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Hormone Therapy
Adjusted Endocrine Therapy for Breast Cancer (REaCT-TEMPO Trial)
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 5 years
Awards & highlights
REaCT-TEMPO Trial Summary
This trial evaluates a dosing strategy of endocrine therapy, taken daily or every other day, to see if it improves compliance and tolerability.
Who is the study for?
This trial is for patients with early stage or locally advanced hormone receptor-positive breast cancer who plan to receive endocrine therapy. They must be able to give oral consent and complete study questionnaires. Patients with metastatic cancer or those receiving adjuvant abemaciclib are excluded.Check my eligibility
What is being tested?
The study compares two ways of taking endocrine therapy: the usual daily dose versus starting every other day for a month, then daily. The aim is to see which method has better tolerability and adherence in participants.See study design
What are the potential side effects?
Endocrine therapy can cause hot flashes, fatigue, joint pain, mood swings, decreased sex drive, and risks of blood clots or stroke. Side effects may vary based on dosing frequency.
REaCT-TEMPO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
1-year adherence with prescribed endocrine therapy
Secondary outcome measures
Adherence rates with prescribed endocrine therapy
Endocrine therapy changes
Endocrine therapy discontinuations
+4 moreREaCT-TEMPO Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Endocrine therapy dose-frequency escalationExperimental Treatment1 Intervention
Endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.
Group II: Standard daily dosing of endocrine therapyActive Control1 Intervention
Standard daily dosing of endocrine therapy
Find a Location
Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,254 Total Patients Enrolled
34 Trials studying Breast Cancer
5,021 Patients Enrolled for Breast Cancer
Marie-France Savard, MDPrincipal InvestigatorOttawa Hospital Research Institute
2 Previous Clinical Trials
347 Total Patients Enrolled
2 Trials studying Breast Cancer
347 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is in an early stage and is hormone receptor positive.I am taking abemaciclib as a follow-up treatment.I plan to undergo hormone therapy.I can give my consent verbally.My cancer has spread to other parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Endocrine therapy dose-frequency escalation
- Group 2: Standard daily dosing of endocrine therapy
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How hazardous is it for individuals to undergo an increase in Endocrine therapy doses?
"Endocrine therapy dose-frequency escalation is rated a 3, which indicates that it has been approved by regulatory authorities."
Answered by AI
Is there presently availability for participants in this clinical trial?
"Per the records on clinicaltrials.gov, this research is actively seeking participants for enrollment. The initial posting was made on July 28th 2023 and updated as recently as August 3rd of the same year."
Answered by AI
How many participants have opted to join this trial thus far?
"Yes, the data available from clinicaltrials.gov reveals that this trial is actively in search of participants. The research was initially made public on 28th July 2023 and has since undergone an update on August 3rd 2023. It needs to recruit around 240 people at one medical facility."
Answered by AI
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