Endocrine Therapy for Older Patients with Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMarie-France Savard

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 12 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if older women (70+) with low-risk early breast cancer can safely skip hormone-blocking treatment. The goal is to see if they can avoid the side effects of this treatment without increasing the risk of cancer returning.

Research Team

Marie-France Savard

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

This trial is for patients aged 70 or older with early-stage, lower-risk hormone receptor-positive breast cancer. They must be able to consent and fill out questionnaires in French or English, have a new diagnosis of certain types of breast carcinoma, and have undergone specific surgeries without metastatic cancer.

Inclusion Criteria

My tumor is small and varies in aggressiveness based on its size.

I can give my consent and answer questions in English or French.

My breast cancer is ER+ and/or PR+, and HER2-.

See 2 more

Exclusion Criteria

My cancer has spread to other parts of my body.

Treatment Details

Interventions

Endocrine therapy (Hormone Therapy)
No endocrine therapy ()

Trial OverviewThe study is testing the necessity of endocrine therapy (ET) after surgery in older patients with low-risk breast cancer. It randomly assigns participants to either receive ET or no ET post-surgery to see if omitting ET can still effectively manage their condition.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Omission of endocrine therapyExperimental Treatment1 Intervention

Omission of endocrine therapy

Group II: Administration of endocrine therapy for at least 5 yearsActive Control1 Intervention

Administration of endocrine therapy for at least 5 years