Adjusted Endocrine Therapy for Breast Cancer
(REaCT-TEMPO Trial)

Recruiting in Palo Alto (17 mi)

Overseen byMarie-France Savard

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Ottawa Hospital Research Institute

No Placebo Group

Prior Safety Data

Approved in 12 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this randomized, pragmatic clinical trial is to evaluate an endocrine therapy dose-frequency escalation strategy and its effects on tolerability and compliance. Participants will be randomized to standard daily dosing of endocrine therapy or endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily.

Research Team

Marie-France Savard

Principal Investigator

Ottawa Hospital Research Institute

Eligibility Criteria

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.

Inclusion Criteria

My breast cancer is in an early stage and is hormone receptor positive.

I plan to undergo hormone therapy.

I can give my consent verbally.

See 1 more

Exclusion Criteria

I am taking abemaciclib as a follow-up treatment.

My cancer has spread to other parts of my body.

Treatment Details

Interventions

Endocrine therapy (Hormone Therapy)

Trial OverviewThe 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.

Participant Groups

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