NCT05232006Not yet recruitingPhase 2
PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
Phase II Clinical Trial Aiming at Investigating the Effect of a PARP-inhibitor on Advanced Metastatic Breast Cancer in Germline PALB2 Mutations Carriers
Source: ClinicalTrials.gov · Last updated 8 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 28 Jan 2022
- Start date
- May 2022
- Primary completion date
- Sept 2024
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05232006
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 12
- From May 2022 to the primary completion date, Sept 2024
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients in visceral crisis requiring chemotherapy
Other illness
- Patients with HER2 positive disease.
- Known HIV (Human Immunodeficiency Virus) infection.
Lab values
- Cytopenia, defined with the following thresholds: (i) Neutrophil count \< 1500/mm3; Platelet count\< 100 000/mm3; Hemoglobin \<9g/dL
Age
- 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.
Other
- Untreated and/or uncontrolled brain metastases.
- Pregnant or breast-feeding women.
- Lack of affiliation to a social security benefit plan (as a beneficiary or assignee)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.