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Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer

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ClinicalTrials.gov Identifier: NCT04921137
Recruitment Status : Recruiting
First Posted : June 10, 2021
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
The current standard of care for stage 1 hormone receptor-positive (HR+) breast cancer consists of breast-conserving surgery followed by adjuvant radiotherapy (RT) and endocrine therapy (ET) for at least 5 years. The benefit of adjuvant ET for older patients is mitigated because of their increase risk of death from other causes and shorter time horizon to live. Clinical and pathological factors such as low-intermediate grade, tumor size ≤2 cm, and older age have been used in a few studies to identify patients with a lower risk of recurrence that might benefit from adjuvant therapy de-escalation, i.e. omission of RT or ET. Since there is no dedicated randomized clinical trial (RCT) conducted to evaluate the omission of ET, there is clinical equipoise as to whether we can omit adjuvant ET in older patients with lower-risk early-stage breast cancer. Therefore, we propose a randomised, multicentre trial evaluating harms and benefits of endocrine therapy in patients ≥70 years of age with lower risk breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: No endocrine therapy Other: Endocrine therapy Phase 4

Detailed Description:
The current standard of care for stage 1 hormone receptor-positive (HR+) breast cancer consists of breast-conserving surgery followed by adjuvant radiotherapy (RT) and endocrine therapy (ET) for at least 5 years. The benefit of adjuvant ET for older patients is mitigated because of their increase risk of death from other causes and shorter time horizon to live. This population is also more likely to have additional comorbidities which can lead to higher treatment-related adverse events impacting quality of life and precipitating functional decline. Clinical and pathological factors such as low-intermediate grade, tumor size ≤2 cm, and older age have been used in a few studies to identify patients with a lower risk of recurrence that might benefit from adjuvant therapy de-escalation, i.e. omission of RT or ET. The body of evidence from small prospective studies, mathematical modelling study and retrospective analyses would suggest that the omission of ET in older patients with favourable HR+ breast cancer who had optimal local therapy (i.e. breast conserving surgery followed by adjuvant radiotherapy) does not compromise locoregional and survival outcomes. Since there is no dedicated randomized clinical trial (RCT) conducted to evaluate the omission of ET, there is clinical equipoise as to whether we can omit adjuvant ET in older patients with lower-risk early-stage breast cancer. Therefore, we propose a randomised, multicentre trial evaluating harms and benefits of endocrine therapy in patients ≥70 years of age with lower risk breast cancer.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised, Multicentre Trial Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer (REaCT-70)
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Omission of endocrine therapy
Omission of endocrine therapy
Other: No endocrine therapy
No endocrine therapy given

Active Comparator: Administration of endocrine therapy for at least 5 years
Administration of endocrine therapy for at least 5 years
Other: Endocrine therapy
Endocrine therapy given for at least 5 years




Primary Outcome Measures :
  1. Accrual of 100 participants across 8 centres within 2 years [ Time Frame: 2 years after study initiation ]
    The accrual of at least 100 participants at 8 centres within 2 years.

  2. Participation rate of at least 60% [ Time Frame: 2 years after study initiation ]
    A participation rate of at least 60% among participants approached.

  3. 90% treatment allocation rate [ Time Frame: 4 weeks after study enrolment ]
    At least 90% of enrolled participants receive treatment as per their allocated intervention for at least 4 weeks


Secondary Outcome Measures :
  1. Significant adverse events [ Time Frame: Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment ]
    Significant adverse events (e.g. bone fracture, stroke/transient ischemic attack, thromboembolic event, cardiac event, second cancer, hospitalization and death)

  2. Endocrine therapy related toxicity [ Time Frame: Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment ]
    Endocrine therapy (ET) related toxicity based upon Common Terminology for Adverse Events version 5 (CTCAEv5)

  3. Health-related quality of life scores [ Time Frame: Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment ]
    Health-related quality of life (HR-QoL) scores measured by the Cancer and Aging Research Group geriatric assessment (patient-tool) and the Functional Assessment of Cancer Therapy - Endocrine Symptom Subscale (FACT-B plus ES). The Cancer and Aging Research Group geriatric assessment tool (patient-tool) is utilized to capture information about a patient's medical history as well as functional, cognitive and psychosocial status. The FACT-B plus ES is used to measure the side effects and putative benefits of hormonal treatment given in breast cancer.

  4. Rate of treatment discontinuation [ Time Frame: 5 years after study enrolment ]
    The rate of endocrine therapy treatment discontinuations and reasons why the endocrine therapy treatment was discontinued.



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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New invasive estrogen and/or progesterone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) invasive breast carcinoma diagnosis as per ASCO-CAP guidelines
  • The primary tumour characteristics are either: Grade 1 and ≤5 cm on microscope exam, OR Grade 2 and ≤3 cm on microscope exam, OR Grade 3 and ≤1 cm on microscope exam
  • Treated with standard loco-regional therapy: breast conserving surgery followed by adjuvant radiotherapy OR total mastectomy
  • Axillary lymph node-negative (N0)
  • Able to provide oral consent and complete questionnaires in French or English as per study protocol

Exclusion Criteria:

  • Metastatic cancer

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): NCT04921137


Contacts
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Contact: Lisa Vandermeer, MSc 613-737-7700 ext 73039 lvandermeer@toh.ca
Contact: Marta Sienkiewicz, MSc 613-737-7700 msienkiewicz@ohri.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Marie-France Savard, MD    6137377700 ext 70170    msavard@toh.ca   
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Marie-France Savard, MD Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT04921137    
Other Study ID Numbers: REaCT-70
First Posted: June 10, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Radiation therapy
Endocrine therapy
Older patients
Adjuvant therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases