An interventional study of Cardio-Oncology Exercise Rehabilitation Program in Breast Cancer, sponsored by Hospital de Clinicas de Porto Alegre. Recruiting at 1 site in Brazil. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Hospital de Clinicas de Porto Alegre · Not applicable, Interventional, and Supportive care
Among 350 studies in Breast Neoplasms with a site in Brazil — 52 open to participants now, 111 under way, 61 of them phase 3. Breast Neoplasms · Brazil.
Among the 350 studies in Breast Neoplasms with a site in Brazil, this one is the 276th largest by planned enrollment of the 308 interventional ones that give a count, is one of 23 that started in 2025, is one of 78 with no phase, reaches primary completion later than 73 of the 110 other live ones, and was the 350th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →52 of the 350 studies in Breast Neoplasms with a site in Brazil are open now. Recruiting first, the newest first:
BeOne Medicines · Sites in Brazil, United States, Australia and 13 more countries
Hoffmann-La Roche · Sites in Brazil, United States, Argentina and 23 more countries
Hoffmann-La Roche · Sites in Brazil, United States, Argentina and 9 more countries
Eli Lilly and Company · Sites in Brazil, United States, Argentina and 16 more countries
D'Or Institute for Research and Education · Sites in Brazil
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 65 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
350 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 14 · Phase 2 79 · Phase 3 149 · Phase 4 4
First in 1997; this study’s year is marked. 23 started in 2025.
This study's planned enrollment of 30 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 250 across the 308 interventional studies, 251 across the 40 observational. Of the 205 that completed or were terminated, 109 (53%) have results posted.
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214 of 350 have an industry lead sponsor. The 10 most frequent:
Hospital de Clinicas de Porto Alegre is the lead sponsor of 456 studies on the registry; 61 are open to participants now.
Hospital de Clinicas de Porto Alegre has 3 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
32 of the studies in Breast Neoplasms with a site in Brazil that are under way reach primary completion within a year, 17 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT05909397Phase 3PfizerVepdegestrant (ARV-471/PF-07850327) + Palbociclib vs Letrozole + Palbociclib in ER(+)/HER2(-) Advanced Breast Cancer | 2026-12-30 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT04906395Phase 3Tolmar Inc.Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | 2027-01-30 |
| NCT06839001Phase 3Hospital do CoracaoCRYoablation for Small Tumors As Local Treatment - SIX Trial | 2027-03-01 |
Among the 350 studies in Breast Neoplasms with a site in Brazil, from their registry updates:
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Breast cancer is the most prevalent malignancy among women in Brazil, and Porto Alegre (Rio Grande do Sul) has one of the highest incidence rates in women under 50, with 165.5 cases per 100,000 women aged 40-49. Advances in cancer biology, treatment, and supportive care have improved outcomes, leading to increased survivorship. Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer, and during chemotherapy, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness.
This randomized clinical trial will enroll women diagnosed with breast cancer indicated for neoadjuvant or adjuvant chemotherapy. The study aims to characterize the clinical profile of these patients with respect to cardiovascular and functional effects of chemotherapy, and to evaluate an integrated cardio-oncology rehabilitation approach.
The investigators expect to identify the clinical profile of breast cancer patients undergoing chemotherapy and establish associations with the study variables, as well as to assess the effect of a standardized exercise program on the cardiovascular and musculoskeletal systems and quality of life. Based on these results, the study aims to propose a complementary rehabilitation program, to be offered within the public health system, alongside pharmacological treatment during and after completion of the chemotherapy cycle.
Breast cancer (BC) is highly prevalent worldwide, and in Brazil, particularly in the state of Rio Grande do Sul (RS), it is the leading cause of morbidity and mortality from malignant neoplasms among women. Five-year survival rates exceed 80% in developed countries, whereas in Brazil there is considerable variation across regions and cities. Studies indicate that Porto Alegre, the capital of RS, has one of the highest incidence rates of breast cancer among women under 50 years of age, with 165.5 cases per 100,000 women aged 40 to 49 years.
Several risk factors are associated with the development of breast cancer, including family history of the disease, use of oral contraceptives, obesity, and alcohol consumption. Notably, obesity and alcohol consumption differentially increase the risk of specific molecular subtypes of breast cancer. In addition, physical inactivity and elevated body mass index (BMI) are significant risk factors for breast cancer in postmenopausal women.
Although chemotherapy is essential in oncologic treatment, it is associated with adverse effects on the cardiovascular system. Advances in pharmacologic therapy, together with a greater understanding of disease mechanisms, have led to increased survival and improved health-related well-being among cancer patients. However, this increased survival is accompanied by greater exposure to cardiovascular risk factors and clinically unfavorable outcomes, such as cardiotoxicity caused by chemotherapeutic agents.
Cardiotoxicity, classified as acute, subacute, or chronic, is generally assessed based on changes in left ventricular ejection fraction (LVEF). Nevertheless, there is no universally accepted conceptual definition of chemotherapy-induced cardiotoxicity; definitions vary according to study design, etiology, epidemiology, and prevention strategies.
Adjuvant chemotherapy is used in up to 27% of breast cancer cases. The mechanisms underlying cardiotoxicity and the progression of cardiac dysfunction over time may be explained by: (1) increased myocardial oxidative stress; (2) disruption of mitochondrial calcium homeostasis; (3) impairment of mitochondrial energy metabolism; (4) degradation of ultrastructural proteins; (5) direct DNA damage via inhibition of topoisomerase 2β; and (6) direct cytotoxic effects on cardiac progenitor cells, reducing the heart's reparative capacity following myocardial injury.
Clinical diagnosis of cardiotoxicity cannot be limited to a simple measurement of LVEF. Evidence highlights the importance of evaluating additional outcomes beyond structural changes and reduced LVEF, including cardiac arrhythmias, coronary artery disease, blood biomarkers, and vascular function.
Cardiotoxicity and Vascular Function Endothelial cells are characterized by heterogeneous structure and function, with phenotypic variation according to their location in different organs, tissues, or blood vessel types. Positioned at the interface between blood and tissue, the endothelium plays a key role in the cardiovascular system, including regulation of vascular tone, synthesis and secretion of signaling molecules, and control of hemostasis, coagulation, inflammatory response, and atherogenesis.
Chemotherapeutic agents are generally administered via the systemic circulation. As a result, endothelial cells are among the first to be affected by these drugs, even before cardiac tissue itself. Vascular endothelial health is progressively compromised, with endothelial cells becoming increasingly vulnerable to inflammatory stressors, generation of reactive oxygen species, and reduced nitric oxide bioavailability - factors that directly contribute to the development and progression of atherosclerotic disease.
In addition to inflammatory markers and adhesion molecules, endothelial function can be assessed using brachial artery flow-mediated dilation (FMD), a technique first developed in 1992. This non-invasive method measures brachial artery diameter before and after forearm ischemia induced by inflating a cuff on the distal portion of the arm; FMD is expressed as the percentage increase in brachial artery diameter following release of the ischemic stimulus (reactive hyperemia). This vasodilation is mediated by endothelial release of nitric oxide in response to arterial wall shear stress.
Nagy et al. evaluated 22 patients with a clinical diagnosis of lymphoma treated with doxorubicin (DOX), measuring FMD before and after (at 6, 12, 24, and 48 hours) chemotherapy administration. The study's main finding was a significant reduction in FMD values (9.9±4.4% vs. 6.1±4.6%, P\<0.02). In the same line of research, other findings established significant associations between baseline FMD values and changes in LVEF at 3 months (r = 0.433; p = 0.044) and at 6 months (r = 0.581; p = 0.023) among patients who developed cardiotoxicity following anthracycline treatment. Based on these results, the authors suggest that FMD assessment may play an important role as a risk-stratification tool and an early marker of chemotherapy-induced cardiotoxicity.
Breast Cancer and Physical Exercise As noted above, several risk factors are associated with the development of breast cancer, including family history, use of oral contraceptives, obesity, and alcohol consumption, with obesity and alcohol consumption differentially increasing the risk of specific molecular BC subtypes. Physical inactivity and elevated BMI are also significant risk factors for breast cancer in postmenopausal women.
Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer. During chemotherapy treatment, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness. Studies indicate that supervised exercise programs combining aerobic and resistance training are particularly effective in reducing fatigue among women undergoing adjuvant chemotherapy.
After completion of chemotherapy, continued engagement in physical exercise remains equally beneficial. Evidence suggests that regular physical activity is associated with lower all-cause and breast-cancer-specific mortality among survivors. In addition, exercise interventions have been shown to improve self-reported cognitive function, physical fitness, fatigue, and quality of life, and to reduce depressive symptoms in breast cancer patients exposed to chemotherapy.
Given this context, this project proposes to study the clinical profile of women diagnosed with breast cancer with respect to the effects of chemotherapy treatment and the implementation of a physical exercise program on the cardiovascular system and functional capacity, through an integrated cardio-oncology rehabilitation approach, in patients treated within the Brazilian Unified Health System (SUS), cared for at a university hospital or referred from the RS public health network.
Hypotheses Null Hypothesis (H0): In women diagnosed with breast cancer, chemotherapy treatment does not produce statistically significant changes in the following clinical and laboratory outcomes: vascular function (assessed by flow-mediated dilation or ankle-brachial index); cardiac function (assessed by echocardiography or other complementary tests); functional capacity (assessed by the six-minute walk test or VO2 consumption); and inflammatory, endothelial, and cardiovascular biomarkers.
Alternative Hypothesis (H1): In women diagnosed with breast cancer, chemotherapy treatment produces statistically significant changes in the following clinical and laboratory outcomes: reduced vascular function; impaired cardiac function; decreased functional capacity; and altered levels of inflammatory, endothelial, and cardiovascular biomarkers.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo a cardio-oncology rehabilitation program with supervised exercise training sessions twice weekly at HCPA's Physical Rehabilitation Service (SFR). Assessments will be performed at baseline and at 3 and 6 months.
Behavioral: Cardio-Oncology Exercise Rehabilitation Program
Participants will receive general health and nutritional guidance at the baseline assessment and will maintain usual care, without a structured exercise program. Assessments will be performed at baseline and at 3 and 6 months, following the same schedule as the intervention group.
Structured, individualized exercise training sessions held twice weekly at HCPA's Physical Rehabilitation Service (SFR), aimed at mitigating chemotherapy-related cardiovascular and functional impairment in breast cancer patients.
Change in Left Ventricular Ejection Fraction (LVEF)
Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis
Time frame: Baseline and 6 months
Incidence of Cardiotoxicity
Development of cancer therapy-related cardiac dysfunction, including asymptomatic/subclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.
Time frame: Baseline and 6 months
Change in Electrocardiographic Abnormalities and Arrhythmias
ECG findings assessed as part of the echocardiographic evaluation. The ECG will be assessed for the following parameters: heart rate, cardiac rhythm (to identify arrhythmias), PR interval, QRS complex duration and morphology, QT/QTc interval, and ST-segment/T-wave changes.
Time frame: Baseline and 6 months
Change in Resting Blood Pressure
Measured before cardiopulmonary exercise testing (CPET)
Time frame: Baseline and 6 months
Change in Blood Pressure During Exercise
Measured during cardiopulmonary exercise testing (CPET)
Time frame: Baseline and 6 months
Change in Resting Heart Rate
Measured before cardiopulmonary exercise testing (CPET)
Time frame: Baseline and 6 months
Change in Heart Rate During Exercise
Measured during cardiopulmonary exercise testing (CPET)
Time frame: Baseline and 6 months
Change in Peak Oxygen Consumption (VO2 Peak)
Measured during cardiopulmonary exercise testing (CPET)
Time frame: Baseline and 6 months
Fatigue Pictogram (Mota, Pimenta, Fitch, 2009)
This pictorial instrument assesses fatigue intensity and fatigue interference with usual activities, each rated on a scale from 1 to 5, where higher scores indicate worse outcomes (greater fatigue intensity and greater interference with activities, respectively).
Time frame: Baseline, 3 months, and 6 months
Modified Borg CR-10 Scale (Category-Ratio 10)
This scale ranges from 0 (no exertion/dyspnea at all) to 10 (maximal/very, very severe exertion or dyspnea), where higher scores indicate worse perceived exertion or breathlessness.
Time frame: Baseline, 3 months, and 6 months
Change in Troponin
Blood biomarker (troponin)
Time frame: Baseline and 6 months
Change in BNP/NT-proBNP
Blood biomarker (BNP/NT-proBNP)
Time frame: Baseline and 6 months
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Blood biomarker (hs-CRP)
Time frame: Baseline and 6 months
Change in TNF-alpha
TNF-alpha
Time frame: Baseline and 6 months
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23)
This is a supplementary, disease-specific module used alongside the EORTC QLQ-C30. All scales and single-item measures are scored from 0 to 100 after linear transformation, following the EORTC QLQ-C30 Scoring Manual scoring algorithm. For the functional scales (Body Image, Sexual Functioning, Sexual Enjoyment, Future Perspective), higher scores indicate better functioning (better outcome). For the symptom scales/items (Systemic Therapy Side Effects, Breast Symptoms, Arm Symptoms, Upset by Hair Loss), higher scores indicate greater symptom burden (worse outcome)."
Time frame: Baseline and 6 months
Change in Lean Body Mass
Bioelectrical impedance analysis
Time frame: Baseline and 6 months
Change in Body Fat
Bioelectrical impedance analysis
Time frame: Baseline and 6 months
Change in Muscle Mass Index
Bioelectrical impedance analysis
Time frame: Baseline and 6 months
Change in Hand Grip Strength
Bilateral hand grip strength assessed by dynamometry
Time frame: Baseline and 6 months
Rehabilitation Program Adherence
Percentage of prescribed exercise sessions attended
Time frame: Throughout the 6-month study period
Reduction in Cardiovascular Adverse Events During Treatment
Number of adverse events during treatment
Time frame: Throughout the 6-month study period
Change in Ankle-Brachial Index (ABI)
Doppler ultrasound ankle-brachial index
Time frame: Baseline, 3 months, and 6 months
Plan to share: No — The study protocol establishes that participant data confidentiality and privacy will be maintained in accordance with Brazilian data protection regulations (LGPD, Law No. 13,709/2018) and national research ethics resolutions (CNS 466/2012, CNS 510/2016), with no provision in the approved protocol or informed consent form for sharing individual participant data with external researchers.
Started Dec 2025 (actual). Primary completion is estimated for Aug 2027, 20 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 20 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
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