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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT05135104
Eligibility Criteria:
Inclusion Criteria:
1. Adult women and men (≥ 18 years of age) with proven initial diagnosis of breast cancer with evidence of loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy.
2. Documentation of histologically or cytologically confirmed diagnosis of breast cancer with IHC of estrogen receptor (ER) expression \> 1% and/or progesterone receptor (PR) expression \>1 % breast cancer based on local laboratory results.
3. Scoring of 0 or 1+ for HER2 protein expression by a validated immunohistochemistry assay or +1/+2 with negative HER2 amplification FISH/ISH ratio lower than 1.8 or HER2 gene copy less than 4.0.
4. Eligible subjects must have undergone a treatment with Palbociclib for at least 3 months.
5. Measurable or evaluable disease as defined per modified Response Evaluation Criteria in Solid Tumours (mRECIST) V1.1 criterion (at least 2 entries).
6. Premenopausal or postmenopausal status.
6.1 Patients who are not postmenopausal must have undergone a treatment with LHRH agonist.
6.2 Postmenopausal status is defined as:
1. prior bilateral surgical oophorectomy, or
2. spontaneous cessation of regular menses for at least 12 consecutive months
3. in case of doubt serum estradiol \<20 umol/l and follicle stimulating hormone (FSH) levels \>15 IU/L.
Exclusion Criteria:
1. Subjects with advanced, symptomatic, visceral spread, such as patients with massive uncontrolled effusions (pleural, pericardial, peritoneal), pulmonary lymphangitis, and over 50% liver involvement).
2. Palbociclib treatment as part of a clinical trial or prescription prior to market approval (Nov 2016).
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05135104
Study Brief:
Protocol Section:
NCT05135104