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NCT Number: NCT04921137

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≤3 cm on microscope exam, OR Grade 2 and ≤2 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 node-negative (cN0 or pN0)
  • Able to provide oral consent and complete questionnaires in French or English as per study protocol

Exclusion criteria

  • Metastatic cancer

Treatment and study plan

No endocrine therapy

Other

No endocrine therapy given

Endocrine therapy

Other

Endocrine therapy given for at least 5 years

Primary outcomes

  1. Hierarchical composite endpoint (OS, iDFS, MDFS, QoL)

    Time frame: 5 years

    The primary outcome is a hierarchical composite endpoint following the WIN-ratio approach. This composite endpoint includes overall survival (OS), invasive disease free survival (iDFS), metastatic disease free survival (MDFS), quality of life (QoL), joint pain, and hot flashes.

Secondary outcomes

  1. Overall survival

    Time frame: 5 years

    Overall survival (OS) is the time from the date of surgery to the date of death due to any cause.

  2. Invasive disease free survival

    Time frame: 5 years

    Invasive disease free suvival (iDFS) is the time from the surgery until the first occurrence of invasive ipsilateral, loco-regional, contralateral and distant breast tumor recurrence or death due to any cause

  3. Metastatic disease free survival

    Time frame: 5 years

    Metastatic disease free survival (MDFS) is the time from the surgery until the first occurrence of distant breast tumor recurrence of death due to any causes

  4. Health-related quality of life: FACT-B plus ES

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Health-related quality of life is measured using the Functional Assessment of Cancer Therapy - Breast (FACT-B) plus the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES). The FACT-B has a total score of 0 to 148. FACT-ES has a total score of 0 to 184. Higher scores indicate better quality of life.

  5. Hot flashes

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Hot flashes measured using the validated FACT-B plus ES (questions ES1-3). Worsening of hot flashes will be defined as an increase by 1 of the hot flashes score compared to baseline. Improvement will be defined as a decrease of 1 of the hot flashes score compared to baseline.

  6. Joint pain

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Joint pain measured using the validated FACT-B plus ES (question BRM1). Worsening of join pain will be defined as an increase by 1 of the joint pain score compared to baseline. Improvement of join pain will be defined as a decrease of 1 of the the join pain score compared to baseline.

  7. Health-related quality of life: FACT-G

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Health-related quality of life will be measured with the Functional Assessment of Cancer Therapy - General (FACT-G) 27-item questionnaire. FACT-G scores range from 0 to 108. Higher scores indicate better quality of life.

  8. Health-related quality of life: EQ-5D-5L

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    The EQ-5D-5L questionnaire includes 6 self-reported quality of life items.

  9. Breast Cancer Specific Survival

    Time frame: 5 years

    Breast Cancer Specific Survival (BCSS) is the time from the date of surgery to the date of death from the breast cancer.

  10. Adverse events of interest

    Time frame: 5 years

    The number of participants with each adverse events of interest: bone fracture, cerebrovascular event, thromboembolic event, cardiovascular event, secondary cancer, hospitalization and death.

  11. Change in geriatric domains

    Time frame: Baseline, 1 year, 5 years

    Change in geriatric domains (e.g. functional status, comorbidities, medications, nutritional status, cognitive function, and psychosocial status) using CARG score patient tool.

  12. Adherence with prescribed endocrine therapy

    Time frame: 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Adherence with prescribed endocrine therapy will be measured by the validated Five-Item Medication Adherence Report Scale (MARS-5 score) in Arm B only.

  13. Quality-adjusted life years (QALY)

    Time frame: 5 years

    QALYs are estimated by multiplying the time spent in each health state by the corresponding utility value and summing these values across all model cycles over the time horizon.

  14. Beliefs about Medicine Questionnaire - adjuvant endocrine therapy (BMQ-AET)

    Time frame: Baseline, 26-weeks, 1-year, 2-years, 3-years, 4-years, 5-years

    Participants in arm B will complete the Beliefs about Medicine Questionnaire - adjuvant endocrine therapy (BMQ-AET). This includes 10 self-reported items.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Vandermeer, MSc

CONTACT

[email protected]

613-737-7700

Marta Sienkiewicz, MSc

CONTACT

[email protected]

613-737-7700

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Jun 10, 2021
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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