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Trial Title:
Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance
NCT ID:
NCT05754528
Condition:
Breast Cancer
Conditions: Keywords:
Endocrine Therapy
Endocrine Therapy Toxicity
Dose-frequency escalation
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Standard of care administration of Endocrine therapy
Description:
Standard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day
from the start.
Arm group label:
Standard daily dosing of endocrine therapy
Intervention type:
Drug
Intervention name:
Dose-frequency escalation administration of Endocrine therapy
Description:
Endocrine therapy dose-frequency escalation. Defined as taking endocrine therapy every
other day for 1 month and then daily.
Arm group label:
Endocrine therapy dose-frequency escalation
Summary:
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.
Detailed description:
Breast cancer remains the most common cancer diagnosis and second leading cause of cancer
death among Canadian women. Close to 70% of breast cancers are hormone-dependent and
endocrine therapy is the mainstay treatment (such as tamoxifen, aromatase inhibitors and
lutenizing hormone-releasing hormone analogs). Globally, endocrine therapy has led to the
greatest benefit for breast cancer patients resulting in compelling reductions in breast
cancer recurrence and mortality rates. Tamoxifen and aromatase inhibitors (e.g.
letrozole, anastrozole and exemestane) can cause a variable degree of toxicity linked to
estrogen deprivation such as: vasomotor symptoms (hot flashes and night sweats),
arthralgia/joint stiffness, genitourinary symptoms (vaginal dryness, dysuria, urinary
incontinence, recurrent urinary tract infections and pain during sexual intercourse),
insomnia, weight gain, mood changes, cognitive dysfunction, fatigue and skin dryness. It
is well acknowledged that endocrine therapy side effects can influence treatment
adherence, compliance, and persistence. A systematic review of adjuvant endocrine
treatment found that 41 to 72% of patients did not take the correct dosage at the
prescribed frequency and 31 to 73% discontinued endocrine therapy. Treatment adherence
and persistence are key issues in breast cancer, as early cessation or reduced
compliance/adherence to hormonal therapy leads to reduced disease-free survival and
increased mortality. Despite a plethora of studies aimed at reducing the side effects of
endocrine therapy there is no clear evidence that any of them have resulted in improved
adherence/compliance/persistence. In practice, it is common to see a clinician reducing
dose-intensity or frequency when patients develop intolerable side effects from endocrine
therapy, i.e. either using 10 mg instead of 20 mg of Tamoxifen daily, or an every other
day schedule for aromatase inhibitors. However, this commonly used practice has not been
evaluated in a prospective trial. The researchers propose to conduct the world's first
prospective randomized clinical trial to evaluate a dose-frequency escalation strategy of
endocrine therapy (meaning taking the dose every other day for 1 month and then daily)
and its effects on adherence and tolerability.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with an early stage or locally advanced hormonal receptor positive breast
cancer
- Plan to receive endocrine therapy
- Able to provide oral consent
- Willing and able to complete questionnaires as per study protocol
Exclusion Criteria:
- Metastatic cancer
- Adjuvant abemaciclib
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The Ottawa Hospital Cancer Centre
Address:
City:
Ottawa
Country:
Canada
Start date:
July 28, 2023
Completion date:
July 2029
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754528
