, Canada, K1H 8L6 | |
Novartis Investigative Site | |
Sault Ste-Marie, Ontario, Canada, P6A 2C4 | |
Novartis Investigative Site | |
Toronto, Ontario, Canada, M2K 1E1 | |
Novartis Investigative Site | |
Toronto, Ontario, Canada, M4C 3E7 | |
Novartis Investigative Site | |
Toronto, Ontario, Canada, M5B 1W8 | |
Novartis Investigative Site | |
Windsor, Ontario, Canada, N8W 2X3 | |
Canada, Quebec | |
Novartis Investigative Site | |
Greenfield Park, Quebec, Canada, J4V 2H1 | |
Novartis Investigative Site | |
Montreal, Quebec, Canada, H3A 1A1 | |
Novartis Investigative Site | |
Montreal, Quebec, Canada, H3T 1E2 | |
Novartis Investigative Site | |
Montreal, Quebec, Canada, H4J 1C5 | |
Canada, Saskatchewan | |
Novartis Investigative Site | |
Regina, Saskatchewan, Canada, S4T 7T1 | |
Novartis Investigative Site | |
Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
Canada | |
Novartis Investigative Site | |
Quebec, Canada, G1S 4L8 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT02753686 |
Other Study ID Numbers: |
CRAD001YCA09 |
First Posted: | April 28, 2016 Key Record Dates |
Last Update Posted: | May 11, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Everolimus Letrozole Fulvestrant Anastrozole Exemestane Antineoplastic Agents Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Estrogen Receptor Antagonists |