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

NCT02753686 | Completed

• 1 other identifier: CRAD001YCA09
• Study Type: observational
• Target: 440
• Locations: 1 country
• Sites: 25

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..

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

Outcome Measures

Primary Outcomes (1)

• 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

  Up to approximately 24 months

Secondary Outcomes (7)

• Treatment Sequencing

  Up to approximately 72 months

• Monitoring Patterns

  Up to approximately 72 months

• Overall Survival (OS)

  Up to approximately 72 months

• Health Care Resource Utilization (HCRU)

  Up to approximately 72 months

• Health Related Quality of Life (HRQoL - EORTC QLQ-C30)

  Up to approximately 72 months

Study Arms (2)

Cohort 1: Endocrine Therapy (ET)

HR+ HER2- male, female pre/postmenopausal advanced breast cancer patients being treated with endocrine therapy

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

Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy

Interventions

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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:
• \. 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:
• \. 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.
• \. 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".
• \. 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (25)

Novartis Investigative Site

Calgary, Alberta, T2N 4N2, Canada

Location

Novartis Investigative Site

Burnaby, British Columbia, V5G 2X6, Canada

Location

Novartis Investigative Site

North Vancouver, British Columbia, V7L 2L7, Canada

Location

Novartis Investigative Site

Richmond, British Columbia, V7C 5L9, Canada

Location

Novartis Investigative Site

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Novartis Investigative Site

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Novartis Investigative Site

Moncton, New Brunswick, E1C 8X3, Canada

Location

Novartis Investigative Site

Cambridge, Ontario, N1R 3G2, Canada

Location

Novartis Investigative Site

Kingston, Ontario, K7L 5P9, Canada

Location

Novartis Investigative Site

Kitchener, Ontario, N2G 1G3, Canada

Location

Novartis Investigative Site

London, Ontario, N6A 5W9, Canada

Location

Novartis Investigative Site

Newmarket, Ontario, L3Y 2P9, Canada

Location

Novartis Investigative Site

Ottawa, Ontario, K1H 8L6, Canada

Location

Novartis Investigative Site

Sault Ste. Marie, Ontario, P6A 2C4, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M2K 1E1, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M4C 3E7, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5B 1W8, Canada

Location

Novartis Investigative Site

Windsor, Ontario, N8W 2X3, Canada

Location

Novartis Investigative Site

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3A 1A1, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H3T 1E2, Canada

Location

Novartis Investigative Site

Montreal, Quebec, H4J 1C5, Canada

Location

Novartis Investigative Site

Québec, Quebec, G1S 4L8, Canada

Location

Novartis Investigative Site

Regina, Saskatchewan, S4T 7T1, Canada

Location

Novartis Investigative Site

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 39847203 DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1; Neoplasm Metastasis

Interventions

Anastrozole; exemestane; Tamoxifen; Fulvestrant

Condition Hierarchy (Ancestors)

Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 28, 2016
• Study Start: March 15, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (25)