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 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
NCT ID:
NCT02102568
Eligibility Criteria:
Inclusion Criteria:
* Patient aged over 18 and under 45
* Patient without amenorrhea at diagnosis
* Performance status less than 2 (according to WHO criteria )
* Patient diagnosed with histologically proven non-metastatic breast cancer
* Clinical Stages I, IIA, IIB and IIIA
* Positive Hormone Receptors (defined by a rate of 10% of labeled cells and immunohistochemistry (IHC) ) or negative
* Positive or negative HER2 status ( defined a score of 0 or 1 + by IHC , or a 2 + score by IHC and FISH / ISHS / CISH negative)
* Patients to be treated with neoadjuvant or adjuvant chemotherapy
* Satisfying hematological, renal and hepatic functions : PNN\> 2,109 / L, platelets \> 100 . 109 / L, Hb\> 10 g / dl , normal bilirubin, AST and ALT \<2.5 upper normal value ( VNS) , alkaline phosphatase \<2.5 VSN , creatinine clearance \> 60 ml / min
* Obtaining informed consent in writing, signed and dated
* Affiliation to Social Security system (or being the beneficiary of such a plan) under the terms of the Act of August 9, 2004
Exclusion Criteria:
* Male patient
* Metastatic cancer
* Any T4 tumor (skin invasion, deep grip, inflammatory breast cancer)
* Patient who underwent surgical castration of ovariectomy or hysterectomy or tubal ligation
* Patients with endometriosis
* Pregnant or breastfeeding patients
* Patients with no effective contraception
* Patients who have had hormone therapy or chemotherapy
* Patient who have already taken Gn-RH or LH-RH analogues (chemical castration)
* Patient whose mother was in menopause early without treatment
* Presence of comorbidities related to fertility or medical history related to ovarian failure or sterility
* Significant neurological or psychiatric abnormalities
* Inability of the patient to complete the questionnaires (the language barrier)
* Patients deprived of liberty by court or administrative decision
* Patient with another pathology deemed incompatible with the inclusion of the patient in the protocol
* Participation in another clinical trial involving the chemical or surgical castration of the patient
* Patients geographically unstable in the 6 months following inclusion or residing away from the treatment center and thereby making it difficult to monitor
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02102568
Study Brief:
Protocol Section:
NCT02102568