EUCTR2019-003702-27-FR
Active, not recruiting
Phase 1
Phase II clinical trial aiming at investigating the effect of a PARP-inhibitor on advanced metastatic breast cancer in germline PALB2 mutations carriers - PALB2-PARPi-01
Assistance Publique – Hôpitaux de Paris (AP-HP)0 sites12 target enrollmentJanuary 19, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with HER2 positive disease.
- Sponsor
- Assistance Publique – Hôpitaux de Paris (AP-HP)
- Enrollment
- 12
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult patients over 18 years
- •PALB2 germline heterozygous mutation carrier, wild type BRCA1\&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
- •RH\+/HER2\- breast cancer; ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have a disease form that the treating physician believes to be inappropriate for endocrine therapy.
- •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.
- •ECOG performance status 0\-2\.
- •Adequate bone marrow, kidney and liver function.
- •Are the trial subjects under 18? no
Exclusion Criteria
- •Patients with HER2 positive disease.
- •Untreated and/or uncontrolled brain metastases.
- •Cytopenia, defined with the following thresholds: (i) PN \< 1500; Platelet count\< 100 000; Hb \<9g
- •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, 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)
Outcomes
Primary Outcomes
Not specified
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