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

Breast Cancer Clinical Trial

— PROTECT-03  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638712
• Other study ID #: 2020-006
• Secondary ID: 2020-A01266-33
• Status: Completed
• Phase: N/A
• Start date: September 16, 2020
• Est. completion date: May 20, 2021

Study information

• Verified date: February 2023
• Source: Institut de cancérologie Strasbourg Europe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 20, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Microbiopsy sample
before and after chemotherapy
• Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
before and after chemotherapy

Locations

Country	Name	City	State
France	Institut de Cancerologie Strasbourg Europe	Strasbourg

Sponsors (2)

Lead Sponsor	Collaborator
Institut de cancérologie Strasbourg Europe	UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

Country where clinical trial is conducted

France, 

References & Publications (3)

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 chemothe — View Citation

Mallard J, Hucteau E, Charles AL, Bender L, Baeza C, Pelissie M, Trensz P, Pflumio C, Kalish-Weindling M, Geny B, Schott R, Favret F, Pivot X, Hureau TJ, Pagano AF. Chemotherapy impairs skeletal muscle mitochondrial homeostasis in early breast cancer pati — View Citation

Mallard J, Hucteau E, Hureau TJ, Pagano AF. Skeletal Muscle Deconditioning in Breast Cancer Patients Undergoing Chemotherapy: Current Knowledge and Insights From Other Cancers. Front Cell Dev Biol. 2021 Sep 14;9:719643. doi: 10.3389/fcell.2021.719643. eCo — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vastus lateralis cross-sectional area	Measured from muscle microbiopsy sample	Between Week 18 and 24 after chemotherapy
Secondary	Alteration of patients body composition	Assessment using bio-impedance analysis	Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Secondary	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)
Secondary	Alteration of patients muscle architecture	Assessment using muscle ultrasonography	Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Secondary	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)
Secondary	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)