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

Официальное название

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

Обзор

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

Вмешательства

• Препарат Niraparib
  Niraparib, once daily

Первичные конечные точки

• Objective response rate [Срок оценки: 4 months]

Вторичные конечные точки (6)

• Progression-free survival [Срок оценки: 12 months]
• Overall survival [Срок оценки: 12 months]
• Tumoral response [Срок оценки: 12 months]
• Duration of response [Срок оценки: 12 months]
• Adverse event rate [Срок оценки: 72 months]
• Quality of Life variation [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05232006 · P170929J

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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