Breast CancerPEP-NAT-BNCT01754597
Natriuretic Peptide Concentrations of B-type (BNP) During Anesthesia in Patients Previously Sensitized to Anthracyclines
A study testing Dosage of B-type natriuretic peptide (NT-proBNP) in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
Trial summary
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dosage of B-type natriuretic peptide (NT-proBNP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women over 18 years with effective contraceptive method (if applicable)
- NT-proBNP <125 pg / ml
- ASA 1 or 2,
- Breast cancer histologically proven
- Mastectomy or lumpectomy
- Neoadjuvant chemotherapy with anthracyclines in 6 months or received no chemotherapy with anthracyclines,
- Patients who received the briefing and signed the informed consent
- Patients affiliated to a social security system.
Who cannot join
- Patients for whom the maintenance of general anesthesia does not use halogenated.
- Renal impairment: Creatinine clearance <60 ml / min,
- Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
- Presence of a cardiopathy
- Pregnant Women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer.
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Read the detailed description
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes. In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
- Conditions
- Breast Cancer
- Being tested
- Dosage of B-type natriuretic peptide (NT-proBNP)
- Keywords
- Anesthesia
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dosage of B-type natriuretic peptide (NT-proBNP)Other
NT-proBNP concentration assessed at the following time points :
- T0: before induction of general anesthesia, NT-proBNP measurement
- T1: 30 minutes after induction of general anesthesia
- T2: at the end of the procedure
- T3: in the postoperative period, 6 hours after the end of the procedure
- T4: in the postoperative period, 24 hours after the end of the procedure
| Study group | Role | What they receive |
|---|---|---|
| Participants not previously treated with anthracyclines | Other | No anthracycline treatment in the 6 months prior to inclusion. Receives: Other: Dosage of B-type natriuretic peptide (NT-proBNP) |
| Participants previously treated with anthracyclines | Other | Not described Receives: Other: Dosage of B-type natriuretic peptide (NT-proBNP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Concentration of NT-proBNP
Mean concentration of NT-proBNP measured before surgery.
Measured: Before breast surgery
Concentration of NT-proBNP at the End of Intervention
Mean concentration of NT-proBNP measured at the end of intervention
Measured: At the end of breast surgery
Post-operative Concentration of NT-proBNP
Mean concentration of NT-proBNP measured 24 hours after breast surgery
Measured: 24 hours after breast surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2012 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This feasibility study will describe the evolution of NT-ProBNP during general anesthesia in patients undergoing surgery for breast cancer, depending on whether or not they have previously been treated with anthracyclines. The data collected in this study will be used later in a clinical trial comparing the occurrence of subclinical heart failure during breast cancer surgery under general anesthesia, depending on whether patients have been sensitized to anthracyclines.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Bergonié
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GEKIERE Jean Pierre, MD, Study chair, Institut Bergonié
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01754597
- Sponsor's protocol ID
- IB2009-39
- Acronym
- PEP-NAT-B
- Status last verified
- Sep 2025
- First submitted
- 6 Nov 2012
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution Natriuretic Peptide Concentrations of B-type (BNP) During General Anesthesia Under Propofol and Sevoflurane Association in Patients Previously Sensitized to Anthracyclines. Pilot Study in Patients Operated on for Breast Cancer.
- ClinicalTrials.gov ID
- NCT01754597
- Acronym / sponsor ID
- PEP-NAT-B / IB2009-39
- Conditions
- Breast Cancer
- Keywords
- Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Institut BergoniéUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Dec 2012 (estimated)
- Results
- Posted 1 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Detailed description
The cardiotoxicity of anthracyclines chemotherapy remains a major problem, despite clinical and echocardiographic monitoring. In the case of treatment for breast cancer, surgery requiring general anesthesia may follow chemotherapy. Although a possible interaction between general anesthetics and anthracyclines on systolic function is only rarely mentioned, some cases of heart failure and / or conduction disturbances peranesthésique were observed in patients treated or previously treated with anthracyclines. The determination of concentration of BNP is a diagnostic tool used in the detection of heart failure and acute coronary syndromes. In fact, it is one of the most sensitive markers of impaired myocardial function, and an increase in interest rates may precede any other biological changes. In a patient who received anthracycline, although it remains asymptomatic elevation of NT-proBNP concentration may persist for some months after exposure, and that, whatever the doses received. The question of a possible synergism between cardiotoxic anthracyclines and anesthetic agents arises. Given its minimally invasive nature and its diagnostic value, the BNP assay might thus allow to highlight a possible subclinical deficiency. To our knowledge, there is very little data regarding a possible synergism between cardiotoxic anthracyclines and anesthetic agents.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This feasibility study will describe the evolution of NT-ProBNP during general anesthesia in patients undergoing surgery for breast cancer, depending on whether or not they have previously been treated with anthracyclines. The data collected in this study will be used later in a clinical trial comparing the occurrence of subclinical heart failure during breast cancer surgery under general anesthesia, depending on whether patients have been sensitized to anthracyclines.
| Arm | Type | Receives |
|---|---|---|
| Participants not previously treated with anthracyclines | Other | Other: Dosage of B-type natriuretic peptide (NT-proBNP)No anthracycline treatment in the 6 months prior to inclusion. |
| Participants previously treated with anthracyclines | Other | Other: Dosage of B-type natriuretic peptide (NT-proBNP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Women over 18 years with effective contraceptive method (if applicable)
- NT-proBNP <125 pg / ml
- ASA 1 or 2,
- Breast cancer histologically proven
- Mastectomy or lumpectomy
Key exclusion criteria (5 listed)
- Patients for whom the maintenance of general anesthesia does not use halogenated.
- Renal impairment: Creatinine clearance <60 ml / min,
- Patients who for reasons psychological, social, family or geographical could not be treated or monitored regularly according to the criteria of the study, patients deprived of liberty or under guardianship.
- Presence of a cardiopathy
- Pregnant Women
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 |
|---|---|---|
| Dosage of B-type natriuretic peptide (NT-proBNP)NT-proBNP concentration assessed at the following time points : * T0: before induction of general anesthesia, NT-proBNP measurement * T1: 30 minutes after induction of general anesthesia * T2: at the end of the procedure * T3: in the postoperative period, 6 hours after the end of the procedure * T4: in the postoperative period, 24 hours after the end of the procedure | Other | Participants not previously treated with anthracyclines, Participants previously treated with anthracyclines |
Primary outcome
Pre-operative Concentration of NT-proBNP
Time frame: Before breast surgery
Mean concentration of NT-proBNP measured before surgery.
Concentration of NT-proBNP at the End of Intervention
Time frame: At the end of breast surgery
Mean concentration of NT-proBNP measured at the end of intervention
Post-operative Concentration of NT-proBNP
Time frame: 24 hours after breast surgery
Mean concentration of NT-proBNP measured 24 hours after breast surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
GEKIERE Jean Pierre, MD study chair
Institut Bergonié
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dosage of B-type natriuretic peptide (NT-proBNP) in people with Breast Cancer, run by Institut Bergonié at 1 site in France.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre-operative Concentration of NT-proBNP (time frame: Before breast surgery). The study lists 3 primary outcomes in all. 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 1 Oct 2025.