Treat ER+ight: 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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT02753686

Collaborator

(none)

438

Enrollment

Locations

77.5

Anticipated Duration (Months)

17.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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..

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

438 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Mar 15, 2016

Anticipated Primary Completion Date :

Aug 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Duration on Treatment [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

Secondary Outcome Measures

Treatment Sequencing [Up to approximately 72 months]
To describe the sequence of therapies and treatment patterns used for the management of advanced breast cancer.
Monitoring Patterns [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) [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) [Up to approximately 72 months]
To describe HCRU related to management of advanced breast cancer.
Health Related Quality of Life (HRQoL - EORTC QLQ-C30) [Up to approximately 72 months]
To describe the change in HRQoL EORTC 30 questionnaire QLQ-C30
HRQoL BR23 [Up to approximately 72 months]
To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
Work-Related Productivity [Up to approximately 72 months]
To describe the change in work-related productivity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).
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.

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.

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
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.

The decision to use ET or ET+TT has been reached prior to and independently of the current study.
Patient willing to be followed according to routine standard of care practice.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Calgary	Alberta	Canada	T2N 4N2
2	Novartis Investigative Site	Burnaby	British Columbia	Canada	V5G 2X6
3	Novartis Investigative Site	North Vancouver	British Columbia	Canada	V7L 2L7
4	Novartis Investigative Site	Richmond	British Columbia	Canada	V7C 5L9
5	Novartis Investigative Site	Vancouver	British Columbia	Canada	V5Z 4E6
6	Novartis Investigative Site	Moncton	New Brunswick	Canada	E1C 6Z8
7	Novartis Investigative Site	Moncton	New Brunswick	Canada	E1C 8X3
8	Novartis Investigative Site	Cambridge	Ontario	Canada	N1R 3G2
9	Novartis Investigative Site	Kingston	Ontario	Canada	K7L 5P9
10	Novartis Investigative Site	Kitchener	Ontario	Canada	N2G 1G3
11	Novartis Investigative Site	London	Ontario	Canada	N6A 4L6
12	Novartis Investigative Site	Newmarket	Ontario	Canada	L3Y 2P9
13	Novartis Investigative Site	Ottawa	Ontario	Canada	K1H 8L6
14	Novartis Investigative Site	Sault Ste-Marie	Ontario	Canada	P6A 2C4
15	Novartis Investigative Site	Toronto	Ontario	Canada	M2K 1E1
16	Novartis Investigative Site	Toronto	Ontario	Canada	M4C 3E7
17	Novartis Investigative Site	Toronto	Ontario	Canada	M5B 1W8
18	Novartis Investigative Site	Windsor	Ontario	Canada	N8W 2X3
19	Novartis Investigative Site	Greenfield Park	Quebec	Canada	J4V 2H1
20	Novartis Investigative Site	Montreal	Quebec	Canada	H3A 1A1
21	Novartis Investigative Site	Montreal	Quebec	Canada	H3T 1E2
22	Novartis Investigative Site	Montreal	Quebec	Canada	H4J 1C5
23	Novartis Investigative Site	Regina	Saskatchewan	Canada	S4T 7T1
24	Novartis Investigative Site	Saskatoon	Saskatchewan	Canada	S7N 4H4
25	Novartis Investigative Site	Quebec		Canada	G1S 4L8