Breast CancerPROTECT-03NCT04638712
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
A study testing Microbiopsy sample and Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of : one group of patients receiving anthracyclines and taxanes a second group of patients receiving anthracyclines, taxanes and trastuzumab. 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?
- Microbiopsy sample and Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2020to 20 May 2021
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For group 1 without trastuzumab :
- Patients must be ≥ 18 years old
- Patients with breast cancer stage I to III
- Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab
- Patients must have a social security coverage
- Patients able to speak, read and understand French
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- For group 2 with trastuzumab :
- Patients must be ≥ 18 years old
- Patients with breast cancer grade I to III
- Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, with trastuzumab
- Patients must have a social security coverage
- Patients able to speak, read and understand French
Who cannot join
- History of cancer
- Previous chemotherapy
- Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease)
- Pacemaker implantation
- Contraindication to physical condition evaluation
- Contraindication to local anesthesia required for microbiopsy
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- Patients < 18 years old or patients ≥ 18 years old under guardianship, or supervision
- Psychiatric, musculoskeletal or neurologic disorders
- Women that are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country.
About this study
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :
- one group of patients receiving anthracyclines and taxanes
- a second group of patients receiving anthracyclines, taxanes and trastuzumab.
- Conditions
- Breast Cancer
- Being tested
- Microbiopsy sample, Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiopsy sampleOther
before and after chemotherapy
Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity levelOther
before and after chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 without trastuzumab | Other | Not described Receives: Other: Microbiopsy sample; Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level |
| Group 2 with trastuzumab | Other | Not described Receives: Other: Microbiopsy sample; Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in vastus lateralis cross-sectional area
Measured from muscle microbiopsy sample
Measured: Between Week 18 and 24 after chemotherapy
Secondary outcomes (5)
Alteration of patients body composition
Assessment using bio-impedance analysis
Measured: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients strength
Assessment of maximal isometric muscle strength for knee extensors measured with force sensors.
Measured: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients muscle architecture
Assessment using muscle ultrasonography
Measured: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients quality of life
Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3)
Measured: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Evaluation of patient cachexia
Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)
Measured: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start16 Sep 2020
- Primary completion20 May 2021
- Study completion20 May 2021
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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Collaborators
- UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638712
- Sponsor's protocol ID
- 2020-006
- Other IDs
- 2020-A01266-33
- Acronym
- PROTECT-03
- Status last verified
- Feb 2023
- First submitted
- 2 Nov 2020
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCollection 2021.
PubMed 34595171Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.
PubMed 35373507Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.
PubMed 36094434
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04638712
- Acronym / sponsor ID
- PROTECT-03 / 2020-006
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Collaborators
- UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
- Study start
- 16 Sep 2020 (actual)
- Primary completion
- 20 May 2021 (actual)
- Study completion
- 20 May 2021 (actual)
- First posted
- 20 Nov 2020 (actual)
- 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.
This is an interventional, prospective and monocentric study. This study includes the evaluation before and after (neo)adjuvant therapy of :
- one group of patients receiving anthracyclines and taxanes
- a second group of patients receiving anthracyclines, taxanes and trastuzumab.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 without trastuzumab | Other | Other: Microbiopsy sample, Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level |
| Group 2 with trastuzumab | Other | Other: Microbiopsy sample, Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be ≥ 18 years old
- Patients with breast cancer stage I to III
- Patients who will receive (neo)adjuvant anthracyclines and weekly taxane, without trastuzumab
- Patients must have a social security coverage
- Patients able to speak, read and understand French
Key exclusion criteria (9 listed)
- History of cancer
- Previous chemotherapy
- Patients with known chronic pathology (musculoskeletal disorders, autoimmune, vascular or neuromuscular disease)
- Pacemaker implantation
- Contraindication to physical condition evaluation
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 |
|---|---|---|
| Microbiopsy samplebefore and after chemotherapy | Other | Group 1 without trastuzumab, Group 2 with trastuzumab |
| Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity levelbefore and after chemotherapy | Other | Group 1 without trastuzumab, Group 2 with trastuzumab |
Primary outcome
Change in vastus lateralis cross-sectional area
Time frame: Between Week 18 and 24 after chemotherapy
Measured from muscle microbiopsy sample
5 secondary outcomes
Alteration of patients body composition
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients strength
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients muscle architecture
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients quality of life
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Evaluation of patient cachexia
Time frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Results publication: PubMed 34595171Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCollection 2021.
- Results publication: PubMed 35373507Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.
- Results publication: PubMed 36094434Mallard J, Hucteau E, Bender L, Charlot A, Debrut L, Pflumio C, Trensz P, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Development of skeletal muscle atrophy and intermuscular adipose tissue in patients with early breast cancer treated with chemotherapy. Am J Physiol Cell Physiol. 2022 Oct 1;323(4):C1325-C1332. doi: 10.1152/ajpcell.00373.2022. Epub 2022 Sep 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microbiopsy sample and Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level in people with Breast Cancer, run by Institut de cancérologie Strasbourg Europe 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 12 inclusion and 9 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 9 Feb 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in vastus lateralis cross-sectional area (time frame: Between Week 18 and 24 after chemotherapy). 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 NCT04638712, 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 9 Feb 2023.