NCT05277935 Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib
| NCT ID | NCT05277935 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beneficência Portuguesa de São Paulo |
| Condition | Breast Neoplasm Female |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-04-22 |
| Primary Completion | 2025-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2022-04-22 with a primary completion date of 2025-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.
Eligibility Criteria
Inclusion Criteria: * Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal. * The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy. * Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study; * The patient agrees not to participate in another study with drug intervention while on treatment. * Have performance status according to the Eastern Cooperative Oncology Group * Have access to a compatible smartphone and 3G or 4G internet connection Exclusion Criteria: * Patients considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others. * Patients who have a life expectancy of \< 3 months. * Treatment with any product under investigation during the last 28 days; * Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study. * Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and/or the watch with monitoring of physical activity.
Contact & Investigator
Graziela Dal Molin, MD
PRINCIPAL INVESTIGATOR
Beneficência Portuguesa de São Paulo
Frequently Asked Questions
Who can join the NCT05277935 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm Female. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05277935 currently recruiting?
Yes, NCT05277935 is actively recruiting participants. Contact the research team at naipe@bp.org.br for enrollment information.
Where is the NCT05277935 trial being conducted?
This trial is being conducted at Rio de Janeiro, Brazil, São Paulo, Brazil, São Paulo, Brazil, São Paulo, Brazil.
Who is sponsoring the NCT05277935 clinical trial?
NCT05277935 is sponsored by Beneficência Portuguesa de São Paulo. The principal investigator is Graziela Dal Molin, MD at Beneficência Portuguesa de São Paulo. The trial plans to enroll 68 participants.