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A Randomised, Multicentre Trial Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer (REaCT-70)

Who is this study for? Patients ?70 years of age with lower risk breast cancer
What treatments are being studied? Endocrine therapy
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
Waterloo Regional Health Network
ACTIVE_NOT_RECRUITING
Kitchener
London Health Sciences Centre
ACTIVE_NOT_RECRUITING
London
Oak Valley Health
ACTIVE_NOT_RECRUITING
Markham
The Ottawa Hospital
RECRUITING
Ottawa
Allan Blair Cancer Centre
ACTIVE_NOT_RECRUITING
Regina
Saskatoon Cancer Centre
ACTIVE_NOT_RECRUITING
Saskatoon
Thunder Bay Regional Health Sciences Centre
ACTIVE_NOT_RECRUITING
Thunder Bay
Contact Information
Primary
Lisa Vandermeer, MSc
lvandermeer@ohri.ca
613-737-7700
Backup
Marta Sienkiewicz, MSc
msienkiewicz@ohri.ca
613-737-7700
Time Frame
Start Date: 2021-08-19
Estimated Completion Date: 2036-05
Participants
Target number of participants: 500
Treatments
Experimental: Omission of endocrine therapy
Omission of endocrine therapy
Active_comparator: Administration of endocrine therapy for at least 5 years
Administration of endocrine therapy for at least 5 years
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov