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NCT Number: NCT05232006

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Niraparib

Drug

Niraparib, once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. Progression-free survival

    Time frame: 12 months

    Time from inclusion to progression or death (all-cause) or last follow-up whichever occurs first

  2. Overall survival

    Time frame: 12 months

    Time from inclusion to death (all-cause) or last follow-up whichever occurs first

  3. Tumoral response

    Time frame: 12 months

    Partial Response or Complete Response or Stable Disease, as per to RECIST 1.1 criteria for tumoral response, based on CT-Scan

  4. Duration of response

    Time frame: 12 months

    Time to treatment failure, defined as time between inclusion and treatment discontinuation (any reason: death, disease progression, toxicity) or last follow-up

  5. Adverse event rate

    Time frame: 72 months

    Adverse events (clinical and biological) between inclusion and 72 months

  6. Quality of Life variation

    Time frame: 12 months

    European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life C30 Questionnaire, evaluated every 3 months, from inclusion to 12 month

Study contacts

Contact information is provided by the study sponsor or research team.

Odile Cohen Haguenauer, MD PhD

CONTACT

[email protected]

+ 33 1 42 49 47 98

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PALB2-PARPi-01

Important dates

Study start
2022
Primary completion
2024
Study completion
2030
First posted
Feb 9, 2022
Registry last updated
Mar 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.