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Not yet recruiting NCT05232006

PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers

Phase II Interventional Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Niraparib.
Who it may be relevant to
Registry conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug Niraparib
    Niraparib, once daily

Primary outcome measures

  • Objective response rate [Time frame: 4 months]
Secondary outcome measures (6)
  • Progression-free survival [Time frame: 12 months]
  • Overall survival [Time frame: 12 months]
  • Tumoral response [Time frame: 12 months]
  • Duration of response [Time frame: 12 months]
  • Adverse event rate [Time frame: 72 months]
  • Quality of Life variation [Time frame: 12 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05232006 · P170929J

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗