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

NCT04921137 | Active Not Recruiting Phase 4

• 1 other identifier: REaCT-70
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer

Keywords

Radiation therapy; Endocrine therapy; Older patients; Adjuvant therapy

Outcome Measures

Primary Outcomes (3)

• Accrual of 100 participants across 8 centres within 2 years

  The accrual of at least 100 participants at 8 centres within 2 years.

  2 years after study initiation

• Participation rate of at least 60%

  A participation rate of at least 60% among participants approached.

  2 years after study initiation

• 90% treatment allocation rate

  At least 90% of enrolled participants receive treatment as per their allocated intervention for at least 4 weeks

  4 weeks after study enrolment

Secondary Outcomes (4)

• Significant adverse events

  Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment

• Endocrine therapy related toxicity

  Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment

• Health-related quality of life scores

  Baseline, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years and 5 years after study enrolment

• Rate of treatment discontinuation

  5 years after study enrolment

Study Arms (2)

Omission of endocrine therapy

EXPERIMENTAL

Omission of endocrine therapy

Other: No endocrine therapy

Administration of endocrine therapy for at least 5 years

ACTIVE COMPARATOR

Administration of endocrine therapy for at least 5 years

Other: Endocrine therapy

Interventions

No endocrine therapy OTHER

No endocrine therapy given

Omission of endocrine therapy

Endocrine therapy OTHER

Endocrine therapy given for at least 5 years

Administration of endocrine therapy for at least 5 years

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Metastatic cancer

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (7)

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

London Health Sciences Centre

London, Ontario, N6C 2R5, Canada

Location

Oak Valley Health

Markham, Ontario, L3P 7P3, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

Location

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (3)

• Savard MF, Clemons M, Hutton B, Jemaan Alzahrani M, Caudrelier JM, Vandermeer L, Liu M, Saunders D, Sienkiewicz M, Stober C, Cole K, Shorr R, Arnaout A, Chang L. De-escalating adjuvant therapies in older patients with lower risk estrogen receptor-positive breast cancer treated with breast-conserving surgery: A systematic review and meta-analysis. Cancer Treat Rev. 2021 Sep;99:102254. doi: 10.1016/j.ctrv.2021.102254. Epub 2021 Jun 19.

  PMID: 34242928 BACKGROUND

• Alzahrani M, Clemons M, Chang L, Vendermeer L, Arnaout A, Larocque G, Cole K, Hsu T, Saunders D, Savard MF. Management Strategies for Older Patients with Low-Risk Early-Stage Breast Cancer: A Physician Survey. Curr Oncol. 2021 Dec 21;29(1):1-13. doi: 10.3390/curroncol29010001.

  PMID: 35049675 BACKGROUND

• Savard MF, Alzahrani MJ, Saunders D, Chang L, Arnaout A, Ng TL, Brackstone M, Vandermeer L, Hsu T, Awan AA, Cole K, Larocque G, Clemons M. Experiences and Perceptions of Older Adults with Lower-Risk Hormone Receptor-Positive Breast Cancer about Adjuvant Radiotherapy and Endocrine Therapy: A Patient Survey. Curr Oncol. 2021 Dec 8;28(6):5215-5226. doi: 10.3390/curroncol28060436.

  PMID: 34940075 BACKGROUND

Related Links

• The Rethinking Clinical Trials (REaCT) website

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Marie-France Savard, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 10, 2021
• Study Start: August 19, 2021
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

CA (7)