Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Microbiopsy sample
* Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group 1 without trastuzumab<br> | Other: Microbiopsy sample<br>* before and after chemotherapy<br>Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level<br>* before and after chemotherapy<br>|
| Other: Group 2 with trastuzumab<br> | Other: Microbiopsy sample<br>* before and after chemotherapy<br>Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level<br>* before and after chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vastus lateralis cross-sectional area | Measured from muscle microbiopsy sample | Between Week 18 and 24 after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alteration of patients body composition | Assessment using bio-impedance analysis | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | 
| Alteration of patients strength | Assessment of maximal isometric muscle strength for knee extensors measured with force sensors. | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | 
| Alteration of patients muscle architecture | Assessment using muscle ultrasonography | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | 
| Alteration of patients quality of life | Self-assessment questionnaire Functional Assessment of Cancer Therapy - General (FACT-G) (version 3) | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) | 
| Evaluation of patient cachexia | Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4) | Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) |