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)

• ClinicalTrials.gov Identifier: NCT02753686
• Recruitment Status: Recruiting
• First Posted: April 28, 2016
• Last Update Posted: April 21, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

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
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]
• 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

Groups and Cohorts

Group/Cohort	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 :

1. 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

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. Health Care Resource Utilization (HCRU) [ Time Frame: Up to approximately 72 months ]
   To describe HCRU related to management of advanced breast cancer.
5. 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
6. HRQoL BR23 [ Time Frame: Up to approximately 72 months ]
   To describe the change in HRQoL Breast Cancer 23 Questionnaire BR23
7. Work-Related Productivity [ Time Frame: Up to approximately 72 months ]
   To describe the change in work-related productivity.

Eligibility Criteria

• 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

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).

Criteria

INCLUSION CRITERIA:

1. Patient is an adult, male or female ≥ 18 years old at the time of informed consent.
2. Patient has histologically and/or cytologically confirmed diagnosis of breast cancer.
3. Patient has inoperable locally advanced or metastatic breast cancer.
4. Patient has ER positive and/or PgR positive HER2-negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).

5. In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study.

   1. 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:

1. as per approved Health Canada indication OR
2. as per available expanded treatment protocol(s) only if efficacy assessments in these protocols are considered routine standard of care OR

3. 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:

   1. 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).
   2. Patient having received more than 3 lines of therapy in the metastatic setting.
   3. Any contraindications to the study treatments as presented in the respective Canadian Product Monographs for each therapy.
   4. 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.
   5. 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.
   6. Patient does not understand or is not willing to sign the informed consent for participation in the study.
   7. According to the judgment of the physician participation in the study may interfere with the treatment or compromise the well-being of the patient.
   8. Patient is expected to travel for an extensive time period or be unavailable during the study period.

Contacts and Locations

Contacts

Contact: Novartis Pharmaceuticals; +41613241111

Contact: Novartis Pharmaceuticals

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

More Information

Additional Information:

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02753686
• Other Study ID Numbers: CRAD001YCA09
• First Posted: April 28, 2016
• Last Update Posted: April 21, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

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

Additional relevant MeSH terms:

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