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Hormone Therapy
Morning administration of endocrine therapy for Breast Cancer
Phase 4
Waitlist Available
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
Plan to receive endocrine therapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks after treatment initiation
Awards & highlights
Study Summary
This trial will compare the side effects and efficacy of taking a morning vs evening dose of endocrine therapy for early stage breast cancer patients.
Eligible Conditions
- Breast Cancer
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are planning to take endocrine therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks after treatment initiation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks after treatment initiation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Endocrine toxicity and tolerability at 12 weeks
Secondary outcome measures
Cost-effectiveness
Endocrine therapy rates of non-compliance
Endocrine toxicity and tolerability
+1 moreOther outcome measures
Rates of non-compliance to endocrine therapy
Trial Design
2Treatment groups
Active Control
Group I: Morning administration of endocrine therapyActive Control1 Intervention
Administration of endocrine therapy defined as, within one hour of the patient wake up time
Group II: Evening administration of endocrine therapyActive Control1 Intervention
Administration of endocrine therapy defined as, within one hour of the patient bed time
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
559 Previous Clinical Trials
2,785,305 Total Patients Enrolled
34 Trials studying Breast Cancer
5,014 Patients Enrolled for Breast Cancer
Marie-France Savard, MDPrincipal InvestigatorOttawa Hospital Research Institute
2 Previous Clinical Trials
340 Total Patients Enrolled
2 Trials studying Breast Cancer
340 Patients Enrolled for Breast Cancer
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do we have any new volunteers for this experiment?
"The listing for this clinical trial on clinicaltrials.gov indicates that the study is not presently recruiting patients. This particular trial was posted on June 30th, 2021 and updated September 21st, 2022. There are 2699 other trials that are actively recruiting patients at this time."
Answered by AI
What are the FDA's thoughts on endocrine therapy given at night?
"Because this is a phase 4 trial and the treatment has been approved, our team at Power estimates that it is safe to administer endocrine therapy in the evening."
Answered by AI
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