PARP-inhibitor on Advanced Metastatic Breast Cancer in Ge... | NCT05232006

NCT05232006

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Niraparib	Experimental	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	Drug: Niraparib

Name	Type	Description	Arm Group Labels	Other Names
Niraparib	Drug	Niraparib, once daily	Niraparib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate	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	4 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival	Time from inclusion to progression or death (all-cause) or last follow-up whichever occurs first	12 months
Overall survival	Time from inclusion to death (all-cause) or last follow-up whichever occurs first

Eligibility Module

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)