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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Microbiopsy sample; Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level

• Registration Number: NCT04638712
• Lead Sponsor: Institut de cancérologie Strasbourg Europe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-11-02
• Study First Submitted QC: 2020-11-16
• Study First Posted: 2020-11-20
• Primary Completion: 2021-05-20
• Study Completion: 2021-05-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 without trastuzumab	Microbiopsy sample	-
Group 2 with trastuzumab	Microbiopsy sample	-
Group 2 with trastuzumab	Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level	-
Group 1 without trastuzumab	Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level	-

Primary Outcome Measures

Name	Time	Method
Change in vastus lateralis cross-sectional area	Between Week 18 and 24 after chemotherapy	Measured from muscle microbiopsy sample

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut de Cancerologie Strasbourg Europe; 🇫🇷 Strasbourg, France