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

NCT05232006 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: P170929J
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Metastatic Breast Cancer in Germline-PALB2 Mutations Carriers

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Progression-free survival

  12 months

• Overall survival

  12 months

• Tumoral response

  12 months

• Duration of response

  12 months

• Adverse event rate

  72 months

Study Arms (1)

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

Interventions

Niraparib DRUG

Niraparib, once daily

Niraparib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Interventions

niraparib

Central Study Contacts

Odile Cohen Haguenauer, MD PhD

CONTACT

+ 33 1 42 49 47 98; odile.cohen-haguenauer@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-stage optimal Simon design

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 9, 2022
• Study Start: May 1, 2022
• Primary Completion: September 1, 2024
• Study Completion (Estimated): May 1, 2030
• Last Updated: March 8, 2022

Record last verified: 2022-01