A Phase 3 interventional study of Enalapril in Breast Cancer and Non Hodgkin Lymphoma, sponsored by South Tees Hospitals NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-20.
Sponsored by South Tees Hospitals NHS Foundation Trust · Phase 3, Interventional, and Prevention
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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 403rd largest by enrollment of the 613 interventional ones that give a count, is one of 37 that started in 2017, is one of 220 in phase 3, and was the 457th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 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 2,398 Breast Neoplasms studies recruiting now, 1,569 (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 · all sexes · 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 111 is above the median of 72 across 10,900 interventional 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:
South Tees Hospitals NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 3 are open to participants now.
South Tees Hospitals NHS Foundation Trust has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
49 of the studies in Breast Neoplasms with a site in United Kingdom that are under way reach primary completion within a year, 14 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 |
| 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 |
| 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 |
Add all 49 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.
PROACT will establish the effectiveness of the angiotensin-converting enzyme inhibitor (ACEI) enalapril maleate (enalapril) in preventing cardiotoxicity in patients with breast cancer and non-Hodgkin lymphoma undergoing adjuvant epirubicin-based chemotherapy.
PROACT is a phase 3 randomised, open label, blinded endpoint, superiority trial of enalapril to prevent anthracycline-induced in patients treated for breast cancer and lymphoma.
Anthracyclines used in the treatment of breast cancer cause damage to heart muscle cells; this results in cell death (cardiotoxicity). In UK contemporary practice, epirubicin is the most frequently used anthracycline.
Patients due to receive adjuvant anthracycline chemotherapy (planned epirubicin dose >300mg/m2) for breast cancer at four specialist centres in the North of England will be invited to participate. 170 eligible patients will be randomised in a 1:1 ratio, to either enalapril plus usual care or to usual care. Enalapril will be commenced prior to the first anthracycline dose, titrated to a maximum tolerated dose, and continued during chemotherapy. Chemotherapy will continue per usual care; typically six treatment cycles. Patients will have a blood test performed at the end of each chemotherapy cycle to measure cardiac troponin, and at one month following the last epirubicin dose. Investigators and patients will be blinded to the troponin results. Patients will have an echocardiogram at baseline and following their chemotherapy; they will be assessed in a blinded manner by a central Core Laboratory.
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.
OR
Adult patients with histopathologically confirmed non-Hodgkin lymphoma (NHL), planned to receive 6 cycles of R-CHOP or CHOP (total planned dose 300mg/m2 doxorubicin) chemotherapy**
Exclusion Criteria:
judgement by the Investigator that the patient should not participate in the study, for example, if the patient is unlikely to comply with study procedures, restrictions, and requirements.
*\<50% as defined by Simpson's biplane method; if absolute measurements are not possible, then a visually normal assessment of LVEF is acceptable for inclusion.
**White coat hypertension is more common, and should be ruled out by an ambulatory blood pressure monitor
***Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline. Adequate methods of contraception are those that can achieve a failure rate of less than
1% per year when used consistently and correctly, such methods include:
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
progestogen-only hormonal contraception associated with inhibition of ovulation
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.
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.
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.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
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.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Enalapril
Enalapril is an Angiotensin Converting Enzyme (ACE) inhibitor which supresses the reninangiotensin-aldosterone system resulting in increased plasma renin activity and decreased aldosterone secretion
Cardiac troponin T release
Cardiac troponin T release during anthracycline treatment
Time frame: One month after last dose of anthracycline
Cardiac function
Cardiac function assessed by echocardiogram
Time frame: One month after last dose of anthracycline
Adherence to enalapril
Ability of participant to adhere to enalapril
Time frame: One month after last dose of anthracycline
Adverse Events / Reactions
Number and severity of Adverse Events and Reactions
Time frame: One month after last dose of anthracycline
Anxiety or distress related to trial participation
Anxiety or distress related to trial participation
Time frame: One month after last dose of anthracycline
Cancer and chemotherapy outcomes
Cancer and chemotherapy outcomes in the population under study
Time frame: One month after last dose of anthracycline
Cardiac troponin I release
cardiac troponin I release during anthracyline treatment
Time frame: One month after last dose of anthracycline
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Oct 2017 to primary completion in Aug 2023, 70 months.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's 70 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Enalapril
South Tees Hospitals NHS Foundation Trust