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

NCT ID: NCT06536556

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-02
• Study Completion Date: 2025-02-03

Brief Summary

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.

Detailed Description

Breast cancer patients are commonly treated with chemotherapy, which is known to induce severe side effects such as skeletal muscle deconditioning, characterized by skeletal muscle atrophy and major mitochondrial alterations. These maladaptations, observed in patients treated with epirubicin-cyclophosphamide (EC) followed by weekly paclitaxel (TAX), ultimately lead to reduction in exercise capacity and quality of life. However, little is known about the specific effect of each type of chemotherapy.

In our recent article (see Citations field in the References module), The investigators demonstrated that chemotherapy effects on skeletal muscle are drug-dependent. Using muscle biopsies before and 4 days after the first administration of EC or TAX, we demonstrated that unlike TAX, EC induced severe muscle atrophy and mitochondrial alterations. Of note, patients in the TAX group had already received EC during the preceding weeks (Figure 1). Therefore, these patients had already begun to have altered skeletal muscle homeostasis, which might have limited the influence of TAX compared with that of its administration in isolation (i.e., without other previous chemotherapy administrations). In addition, some patients had received, concomitantly with TAX, Trastuzumab (TRASTU) due to HER tumor mutation. Also, in triple negative breast cancers, the recommendations concerning neo(adjuvant) chemotherapy have recently changed and recommend starting treatment with the use of paclitaxel + carboplatin (TAX + CARBO).

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TAX Group

Woman with early breast cancer receiving a first cycle of TAX

First Assessment

Intervention Type: OTHER

pre-treatment assessment

Second Assessment

Intervention Type: OTHER

4 days post-treatment assessment

TAX+TRASTU Group

Woman with early breast cancer receiving a first cycle of TAX+TRASTU

First Assessment

Intervention Type: OTHER

pre-treatment assessment

Second Assessment

Intervention Type: OTHER

4 days post-treatment assessment

TAX+CARBO Group

oman with early breast cancer receiving a first cycle of TAX+CARBO

First Assessment

Intervention Type: OTHER

pre-treatment assessment

Second Assessment

Intervention Type: OTHER

4 days post-treatment assessment

Interventions

First Assessment

pre-treatment assessment

Intervention Type: OTHER

Second Assessment

4 days post-treatment assessment

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut de cancérologie Strasbourg europe

Strasbourg, , France

Countries

France

References

Mallard 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.

Reference Type: BACKGROUND

PMID: 36094434 (View on PubMed)

Other Identifiers

2023-029

Identifier Type: -

Identifier Source: org_study_id