Phase II Clinical Trial Aiming at Investigating the Effect of a PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Assistance Publique - Hôpitaux de Paris0 sites12 target enrollmentMay 2022

ConditionsMetastatic Breast Cancer in Germline-PALB2 Mutations Carriers

InterventionsNiraparib

DrugsNiraparib

Overview

Phase: Phase 2
Intervention: Niraparib
Conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers
Sponsor: Assistance Publique - Hôpitaux de Paris
Enrollment: 12
Primary Endpoint: Objective response rate
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2022

End Date

May 2030

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Assistance Publique - Hôpitaux de Paris

Responsible Party

Sponsor

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-
•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)

Arms & Interventions

Niraparib

PARP-inhibitor, Niraparib Dosage : starting 300 mg/day for patients with body weight ≥77kg and platelet counts ≥ 150 000/µl or 200 mg when body weight inferior to 77kg and/or platelet counts ≤ 150 000/µl and \> 100 000/µl Pharmaceutical form : 100 mg capsules Posology : single dose daily Route of administration : oral Administration procedures : oral, daily single dose Duration of treatment : 12 cycles of 28 days each

Intervention: Niraparib

Outcomes

Primary Outcomes

Objective response rate

Time Frame: 4 months

Complete or partial tumour response according to RECIST 1.1 criteria accounting for objective response rate in solid tumours at 4 cycles., based on the CT-Scan