Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
PROTECT-03
2 other identifiers
interventional
13
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Sep 2020
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 16, 2020
CompletedFirst Submitted
Initial submission to the registry
November 2, 2020
CompletedFirst Posted
Study publicly available on registry
November 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2021
CompletedFebruary 9, 2023
February 1, 2023
8 months
November 2, 2020
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Change in vastus lateralis cross-sectional area
Measured from muscle microbiopsy sample
Between Week 18 and 24 after chemotherapy
Secondary Outcomes (5)
Alteration of patients body composition
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients strength
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients muscle architecture
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients quality of life
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Evaluation of patient cachexia
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Study Arms (2)
Group 1 without trastuzumab
OTHERGroup 2 with trastuzumab
OTHERInterventions
before and after chemotherapy
before and after chemotherapy
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancerologie Strasbourg Europe
Strasbourg, 67033, France
Related Publications (3)
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.
PMID: 34595171RESULTMallard 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.
PMID: 35373507RESULTMallard 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.
PMID: 36094434RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2020
First Posted
November 20, 2020
Study Start
September 16, 2020
Primary Completion
May 20, 2021
Study Completion
May 20, 2021
Last Updated
February 9, 2023
Record last verified: 2023-02