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 (PROTECT-06-bis)

December 30, 2025 updated by: Institut de cancérologie Strasbourg Europe
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67033
        • Institut de cancérologie Strasbourg Europe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with early-stage breast cancer receiving chemotherapy. It is planned to include a first group of 10 patients receiving their first administration of TAX and a second group of 10 patients receiving their first administration of TAX+TRASTU. A first session of assessments will take place before the first TAX or TAX+TRASTU session, and a second session 4 days (D4) after the session.

It is planned to include the same number of patients per group, i.e. 10 patients per group, for a total of 20 patients in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TAX Group
Woman with early breast cancer receiving a first cycle of TAX
Other: First Assessment
pre-treatment assessment
Other: Second Assessment
4 days post-treatment assessment
TAX+TRASTU Group
Woman with early breast cancer receiving a first cycle of TAX+TRASTU
Other: First Assessment
pre-treatment assessment
Other: Second Assessment
4 days post-treatment assessment
TAX+CARBO Group
oman with early breast cancer receiving a first cycle of TAX+CARBO
Other: First Assessment
pre-treatment assessment
Other: Second Assessment
4 days post-treatment assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the effects of a chemotherapy session on mitochondrial function of skeletal muscle in breast cancer patients by comparing the first session of TAX to the first session of TAX + TRASTU or +CARBO.
Time Frame: Change at 4 days post-treatment compare to baseline
difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.
Change at 4 days post-treatment compare to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the effect of the first TAX to the first TAX+TRASTU or +CARBO on muscle fiber cross-sectional area;cellular mechanisms of inflammation,fat infiltration and protein turnover;body composition;strength;muscle architecture and quality of life
Time Frame: Change at 4 days post-treatment compare to baseline
difference of a score combining the mitochondrial respiratory capacity with production of hydrogen peroxide, difference in protein levels (western blots) and mRNA (RT-qPCR) expression.
Change at 4 days post-treatment compare to baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut de cancérologie Strasbourg Europe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

February 3, 2025

Study Completion (Actual)

February 3, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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