Clinical trial · Observational
Effects of a Single Chemotherapy Administration on Skeletal Muscle of Breast Cancer Patients: Comparison of Paclitaxel vs Paclitaxel + Trastuzumab vs Paclitaxel + Carboplatine: the PROTECT-06 Bis Study
NCT06536556CI-TRIAL-00100092PROTECT-06-bisterminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment sufficiant in term of statistical power
Summary
Brief summary (as posted)
This study aims to investigate the acute effects (i.e. 4 days) of paclitaxel or paclitaxel vs trastuzumab or paclitaxel and carboplatine on skeletal muscle of breast cancer patients. Muscle biopsies will be performed, as well as measurements of body composition strength, muscle architecture and quality of life.
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 |
|---|---|---|---|
| First Assessment | Other | — | UNRESOLVED |
| Second Assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- TAX Group
- description
- Woman with early breast cancer receiving a first cycle of TAX
- interventionNames
- Other: First Assessment
- Other: Second Assessment
- label
- TAX+TRASTU Group
- description
- Woman with early breast cancer receiving a first cycle of TAX+TRASTU
- interventionNames
- Other: First Assessment
- Other: Second Assessment
- label
- TAX+CARBO Group
- description
- oman with early breast cancer receiving a first cycle of TAX+CARBO
- interventionNames
- Other: First Assessment
- Other: Second Assessment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: TAX group : * Female ≥ 18 years * Stage I to III breast cancer * Patient who has not yet started treatment with TAX * Enrolled in a social security scheme * Able to speak, read and understand French TAX+TRASTU group : * Female ≥ 18 years of age * Stage I to III breast cancer * Patient who has not yet started treatment with TAX+TRASTU (Tolaney regimen) * Enrolled in a social security scheme * Able to speak, read and understand French Exclusion Criteria: * Prior exposure to chemotherapy * Musculoskeletal disorders, autoimmune, vascular or neuromuscular disease * Implantation of a pacemaker * Contraindications to fitness evaluation * Contraindication to local anesthesia for microbiopsy * Minor or protected adult * Pregnant women
References
Publications (1)
- BACKGROUNDMallard 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