Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-25 @ 3:04 AM
NCT ID:
NCT04354233
Eligibility Criteria:
Inclusion Criteria:
* 1\) female,
* 2\) ≥ 18 years old,
* 3\) histologically confirmed metastatic breast cancer, with at least one positive hormone receptor (HR+) and HER2-,
* 4\) first-line chemotherapy planned (or until 1 month after the chemotherapy has started) with intravenous (Paclitaxel or Doxorubicin or Cyclophosphamide or Carboplatin) or per os (Capecitabine or Vinorelbine) administration - NB : a patient who has previously received one or more lines of hormone therapy and who must start a 1st line of chemotherapy is eligible,
* 5\) Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2,
* 6\) life expectancy ≥ 3 months,
* 7\) willing to be involved throughout the study,
* 8\) ability to practice a adapted physical activity (APA) certified by a medical certificate issued by the referring oncologist or the clinical investigator,
* 9\) using a compatible smartphone or Tablet PC to download the application ABLE02 and Withings Health Mate (from iOS 10 and android 6.0 and more recent),
* 10\) Internet access,
* 11\) valid health insurance affiliation,
* 12\) able to read, write and understand French.
Exclusion Criteria:
* 1\) presence of unstable bone metastases or unconsolidated pathological fractures,
* 2\) presence of central nervous system involvement with neurological deficits that prevent from walking,
* 3\) presence of a history or co-existence of other primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years),
* 4\) severe undernutrition (HAS) (i.e. for women ≤ 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month and for women over 70 years old: a weight loss of ≥ 15% in 6 months or ≥10% in 1 month, and body mass index \<18 kg/m²),
* 5\) presenting a PA contraindication (e.g., uncontrolled hypertension, uncontrolled heart disease),
* 6\) concurrent participation in another PA study,
* 7\) unable to be followed for medical, social, family, geographical or psychological reasons throughout the study,
* 8\) deprived of liberty by judicial or administrative decision,
* 9\) pregnant.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT04354233
Study Brief:
Protocol Section:
NCT04354233