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

NCT ID: NCT04638712

Last Updated: 2023-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2021-05-20

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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1 without trastuzumab

Group Type OTHER

Microbiopsy sample

Intervention Type OTHER

before and after chemotherapy

Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level

Intervention Type OTHER

before and after chemotherapy

Group 2 with trastuzumab

Group Type OTHER

Microbiopsy sample

Intervention Type OTHER

before and after chemotherapy

Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level

Intervention Type OTHER

before and after chemotherapy

Interventions

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Microbiopsy sample

before and after chemotherapy

Intervention Type OTHER

Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level

before and after chemotherapy

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

UNKNOWN

Sponsor Role collaborator

Institut de cancérologie Strasbourg Europe

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancerologie Strasbourg Europe

Strasbourg, , France

Site Status

Countries

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France

References

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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. eCollection 2021.

Reference Type RESULT
PMID: 34595171 (View on PubMed)

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 patients. J Cachexia Sarcopenia Muscle. 2022 Jun;13(3):1896-1907. doi: 10.1002/jcsm.12991. Epub 2022 Apr 4.

Reference Type RESULT
PMID: 35373507 (View on PubMed)

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 RESULT
PMID: 36094434 (View on PubMed)

Other Identifiers

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2020-A01266-33

Identifier Type: OTHER

Identifier Source: secondary_id

2020-006

Identifier Type: -

Identifier Source: org_study_id

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