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

NCT04921137 | Recruiting Phase 4 DMC

• 1 other identifier: REaCT-70
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 8

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 (1)

• Hierarchical composite endpoint (OS, iDFS, MDFS, QoL)

  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.

  5 years

Secondary Outcomes (14)

• Overall survival

  5 years

• Invasive disease free survival

  5 years

• Metastatic disease free survival

  5 years

• Health-related quality of life: FACT-B plus ES

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

• Hot flashes

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

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 ≤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

You may not qualify if:

• Metastatic cancer

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (8)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

NOT YET RECRUITING

Waterloo Regional Health Network

Kitchener, Ontario, N2G 1G3, Canada

ACTIVE NOT RECRUITING

London Health Sciences Centre

London, Ontario, N6C 2R5, Canada

ACTIVE NOT RECRUITING

Oak Valley Health

Markham, Ontario, L3P 7P3, Canada

ACTIVE NOT RECRUITING

The Ottawa Hospital

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, P7B 6V4, Canada

ACTIVE NOT RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

ACTIVE NOT RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

ACTIVE NOT RECRUITING

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

Central Study Contacts

Lisa Vandermeer, MSc

CONTACT

613-737-7700; lvandermeer@ohri.ca

Marta Sienkiewicz, MSc

CONTACT

613-737-7700; msienkiewicz@ohri.ca

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): May 1, 2036
• Study Completion (Estimated): May 1, 2036
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CA (8)