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:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT01564056
Eligibility Criteria:
Inclusion Criteria:
* Women aged ≥ 70 yo,
* Histologically proven invasive breast cancer (regardless of the type),
* Complete surgery performed before enrolment: radical modified mastectomy or breast conservative surgery, with either a sentinel lymph node procedure or axillary lymph node dissection,
* Any N status (pN+ or pN0),
* No clinically or radiologically detectable metastases (M0),
* Oestrogen receptor (ER)-positive, as defined by a ≥ 10% tumor stained cells by immunohistochemistry (IHC),
* HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative),
* Normal haematological function: ANC ≥ 1,500/mm3; platelets count ≥ 100,000/mm3; haemoglobin \> 9 g/dl,
* Normal hepatic function: total bilirubin ≤ 1.25 ULN; ASAT and ALAT ≤ 1.5 ULN; alkaline phosphatases ≤ 3 ULN,
* Creatinine clearance (MDRD formula) ≥ 40 mL/min,
* PS (ECOG) ≤ 2,
* Patient able to comply with the protocol,
* Patients must have signed a written informed consent form prior to any study specific procedures, including the agreement for the use of archived tumoral material for genomic screening and data collection,
* Patients must be affiliated to a Social Health Insurance.
Exclusion Criteria:
* Any metastatic impairment, including homolateral sub-clavicular node involvement, regardless of its type,
* Any tumor ≥ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast cancer),
* ER-negative breast cancer (i.e. \<10% tumor stained cells by IHC),
* HER2 overexpression, defined as IHC score 3+ or score 2+ and FISH/SISH/CISH positive,
* Any chemotherapy, hormonal therapy or radiotherapy for breast cancer before surgery,
* PS (ECOG) ≥ 3,
* Any specific contra-indication to the study drugs (including but not limited to hypersensitivity to the study drugs or their components),
* Patient deprived of freedom or under tutelage,
* Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
70 Years
Study:
NCT01564056
Study Brief:
Protocol Section:
NCT01564056