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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638712
Recruitment Status : Completed
First Posted : November 20, 2020
Last Update Posted : June 8, 2021
Sponsor:
Collaborator:
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
Information provided by (Responsible Party):
Institut de cancérologie Strasbourg Europe

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Microbiopsy sample Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of (Neo)Adjuvant Therapy Associating Anthracyclines and Taxanes With or Without Trastuzumab on Skeletal Muscle in Breast Cancer Patients
Actual Study Start Date : September 16, 2020
Actual Primary Completion Date : May 20, 2021
Actual Study Completion Date : May 20, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab

Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in vastus lateralis cross-sectional area [ Time Frame: Between Week 18 and 24 after chemotherapy ]
    Measured from muscle microbiopsy sample


Secondary Outcome Measures :
  1. Alteration of patients body composition [ Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) ]
    Assessment using bio-impedance analysis

  2. 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.

  3. Alteration of patients muscle architecture [ Time Frame: Baseline (=before chemotherapy) and Between Week 18 and 24 (=after chemotherapy) ]
    Assessment using muscle ultrasonography

  4. 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)

  5. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638712


Locations
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France
Institut de Cancerologie Strasbourg Europe
Strasbourg, France, 67033
Sponsors and Collaborators
Institut de cancérologie Strasbourg Europe
UR 3072 - Mitochondries, Stress oxydant, Protection musculaire
More Information
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Responsible Party: Institut de cancérologie Strasbourg Europe
ClinicalTrials.gov Identifier: NCT04638712    
Other Study ID Numbers: 2020-006
2020-A01266-33 ( Other Identifier: IDRCB )
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: June 8, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases