Treatment of Canadian Men and Pre/Postmenopausal 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 |
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Recruitment Status :
Recruiting
First Posted : April 28, 2016
Last Update Posted : April 3, 2019
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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 and safety of approved cancer therapies in routine clinical practice is essential in order to optimize the management of these patients and to identify treatment and safety gaps.
This is the first Canadian study to describe real-world treatment patterns/sequencing, effectiveness and safety 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 |
|---|---|
| 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] |
| Estimated Enrollment : | 500 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 : | January 2, 2023 |
| Estimated Study Completion Date : | January 2, 2023 |
| 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 |
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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 and compare the duration on treatment with endocrine therapy (ET) and ET in combination with targeted therapy (TT) by cohort and by cohort subgroups defined by (a) previous treatment with a CDK4/6 inhibitor plus endocrine therapy combination and (b) current line of treatment for advanced breast cancer up to and including 3rd line.
- Time to Treatment Failure (TTF) [ Time Frame: Up to approximately 72 months ]To describe and compare the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by TTF.
- Treatment Adherence and Sequencing [ Time Frame: Up to approximately 72 months ]To describe treatment adherence, sequence of therapies and treatment patterns used for the management of advanced breast cancer.
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 72 months ]To describe and compare the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by PFS.
- Overall Survival (OS) [ Time Frame: Up to approximately 72 months ]To describe and compare 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 24 months ]To describe HCRU related to management of advanced breast cancer.
- Health Related Quality of Life (HRQoL - EORTC QLQ-C30 & -BR23) [ Time Frame: Up to approximately 24 months ]To describe the change in HRQoL (EORTC QLQ-C30 & -BR23).
- Work-Related Productivity [ Time Frame: Up to approximately 24 months ]To describe the change in work-related productivity.
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| 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 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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Patient is either male, or pre/postmenopausal. Postmenopausal status is defined either by:
a. Prior bilateral oophorectomy b. Or age ≥60 c. 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 (serum FSH > 40 mIU/mL and estradiol <20 pg/mL or according to the postmenopausal range defined by local laboratory). Premenopausal is defined as per investigator's judgement.
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- Patient having received maximum one prior chemotherapy line for advanced/metastatic breast cancer is allowed.
6. Patient currently receiving targeted therapy plus endocrine therapy (ET+TT) or endocrine therapy (ET) alone as per approved Health Canada indication or as per available expanded treatment protocol(s) or compassionate access program in either the 1st, 2nd or 3rd line advanced metastatic setting. Date of initiation of treatment should be a maximum of one month prior to the date of enrollment in this study. 12 months maximum prior to date of enrollment for patients receiving CDK4/6 inhibitor therapy. 1st, 2nd and 3rd line therapy in the advanced setting is defined as the first, second and third treatment respectively in the metastatic setting (which could include endocrine monotherapy, targeted therapy combination with endocrine therapy or chemotherapy).
7. The decision to use ET or ET+TT has been reached prior to and independently of the current study.
EXCLUSION CRITERIA:
- Patient 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 systemic therapy in the metastatic setting.
- Patient is participating in a clinical trial for an investigational treatment with the exception of expanded treatment protocol or access program.
- 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. This includes off-label use of any medications.
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
| Contact: Novartis Pharmaceuticals | +41613241111 | ||
| Contact: Novartis Pharmaceuticals |
| Canada, Alberta | |
| Novartis Investigative Site | Recruiting |
| Calgary, Alberta, Canada, T2N 4N2 | |
| Canada, British Columbia | |
| Novartis Investigative Site | Recruiting |
| Burnaby, British Columbia, Canada, V5G 2X6 | |
| Novartis Investigative Site | Recruiting |
| North Vancouver, British Columbia, Canada, V7L 2L7 | |
| Novartis Investigative Site | Recruiting |
| Richmond, British Columbia, Canada, V7C 5L9 | |
| Novartis Investigative Site | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 4E6 | |
| Canada, New Brunswick | |
| Novartis Investigative Site | Recruiting |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Ontario | |
| Novartis Investigative Site | Recruiting |
| Cambridge, Ontario, Canada, N1R 3G2 | |
| Novartis Investigative Site | Recruiting |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Novartis Investigative Site | Recruiting |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| Novartis Investigative Site | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Novartis Investigative Site | Recruiting |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Novartis Investigative Site | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Novartis Investigative Site | Recruiting |
| Sault Ste-Marie, Ontario, Canada, P6A 2C4 | |
| Novartis Investigative Site | Recruiting |
| Toronto, Ontario, Canada, M2K 1E1 | |
| Novartis Investigative Site | Recruiting |
| Toronto, Ontario, Canada, M4C 3E7 | |
| Novartis Investigative Site | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Novartis Investigative Site | Recruiting |
| Windsor, Ontario, Canada, N8W 2X3 | |
| Canada, Quebec | |
| Novartis Investigative Site | Recruiting |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Novartis Investigative Site | Recruiting |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Novartis Investigative Site | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Novartis Investigative Site | Recruiting |
| Montreal, Quebec, Canada, H4J 1C5 | |
| Novartis Investigative Site | Withdrawn |
| Montréal, Quebec, Canada, H3G 1L5 | |
| Canada, Saskatchewan | |
| Novartis Investigative Site | Recruiting |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Novartis Investigative Site | Recruiting |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Canada | |
| Novartis Investigative Site | Recruiting |
| Quebec, Canada, G1S 4L8 | |
Additional Information:
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02753686 History of Changes |
| Other Study ID Numbers: |
CRAD001YCA09 |
| First Posted: | April 28, 2016 Key Record Dates |
| Last Update Posted: | April 3, 2019 |
| Last Verified: | April 2019 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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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 non-interventional Canadian |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Hormones Everolimus Letrozole Tamoxifen Fulvestrant Exemestane Anastrozole Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Antineoplastic Agents, Hormonal Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Bone Density Conservation Agents Estrogen Receptor Antagonists |