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Hormone Therapy

Endocrine Therapy for Older Patients with Breast Cancer

Phase 4

Recruiting

Led By Marie-France Savard, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

New invasive estrogen and/or progesterone receptor-positive (ER+ and/or PR+), HER2-negative (HER2-) invasive breast carcinoma diagnosis as per ASCO-CAP guidelines

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks after study enrolment

Awards & highlights

Study Summary

This trial will compare the effects of omitting adjuvant ET versus standard of care in older patients with lower risk breast cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Endocrine therapy may cause hot flashes, fatigue, mood swings, reduced sex drive, bone thinning (osteoporosis), joint pain, and an increased risk of blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I had surgery to remove my breast cancer and then received radiation.

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My cancer has not spread to the lymph nodes under my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks after study enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks after study enrolment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after study enrolment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

90% treatment allocation rate

Accrual of 100 participants across 8 centres within 2 years

Participation rate of at least 60%

Secondary outcome measures

Endocrine therapy related toxicity

Health-related quality of life scores

Rate of treatment discontinuation

+1 more

Trial Design

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor

561 Previous Clinical Trials

2,785,594 Total Patients Enrolled

34 Trials studying Breast Cancer

5,161 Patients Enrolled for Breast Cancer

Marie-France Savard, MDPrincipal InvestigatorOttawa Hospital Research Institute

2 Previous Clinical Trials

487 Total Patients Enrolled

2 Trials studying Breast Cancer

487 Patients Enrolled for Breast Cancer

Media Library

Endocrine therapy (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04921137 — Phase 4

Breast Cancer Research Study Groups: Omission of endocrine therapy, Administration of endocrine therapy for at least 5 years

Breast Cancer Clinical Trial 2023: Endocrine therapy Highlights & Side Effects. Trial Name: NCT04921137 — Phase 4

Endocrine therapy (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921137 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the desired outcome of this clinical experiment?

"This clinical trial, which will be monitored for a period of two years after initiation, aims to achieve 90% patient recruitment. Secondary objectives include evaluating endocrine therapy related toxicity according to Common Terminology for Adverse Events version 5 (CTCAEv5), rate of treatment discontinuation and associated reasons why the endocrine therapy treatment was discontinued as well as health-related quality of life scores assessed by Cancer and Aging Research Group geriatric assessment tool (patient-tool) and Functional Assessment of Cancer Therapy - Endocrine Symptom Subscale (FACT-B plus ES)."

Answered by AI

What is the current recruitment rate for this research endeavor?

"Affirmative. The information available on clinicaltrials.gov demonstrates that this research initiative, initially posted on August 19th 2021, is actively recruiting participants at present. Specifically, 100 individuals are being sought from a single site for the trial's duration."

Answered by AI

What hazards, if any, are associated with No endocrine therapy?

"Based on our team's evaluation, the safety rating for No endocrine therapy is 3. This therapy has been approved after undergoing extensive clinical trials in Phase 4."

Answered by AI

Is there still availability for participants to join this research project?

"Affirmative. Data on clinicaltrials.gov confirms that this research, initially posted on August 19th 2021, is still looking for individuals to join the experiment. Specifically, 100 people need to be identified at 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Evaluating Harms and Benefits of Endocrine Therapy in Patients ≥70 Years of Age With Lower Risk Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04921137.