Clinical trial NCT05232006: PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
Official title: Phase II Clinical Trial Aiming at Investigating the Effect of a PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-02-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Two-stage optimal Simon design
Primary purpose: TREATMENT

Brief summary: The study aims at exploring the potential benefit of a PARP-inhibitor, Niraparib, in metastatic breast cancer developing in germline-PALB2 mutations carriers. This study is designed as a multicentre one-arm two-stage phase 2 clinical trial


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)

Primary outcomes:
measure: Objective response rate
timeFrame: 4 months
Secondary outcomes:
measure: Progression-free survival
timeFrame: 12 months
measure: Overall survival
timeFrame: 12 months
measure: Tumoral response
timeFrame: 12 months
measure: Duration of response
timeFrame: 12 months
measure: Adverse event rate
timeFrame: 72 months
measure: Quality of Life variation
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: