Breast CancerCARDAPACNCT02433067
Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer
A study testing Physical activity intervention in people with Breast Cancer, run by University of Franche-Comté at 1 site in France.
Trial summary
Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical activity intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 85 years
- First breast cancer HER2 + histologically confirmed,
- WHO grade Performance Index ≤1
- Normal renal function (creatinine clearance ≥ 60 ml min-1)
- Normal heart function with LVEF ≥ 50%
- Normal liver function (AST and ALT normal)
- Physical activity certificate issued by a cardiologist or an oncologist,
- Active contraception or postmenopausal
Who cannot join
- Patients aged under 18 and over 85
- Patients having no breast cancer HER2+
- Patients with metastases
- Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
- Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
- Symptomatic osteoarthritis,
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- Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease)
- Patients suffering from malnutrition (Body Mass Index (BMI) <18 kg m-2) or weight loss of over 10% during the last 3 months,
- Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity
- Pregnant or lactating Patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer
Read the detailed description
Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF).
Secondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life.
This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant).
This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms.
The programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care".
Between T3 and T6, volontary physical activity level will follow by actimetry.
- Conditions
- Breast Cancer
- Being tested
- Physical activity intervention, Control Group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity interventionOther
Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
Control GroupOther
standard oncologic care
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | - Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months Receives: Other: Physical activity intervention |
| Control group | Active comparator | - Arm B (control group) "standard oncologic care" Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction (LVEF)
evaluated with echocardiography
Measured: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
Secondary outcomes (11)
Weight and volume of left and right ventricular
evaluated with echocardiography
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Body composition
evaluated byimpedance and with tape measure and pliers of Harpenden
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Metabolic responses
evaluated with enzyme-linked immunosorbent assay (ELISA)
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Maximal voluntary quadriceps
evaluated with chair quadriceps with strain gauge
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
score of Quality of life
evaluated with questionnaire
Measured: Baseline (T0), 3 months (T3) and 6 months (T6)
score of Pain
evaluated with questionnaire
Measured: Baseline (T0), 3 months (T3) and 6 months (T6)
Fatigue
evaluated with questionnaire
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Level of physical activity
evaluated with questionnaire
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Pulmonary function (at rest and during exercise)
evaluated with respiratory functional test and maximal exercise test
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
hormonal responses
evaluated with enzyme-linked immunosorbent assay (ELISA)
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
inflammatory responses
evaluated with enzyme-linked immunosorbent assay (ELISA)
Measured: baseline (T0), 3 months (T3) and 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Franche-Comté
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue contre le cancer, France, Centre Hospitalier Universitaire de Besancon
- Responsible party
- Principal investigator, Fabienne Mougin-Guillaume, University of Franche-Comté
- Investigators
- Nathalie Meneveau, Principal investigator, University Hospital of Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433067
- Sponsor's protocol ID
- UFranche-Comte
- Acronym
- CARDAPAC
- Status last verified
- Oct 2020
- First submitted
- 14 Apr 2015
- Last updated
- 6 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Jacquinot Q, Ennequin G, Falcoz A, Sawyer D, Meneveau N, Mougin F. Exercise training decreases Neuregulin-1 concentrations in HER2-positive breast cancer patients undergoing adjuvant trastuzumab: the CARDAPAC study. Breast Cancer Res Treat. 2026 Feb 4;215(3):69. doi: 10.1007/s10549-026-07903-x.
PubMed 41636910Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.
PubMed 36211552Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.
PubMed 28629338
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
- ClinicalTrials.gov ID
- NCT02433067
- Acronym / sponsor ID
- CARDAPAC / UFranche-Comte
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Franche-ComtéUniversity, hospital or other
- Collaborators
- Ligue contre le cancer, France, Centre Hospitalier Universitaire de Besancon
- Study start
- Apr 2015
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 4 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer
Detailed description
Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by trastuzumab, the impact of three months individualized physical activity intervention (55 minutes, 3 times per week) on left ventricular ejection fraction (LVEF).
Secondary objectives: To evaluate the impact of physical activity intervention on body composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue and quality of life.
This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with HER2 overexpression confirmed histologically and eligible to receive treatment with trastuzumab (adjuvant).
This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for both arms.
The programme is organised as follows: Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard oncologic care".
Between T3 and T6, volontary physical activity level will follow by actimetry.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Other: Physical activity intervention- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months |
| Control group | Active comparator | Other: Control Group- Arm B (control group) "standard oncologic care" |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients aged 18 to 85 years
- First breast cancer HER2 + histologically confirmed,
- WHO grade Performance Index ≤1
- Normal renal function (creatinine clearance ≥ 60 ml min-1)
- Normal heart function with LVEF ≥ 50%
Key exclusion criteria (10 listed)
- Patients aged under 18 and over 85
- Patients having no breast cancer HER2+
- Patients with metastases
- Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%),
- Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis)
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 |
|---|---|---|
| Physical activity interventionPatients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week. | Other | Physical activity intervention |
| Control Groupstandard oncologic care | Other | Control group |
Primary outcome
Left Ventricular Ejection Fraction (LVEF)
Time frame: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change
evaluated with echocardiography
11 secondary outcomes
Weight and volume of left and right ventricular
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Body composition
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Metabolic responses
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Maximal voluntary quadriceps
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
score of Quality of life
Time frame: Baseline (T0), 3 months (T3) and 6 months (T6)
score of Pain
Time frame: Baseline (T0), 3 months (T3) and 6 months (T6)
Fatigue
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Level of physical activity
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Pulmonary function (at rest and during exercise)
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
hormonal responses
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
inflammatory responses
Time frame: baseline (T0), 3 months (T3) and 6 months (T6)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2020.
- Derived from this study: PubMed 41636910Jacquinot Q, Ennequin G, Falcoz A, Sawyer D, Meneveau N, Mougin F. Exercise training decreases Neuregulin-1 concentrations in HER2-positive breast cancer patients undergoing adjuvant trastuzumab: the CARDAPAC study. Breast Cancer Res Treat. 2026 Feb 4;215(3):69. doi: 10.1007/s10549-026-07903-x.
- Derived from this study: PubMed 36211552Jacquinot Q, Meneveau N, Falcoz A, Bouhaddi M, Roux P, Degano B, Chatot M, Curtit E, Mansi L, Paillard MJ, Bazan F, Chaigneau L, Dobi E, Meynard G, Vernerey D, Pivot X, Mougin F. Cardiotoxicity is mitigated after a supervised exercise program in HER2-positive breast cancer undergoing adjuvant trastuzumab. Front Cardiovasc Med. 2022 Sep 23;9:1000846. doi: 10.3389/fcvm.2022.1000846. eCollection 2022.
- Derived from this study: PubMed 28629338Jacquinot Q, Meneveau N, Chatot M, Bonnetain F, Degano B, Bouhaddi M, Dumoulin G, Vernerey D, Pivot X, Mougin F. A phase 2 randomized trial to evaluate the impact of a supervised exercise program on cardiotoxicity at 3 months in patients with HER2 overexpressing breast cancer undergoing adjuvant treatment by trastuzumab: design of the CARDAPAC study. BMC Cancer. 2017 Jun 19;17(1):425. doi: 10.1186/s12885-017-3420-4.
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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.
Nathalie Meneveau principal investigator
University Hospital of Besançon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity intervention in people with Breast Cancer, run by University of Franche-Comté 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 10 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: stopped early, as of the sponsor's last update on 6 Oct 2020. 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?
The study was stopped early. Results are not available in the source record.
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?
Left Ventricular Ejection Fraction (LVEF) (time frame: The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02433067, which also lists 3 linked publications.
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 6 Oct 2020.