PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers (PALB2-PARPi-01)

Assistance Publique - Hôpitaux de Paris

Status and phase: Not yet enrolling; Phase 2

Conditions: Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

Treatments: Drug: Niraparib

Study type: Interventional

Funder types: Other

Identifiers

NCT05232006

P170929J

Details and patient eligibility

About

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

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Niraparib

Experimental group

Description:

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

Treatment:

Drug: Niraparib