HR+ HER2- Men, Pre/Postmenopausal Advanced Breast CancerTreat ER+ightNCT02753686
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
An observational study of HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer, run by Novartis Pharmaceuticals at 25 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer
- What is being tested?
- Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant and Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy
- How many people
- 440 participants
- Where
- 25 sitesCanada
- Study dates
- 15 Mar 2016to 1 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
- Postmenopausal status is defined as per investigator's judgment. Definition included as guidance only:
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- 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.
- 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.
- 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Canada25 sites
Novartis Investigative Site
Burnaby, British Columbia, V5G 2X6
Novartis Investigative Site
Calgary, Alberta, T2N 4N2
Novartis Investigative Site
Cambridge, Ontario, N1R 3G2
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2H1
Novartis Investigative Site
Kingston, Ontario, K7L 5P9
Novartis Investigative Site
Kitchener, Ontario, N2G 1G3
Novartis Investigative Site
London, Ontario, N6A 5W9
Novartis Investigative Site
Moncton, New Brunswick, E1C 6Z8
Novartis Investigative Site
Moncton, New Brunswick, E1C 8X3
Novartis Investigative Site
Montreal, Quebec, H3A 1A1
Novartis Investigative Site
Montreal, Quebec, H3T 1E2
Novartis Investigative Site
Montreal, Quebec, H4J 1C5
Novartis Investigative Site
Newmarket, Ontario, L3Y 2P9
Novartis Investigative Site
North Vancouver, British Columbia, V7L 2L7
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1S 4L8
Novartis Investigative Site
Regina, Saskatchewan, S4T 7T1
Novartis Investigative Site
Richmond, British Columbia, V7C 5L9
Novartis Investigative Site
Saskatoon, Saskatchewan, S7N 4H4
Novartis Investigative Site
Sault Ste. Marie, Ontario, P6A 2C4
Novartis Investigative Site
Toronto, Ontario, M2K 1E1
Novartis Investigative Site
Toronto, Ontario, M4C 3E7
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Novartis Investigative Site
Vancouver, British Columbia, V5Z 4E6
Novartis Investigative Site
Windsor, Ontario, N8W 2X3
About this study
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
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..
- Being tested
- Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant, Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy
- 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
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrantDrug
Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Endocrine Therapy (ET) | HR+ HER2- male, female pre/postmenopausal advanced breast cancer patients being treated with endocrine therapy Receives: 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 Receives: Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration on Treatment
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
Measured: Up to approximately 24 months
Secondary outcomes (7)
Treatment Sequencing
To describe the sequence of therapies and treatment patterns used for the management of advanced breast cancer.
Measured: Up to approximately 72 months
Monitoring Patterns
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.
Measured: Up to approximately 72 months
Overall Survival (OS)
To describe the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by OS.
Measured: Up to approximately 72 months
Health Care Resource Utilization (HCRU)
To describe HCRU related to management of advanced breast cancer.
Measured: Up to approximately 72 months
Health Related Quality of Life (HRQoL - EORTC QLQ-C30)
To describe the change in HRQoL EORTC 30 questionnaire QLQ-C30
Measured: Up to approximately 72 months
HRQoL BR23
To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
Measured: Up to approximately 72 months
Work-Related Productivity
To describe the change in work-related productivity.
Measured: Up to approximately 72 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2016 (estimated)
- Study start15 Mar 2016
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HR+ HER2- Men, Pre/Postmenopausal Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 440 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753686
- Sponsor's protocol ID
- CRAD001YCA09
- Acronym
- Treat ER+ight
- Status last verified
- Feb 2023
- First submitted
- 20 Apr 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Doyle C, Lohmann AE, Iqbal N, Henning JW, Kulkarni S, Califaretti N, Hilton J, Ferrario C, Bouganim N, Mates M, Guillemette S, Leite R, Caron MA, Thireau F, Machado A, Chia S. A Canadian real-world, multi-center, prospective, observational study assessing the treatment duration, the treatment sequence, and the overall survival for patients treated with endocrine therapy +/- targeted therapy in HR + HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2025 Apr;210(2):425-438. doi: 10.1007/s10549-024-07580-8. Epub 2025 Jan 23.
PubMed 39847203
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02753686
- Acronym / sponsor ID
- Treat ER+ight / CRAD001YCA09
- Keywords
- HR+ HER2, pre/postmenopausal, men, advanced breast cancer, non steroidal aromatase inhibitor (NSAI) exposure, metastatic, endocrine therapy, targeted therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2016 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Endocrine Therapy (ET) | – | Drug: Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrantHR+ HER2- male, female pre/postmenopausal advanced breast cancer patients being treated with endocrine therapy |
| Cohort 2: Endocrine Therapy (ET) plus Targeted Therapy (TT) | – | Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapyHR+ HER2- male, female pre/ postmenopausal advanced breast cancer patients being treated with endocrine therapy in combination with targeted therapy including CDK4/6 inhibitor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant | Drug | Cohort 1: Endocrine Therapy (ET) |
| Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy | Drug | Cohort 2: Endocrine Therapy (ET) plus Targeted Therapy (TT) |
Primary outcome
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
7 secondary outcomes
Treatment Sequencing
Time frame: Up to approximately 72 months
Monitoring Patterns
Time frame: Up to approximately 72 months
Overall Survival (OS)
Time frame: Up to approximately 72 months
Health Care Resource Utilization (HCRU)
Time frame: Up to approximately 72 months
Health Related Quality of Life (HRQoL - EORTC QLQ-C30)
Time frame: Up to approximately 72 months
HRQoL BR23
Time frame: Up to approximately 72 months
Work-Related Productivity
Time frame: Up to approximately 72 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 39847203Doyle C, Lohmann AE, Iqbal N, Henning JW, Kulkarni S, Califaretti N, Hilton J, Ferrario C, Bouganim N, Mates M, Guillemette S, Leite R, Caron MA, Thireau F, Machado A, Chia S. A Canadian real-world, multi-center, prospective, observational study assessing the treatment duration, the treatment sequence, and the overall survival for patients treated with endocrine therapy +/- targeted therapy in HR + HER2-negative advanced breast cancer. Breast Cancer Res Treat. 2025 Apr;210(2):425-438. doi: 10.1007/s10549-024-07580-8. Epub 2025 Jan 23.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HR+ HER2- Men, Pre/Postmenopausal Advanced Breast Cancer, run by Novartis Pharmaceuticals at 25 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration on Treatment (time frame: Up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.