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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)

I

Institut de cancérologie Strasbourg Europe

Status

Completed

Conditions

Breast Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04638712
2020-A01266-33 (Other Identifier)
2020-006

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

13 participants in 2 patient groups

Group 1 without trastuzumab
Other group
Treatment:
Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
Other: Microbiopsy sample
Group 2 with trastuzumab
Other group
Treatment:
Other: Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level
Other: Microbiopsy sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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