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:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
NCT ID:
NCT05232006
Eligibility Criteria:
Inclusion Criteria:
* Adult patients over 18 years
* PALB2 germline heterozygous mutation carrier, wild type BRCA1\&2 (breast cancer 1\&2) affected with metastatic breast cancer in first metastatic treatment line or beyond
* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
* Triple Negative breast cancer; Patients affected with triple negative cancers should have received anthracyclines and taxanes in neo/adjuvant therapy.
* Or patients with Hormonal receptor positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) breast cancer, with treatment failure after a second line of therapy; Estrogen Receptor/ProgesteroneReceptor breast cancer positive patients must have received and progressed on currently recommended therapies in this indication (endocrine therapy, CDK4/6 inhibitors (adjuvant or metastatic)), or have a disease form that the treating physician believes to be inappropriate for recommended therapies in this indication.
* Prior therapy with an anthracycline and a taxane in an adjuvant setting.
* Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting, at least 12 months elapsed from last dose to study entry.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Adequate bone marrow, kidney and liver function.
* Patients without visceral crisis
Exclusion Criteria:
* Patients with HER2 positive disease.
* Untreated and/or uncontrolled brain metastases.
* Patients in visceral crisis requiring chemotherapy
* Cytopenia, defined with the following thresholds: (i) Neutrophil count \< 1500/mm3; Platelet count\< 100 000/mm3; Hemoglobin \<9g/dL
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS) or stage I grade 1 endometrial cancer allowed.
* Known HIV (Human Immunodeficiency Virus) infection.
* Pregnant or breast-feeding women.
* Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05232006
Study Brief:
Protocol Section:
NCT05232006