Phase II clinical trial aiming at investigating the effect of a PARP-inhibitor on advanced metastatic breast cancer in germline PALB2 mutations carriers - PALB2-PARPi-01

Assistance Publique – Hôpitaux de Paris (AP-HP)0 个研究点目标入组 12 人开始时间: 2021年1月19日最近更新: 2024年5月21日

适应症

试验速览

暂无简介。

•Adult patients over 18 years
•PALB2 germline heterozygous mutation carrier, wild type BRCA1&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
•RH+/HER2- breast cancer; ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have a disease form that the treating physician believes to be inappropriate for endocrine therapy.
•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.
•ECOG performance status 0-2.
•Adequate bone marrow, kidney and liver function.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 12
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients with HER2 positive disease.
•Untreated and/or uncontrolled brain metastases.
•Cytopenia, defined with the following thresholds: (i) PN < 1500; Platelet count< 100 000; Hb <9g
•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, 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)

发起方

Assistance Publique – Hôpitaux de Paris (AP-HP)