An observational study in Breast Cancer Female, sponsored by Swansea University. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-01.
Sponsored by Swansea University · Observational
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Among 757 studies in Breast Neoplasms with a site in United Kingdom — 98 open to participants now, 196 under way, 67 of them phase 3. Breast Neoplasms · United Kingdom.
Among the 757 studies in Breast Neoplasms with a site in United Kingdom, this one is the 115th largest by enrollment of the 122 observational ones that give a count, is one of 37 that started in 2017, is one of 123 observational ones, and was the 458th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →98 of the 757 studies in Breast Neoplasms with a site in United Kingdom are open now. Recruiting first, the newest first:
Zedsen Limited · Sites in United Kingdom
Ages 18–85 · Women only
University Hospitals of North Midlands NHS Trust · Sites in United Kingdom
Ages 18+ · Women only
Imperial College London · Sites in United Kingdom
Ages 16–100
BeOne Medicines · Sites in United Kingdom, United States, Australia and 13 more countries
Ages 18+
Hoffmann-La Roche · Sites in United Kingdom, United States, Argentina and 23 more countries
Ages 18+
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
757 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 1 125 · Phase 2 238 · Phase 3 229 · Phase 4 7
First in 1987; this study’s year is marked. 37 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 221 across the 613 interventional studies, 221 across the 122 observational. Of the 451 that completed or were terminated, 201 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
422 of 757 have an industry lead sponsor. The 10 most frequent:
Swansea University is the lead sponsor of 41 studies on the registry; 5 are open to participants now.
Swansea University has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
48 of the studies in Breast Neoplasms with a site in United Kingdom that are under way reach primary completion within a year, 13 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT05774951Phase 3AstraZenecaA Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy | 2027-04-20 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
Add all 48 to your calendar (.ics) → With an account.
Among the 757 studies in Breast Neoplasms with a site in United Kingdom, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study will investigate the influence of systemic adjuvant/neoadjuvant therapy (SAT: chemotherapy +/- anti-HER2 antibodies (trastuzumab +/- pertuzumab) on heart function/rhythm and cardio-respiratory fitness in recently diagnosed breast cancer patients. In some patients, SAT damages the heart (so-called 'cardiotoxicity') and this can have a serious impact on the patient's quality of life and overall survival. It has also been suggested that anticancer therapies may lead to repolarization abnormalities, QT prolongation and autonomic dysfunction, clinically reflected by an increase in HR and a reduction in heart rate variability (HRV). There is a lack of information in the literature regarding the extent and time-course of changes in cardiac function, cardiac rhythm and cardio-respiratory performance ('fitness') in these patients. Moreover, the differential influences of specific treatment regimes (e.g. SAT or SAT plus radiotherapy) and different chemotherapy drugs on cardio-respiratory performance remain unclear. A better understanding of these issues is the primary aim of this study.
This study will focus on the following:
The main research questions in this study are:
Women aged 18 years or older who have early invasive breast cancer and who are due to begin adjuvant or neoadjuvant therapy for this condition, but who are otherwise free of major cardiovascular or chronic respiratory disease and who are capable of undertaking physical exercise.
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.
Eligible participants will be women aged 18 years or over with the following characteristics:
Exclusion Criteria:
Presence of for MRI scans:
MRI scans will be requested by a clinician after the exclusion of the above contraindications. Patients unsuitable or unwilling to undergo MRI scans will be eligible for the study only if they are planned to receive trastuzumab, since this includes monitoring with MUGA scans or echocardiograms as part of routine care.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible participants will be women aged 18 years or over who have the following main characteristics: * Early invasive breast cancer (stage I-III) * Due to start SAT (adjuvant or neoadjuvant chemotherapy +/- trastuzumab +/- pertuzumab) * WHO performance status 0-2.
This study also gives Trastuzumab, Pertuzumab. No intervention listed here names it: that was found by reading the record.
Cardiac Function (stroke volume or ejection fraction)
Cardiac function during/following treatment in breast cancer patients.
Time frame: At completion of treatment, an average of 13 months
Cardiac Rhythm (heart rate variability)
Cardiac rhythm during/following treatment in breast cancer patients.
Time frame: At completion of treatment, an average of 13 months
Physical activity level (accelerometer-based activity level 'counts')
Physical activity level during/following treatment in breast cancer patients.
Time frame: At completion of treatment, an average of 13 months
Cardiorespiratory function (rate of respiratory oxygen uptake)
Cardiorespiratory function during/following treatment in breast cancer patients.
Time frame: At completion of treatment, an average of 13 months
Body mass composition (from DEXA scan)
Body fat mass and fat-free mass, and bone mineral density
Time frame: At completion of treatment, an average of 13 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Sep 2019, 25 months.
Of 1,192 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 138. This study's 25 months is below that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Swansea University