Patients with HER2 positive disease.
Conditions
Interventions
Trade Name: Zejula 100 mg gélules
Product Code: GSK 3985771, MK-4827
Pharmaceutical Form: Capsule
Sponsors
Assistance Publique – Hôpitaux de Paris (AP-HP)
Eligibility
Sex/Gender
All
Inclusion 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 Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with HER2 positive disease. • Untreated and/or uncontrolled brain metastases. • Cytopenia, defined with the following thresholds: (i) PN 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy in term of tumour response at four cycles as potential efficacy of a PARP-inhibitor in patients with metastatic breast cancers, carrying germline PALB2 mutations.;Secondary Objective: •To evaluate progression-free survival (PFS) and overall survival •To evaluate overall clinical benefit •To evaluate duration of improvement: based both on clinical assessment and imaging •To evaluate tolerance and toxicity, haematology parameters in particular •To evaluate Quality of Life (QOL) at baseline and every 3 cycles or at the time of study termination ;Primary end point(s): •Complete or partial tumour response according to RECIST 1.1 criteria accounting for objective response rate in solid tumours at 4. This will be established according to data recorded on the CT-Scan performed at the end of 4 cycles time point ± 10 days.;Timepoint(s) of evaluation of this end point: In the event of sole skin metastasis without other organ or bone metastasis, clinical examination of the skin tumours will be performed and pictures taken at regular interval for tumour response assessment (Baseline, 2, 4, 6, 9, 12 cycles). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time from inclusion to progression or death (all-cause) whichever occurs first, up to 12 months • Time from inclusion to death (all-cause) whichever occurs first, up to 12 months • Partial Response (PR) or Complete Response (CR) or Stable Disease (SD), as per to RECIST 1.1 criteria for tumoral response, based on CT-Scan at 2, 4, 6, 9, 12 cycles In the event of sole skin metastasis without other organ or bone metastasis, clinical examination of the skin tumours will be performed and pictures taken at regular interval for tumour response assessment (Baseline, 2, 4, 6, 9, 12 cycles). ;Timepoint(s) of evaluation of this end point: • Time to treatment failure (TTF) up to M12, defined as time between inclusion and treatment discontinuation (any reason: death, disease progression, toxicity) or last visit (M12). | — |
Countries
France
Contacts
Public ContactSEYMOUR-INAMO
APHP
Outcome results
None listed