Breast CancerPhase 4REaCT-TEMPONCT05754528
Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance
A Phase 4 study testing Dose-frequency escalation administration of Endocrine therapy in people with Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dose-frequency escalation administration of Endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 2 sitesCanada
- Study dates
- 28 Jul 2023to Feb 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Metastatic cancer
- Adjuvant abemaciclib
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital Cancer Centre
Ottawa, Ontario
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
About this study
Official title: A Pragmatic Randomised, Trial Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance (REaCT-TEMPO)
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Standard of care administration of Endocrine therapy, Dose-frequency escalation administration of Endocrine therapy
- Keywords
- Endocrine Therapy, Endocrine Therapy Toxicity, Dose-frequency escalation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care administration of Endocrine therapyDrug
Standard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day from the start.
Dose-frequency escalation administration of Endocrine therapyDrug
Endocrine therapy dose-frequency escalation. Defined as taking endocrine therapy every other day for 1 month and then daily.
| Study group | Role | What they receive |
|---|---|---|
| Standard daily dosing of endocrine therapy | Active comparator | Standard daily dosing of endocrine therapy Receives: Drug: Standard of care administration of Endocrine therapy |
| Endocrine therapy dose-frequency escalation | Experimental | Endocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily. Receives: Drug: Dose-frequency escalation administration of Endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year adherence with prescribed endocrine therapy
1-year adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value). The adherence rate at 1-year will be calculated as the number of patients who are initially enrolled in the study. Participants who do not complete the 1-year MARS-5 questionnaire will be considered as non-adherent for the primary analysis of adherence rate.
Measured: 1 year after start of endocrine therapy
Secondary outcomes (7)
Adherence rates with prescribed endocrine therapy
adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value).
Measured: Through study completion, 5 years
Persistence with prescribed endocrine therapy
Rates of persistence with prescribed endocrine therapy measured by a non-validated endocrine therapy adherence questionnaire.
Measured: Through study completion, 5 years
Endocrine toxicity and tolerability
Endocrine toxicity and tolerability measured by the change in total score and individual items of the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score, a validated subscale of the FACIT measurement system from baseline to 6 months, 1 year and 5 years following the beginning of endocrine therapy. The FACT-ES is a 46 item, 5 point Likert-type scale questionnaire that asks questions relating to physical well-being, social/family well-being, emotional well-being, functional well-being and the endocrine symptom subscale.
Measured: Through study completion, 5 years
Patient health-related quality of life
Patient Health-Related Quality of Life (HR-QoL) measured by the change in the total score and individual subscales of the validated Functional Assessment of Cancer Therapy for patients with a Breast cancer (FACT-B) questionnaire from baseline to 6 months, 1 year and 5 years following the beginning of endocrine therapy. The FACT-B is a 37 item, 5 point Likert-type scale questionnaire that asks questions relating to physical well-being, social/family well-being, emotional well-being, functional well-being and the breast cancer subscale.
Measured: Through study completion, 5 years
Endocrine therapy interruptions
Endocrine therapy interruption periods will be collected throughout study. An interruption is being defined as a pause in treatment for more than 7 days in a row.
Measured: Through study completion, 5 years
Endocrine therapy discontinuations
Endocrine therapy discontinuation rates will be collected throughout study. Discontinuation means stopping of endocrine therapy and not continuing, even on a different type.
Measured: Through study completion, 5 years
Endocrine therapy changes
Alterations made to endocrine therapy for toxicity. Meaning was there a change with the type of endocrine therapy used.
Measured: Through study completion, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start28 Jul 2023
- Primary completion25 Nov 2025
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-France Savard, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754528
- Sponsor's protocol ID
- REaCT-TEMPO
- Acronym
- REaCT-TEMPO
- Status last verified
- Jul 2026
- First submitted
- 8 Feb 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomised, Trial Evaluating an Endocrine Therapy Dose-frequency Escalation Strategy and Its Effects on Tolerability and Compliance (REaCT-TEMPO)
- ClinicalTrials.gov ID
- NCT05754528
- Acronym / sponsor ID
- REaCT-TEMPO / REaCT-TEMPO
- Conditions
- Breast Cancer
- Keywords
- Endocrine Therapy, Endocrine Therapy Toxicity, Dose-frequency escalation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 25 Nov 2025 (actual)
- Study completion
- Feb 2030 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard daily dosing of endocrine therapy | Active comparator | Drug: Standard of care administration of Endocrine therapyStandard daily dosing of endocrine therapy |
| Endocrine therapy dose-frequency escalation | Experimental | Drug: Dose-frequency escalation administration of Endocrine therapyEndocrine therapy dose-frequency escalation defined as, taking endocrine therapy every other day for 1 month and then daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Metastatic cancer
- Adjuvant abemaciclib
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care administration of Endocrine therapyStandard daily dosing of endocrine therapy. Defined as taking endocrine therapy every day from the start. | Drug | Standard daily dosing of endocrine therapy |
| Dose-frequency escalation administration of Endocrine therapyEndocrine therapy dose-frequency escalation. Defined as taking endocrine therapy every other day for 1 month and then daily. | Drug | Endocrine therapy dose-frequency escalation |
Primary outcome
1-year adherence with prescribed endocrine therapy
Time frame: 1 year after start of endocrine therapy
1-year adherence with prescribed endocrine therapy measured by the validated Five-item Medication Adherence Report Scale (MARS-5 score). The MARS-5 score can range from 5 to 25 indicating greater level of adherence. A participant will be considered adherent if they have a MARS-5 score of 23 and more (specificity and sensitivity maximized at this value). The adherence rate at 1-year will be calculated as the number of patients who are initially enrolled in the study. Participants who do not complete the 1-year MARS-5 questionnaire will be considered as non-adherent for the primary analysis of adherence rate.
7 secondary outcomes
Adherence rates with prescribed endocrine therapy
Time frame: Through study completion, 5 years
Persistence with prescribed endocrine therapy
Time frame: Through study completion, 5 years
Endocrine toxicity and tolerability
Time frame: Through study completion, 5 years
Patient health-related quality of life
Time frame: Through study completion, 5 years
Endocrine therapy interruptions
Time frame: Through study completion, 5 years
Endocrine therapy discontinuations
Time frame: Through study completion, 5 years
Endocrine therapy changes
Time frame: Through study completion, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-France Savard, MD principal investigator
Ottawa Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dose-frequency escalation administration of Endocrine therapy in people with Breast Cancer, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year adherence with prescribed endocrine therapy (time frame: 1 year after start of endocrine therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.