Trial comparing treatments for Metastatic Breast Cancer
Official title Evaluating Dose Timing (Morning vs Evening) of Endocrine-based Therapies in Metastatic Breast and Prostate Cancers
ClinicalTrials.gov ID: NCT07252726
What this study is testing
- What it's testing
- The study wants to see if the trial procedures work well and to compare quality of life, side‑effects, and how well the treatment works when taken in the morning versus the evening.
- Who it's for
- It is looking for adults who have metastatic breast cancer or metastatic prostate cancer and are already on endocrine therapy.
- What's involved
- Participants will be randomly assigned to take their medication either in the morning or in the evening. They will keep a record of their doses and report on how they feel and any side‑effects.
- Time commitment
- The study lasts a few months, with regular visits and check‑ins to track medication timing, side‑effects, and quality of life.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Cohort A (Breast Cohort) Patients with metastatic hormonal receptor positive breast cancer
- Plan to receive endocrine therapy and a CDK4/6 inhibitor (either Ribociclib or Palbociclib) in the first-line metastatic setting
- Age ≥18 years
- Able to provide oral consent
- Willing and able to complete questionnaires as per study protocol Cohort A (Breast Cohort)
You likely can't join if
- Any contraindication in taking endocrine therapy and CDK4/6 inhibitor in the morning or evening
- Plan to receive abemaciclib (as this requires twice a day dosing) Cohort B (Prostate Cancer) Inclusion Criteria
- Patients with metastatic castrate sensitive prostate cancer
- Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen...
- Age ≥18 years
- Able to provide oral consent
See the full eligibility criteria
- Cohort A (Breast Cohort) Patients with metastatic hormonal receptor positive breast cancer
- Plan to receive endocrine therapy and a CDK4/6 inhibitor (either Ribociclib or Palbociclib) in the first-line metastatic setting
- Age ≥18 years
- Able to provide oral consent
- Willing and able to complete questionnaires as per study protocol Cohort A (Breast Cohort)
- Any contraindication in taking endocrine therapy and CDK4/6 inhibitor in the morning or evening
- Plan to receive abemaciclib (as this requires twice a day dosing) Cohort B (Prostate Cancer) Inclusion Criteria
- Patients with metastatic castrate sensitive prostate cancer
- Plan to receive androgen receptor pathway inhibitor (either enzalutamide, apalutamide or abiraterone acetate) in combination with androgen deprivation therapy
- Age ≥18 years
- Able to provide oral consent
- Willing and able to complete questionnaires as per study protocol Cohort B (Prostate Cancer) Exclusion Criteria
- Any contraindication in taking androgen receptor pathway inhibitor in the morning or evening
- Plan to receive darolutamide (as this requires twice a day dosing)
- Plan to receive docetaxel in combination with androgen receptor pathway inhibitor
The study team makes the final eligibility decision.
Where it is enrolling
- Kitchener, Ontario, Canada
- Ottawa, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Kitchener, Ontario, Canada; Ottawa, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.