Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients (PROTECT-03)

February 7, 2023 updated by: Institut de cancérologie Strasbourg Europe

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 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

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in vastus lateralis cross-sectional area
Time Frame: Between Week 18 and 24 after chemotherapy
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
Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Assessment using bio-impedance analysis
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients strength
Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
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
Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Assessment using muscle ultrasonography
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Alteration of patients quality of life
Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
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
Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)
Questionnaire Functional Assessment of Anorexia/Cachexia Therapy (FAACT) (version 4)
Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy)

Collaborators and Investigators

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

Sponsor

Institut de cancérologie Strasbourg Europe

Collaborators

UR 3072 - Mitochondries, Stress oxydant, Protection musculaire

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)

September 16, 2020

Primary Completion (ACTUAL)

May 20, 2021

Study Completion (ACTUAL)

May 20, 2021

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (ACTUAL)

November 20, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-006
  • 2020-A01266-33 (OTHER: IDRCB)

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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