Clinical trial · Interventional
Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
NCT04638712CI-TRIAL-00063803PROTECT-03completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microbiopsy sample | Other | — | UNRESOLVED |
| Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Group 1 without trastuzumab
- interventionNames
- Other: Microbiopsy sample
- Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
- type
- OTHER
- label
- Group 2 with trastuzumab
- interventionNames
- Other: Microbiopsy sample
- Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
Primary outcomes (1)
- measure
- Change in vastus lateralis cross-sectional area
- timeFrame
- Between Week 18 and 24 after chemotherapy
- description
- Measured from muscle microbiopsy sample
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: * 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
References
Publications (3)
- RESULTMallard 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 34595171
- RESULTMallard 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 35373507
- RESULTMallard 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 36094434