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Treatment of Canadian 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
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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 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 postmenopausal HR+ HER2- advanced breast cancer patients. This registry incorporates an observational prospective cohort design and will enroll 320 postmenopausal HR+ HER2- advanced breast cancer women that have been previously exposed to non-steroidal aromatase inhibitor (NSAI) therapy being treated with endocrine therapy (ET) or ET in combination with targeted therapy (TT).


Condition or disease Intervention/treatment
HR+ HER2- 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 : 320 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Treatment of Canadian 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 : December 2, 2019
Estimated Study Completion Date : December 2, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cohort 1: Endocrine Therapy (ET)
HR+ HER2- postmenopausal advanced breast cancer patients with previous exposure to NSAI therapy in either the adjuvant or metastatic setting and 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- postmenopausal advanced breast cancer patients with previous exposure to NSAI therapy in either the adjuvant or metastatic setting and being treated with endocrine therapy in combination with targeted therapy
Drug: Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Number of participants with adverse events in ET and ET+TT cohorts [ Time Frame: Up to approximately 36 months ]
    To describe the incidence of adverse events, monitoring frequency and measures taken for the prevention and management of adverse events.

  2. Time to Treatment Failure (TTF) [ Time Frame: Up to approximately 36 months ]
    To describe and compare the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by TTF.

  3. Treatment Adherence and Sequencing [ Time Frame: Up to approximately 36 months ]
    To describe treatment adherence, sequence of therapies and treatment patterns used for the management of advanced breast cancer.

  4. Progression-Free Survival (PFS) [ Time Frame: Up to approximately 36 months ]
    To describe and compare the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by PFS.

  5. Overall Survival (OS) [ Time Frame: Up to approximately 36 months ]
    To describe and compare the therapeutic effectiveness of endocrine therapy (ET) and ET in combination with targeted therapy (TT) as measured by OS.

  6. Health Care Resource Utilization (HCRU) [ Time Frame: Up to approximately 24 months ]
    To describe HCRU related to management of advanced breast cancer.

  7. 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).

  8. 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:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Canadian postmenopausal women with advanced HR+ HER2- breast cancer that have been previously exposed to non-steroidal aromatase inhibitor (NSAI) therapy in either the adjuvant or metastatic setting and currently receiving endocrine therapy (ET) or ET plus targeted therapy (TT).
Criteria

INCLUSION CRITERIA:

  1. Patient has inoperable locally advanced or metastatic breast cancer.
  2. Patient has ER positive and/or PgR positive HER2-negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
  3. Patient is postmenopausal. Postmenopausal status is defined either by:

    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 (serum FSH > 40 mIU/mL and estradiol <20 pg/mL or according to the postmenopausal range defined by local laboratory).
  4. Patient has prior exposure to NSAI (letrozole or anastrozole) therapy in the adjuvant or metastatic setting. NSAI therapy does not have to be the last treatment prior to study entry. Other prior anticancer therapies, e.g. tamoxifen, fulvestrant are also allowed.
  5. 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) 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. 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:

  1. 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).
  2. Patient having received more than 3 lines of systemic therapy in the metastatic setting.
  3. Patient is participating in a clinical trial for an investigational treatment with the exception of expanded treatment protocol or access program.
  4. 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.

Information from the National Library of Medicine

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


Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Canada, British Columbia
Novartis Investigative Site Recruiting
Burnaby, British Columbia, Canada, V5G 2X6
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
Newmarket, Ontario, Canada, L3Y 2P9
Novartis Investigative Site Recruiting
Ottowa, Ontario, Canada, K1H 8L6
Novartis Investigative Site Recruiting
Sault Ste-Marie, Ontario, Canada, P6A 2C4
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
Canada, Saskatchewan
Novartis Investigative Site Recruiting
Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
Novartis Investigative Site Recruiting
Quebec, Canada, G1S 4L8
Sponsors and Collaborators
Novartis Pharmaceuticals

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: July 3, 2018
Last Verified: July 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
HR+ HER2
postmenopausal
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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Fulvestrant
Exemestane
Anastrozole
Everolimus
Tamoxifen
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