Breast cancer
Conditions
Interventions
Talazoparib
Sponsors
Erasmus Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: • Age =18 years • WHO performance status 0-2 • Locally advanced breast cancer without options for treatment with curative intent or metastatic breast cancer • Objective progressive disease (PD) according to RECIST within 4 months prior to study entry • The breast cancer must be high grade (Bloom & Richardson grade 3) ER positive (>10%) and HER2 negative primary breast cancer or triple negative (ER100 x 10e9/L • Hepatic function as defined by total serum bilirubin = 1. 5 x ULN (except elevated bilirubin due to Gilbert’s disease or a similar syndrome involving slow conjugation of bilirubin), ASAT and ALAT < 3 x ULN or <5 x ULN in case of liver metastasis • Adequate renal function as defined by either serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min (by Cockcroft-Gault formula) • Negative pregnancy test (urine/serum) for female patients with childbearing potential • Written informed consent
Exclusion criteria
Exclusion criteria: • Any psychological condition potentially hampering compliance with the study protocol • Any treatment with investigational antitumor drugs within 28 days prior to receiving the first dose of investigational treatment; or within 21 days for standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy • Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1 or 2 x 8 Gy for pain palliation, then seven days interval after the last radiation should be maintained • Known persistent (>4 weeks) = Grade 2 toxicity from prior cancer therapy (except for alopecia grade 2) • Symptomatic brain or leptomeningeal metastases. Patients completely free of symptoms and without corticosteroids for at least four weeks after adequate treatment by resection and/or irradiation could be eligible (consult PI). • Women who have a positive pregnancy test (urine/serum) and/or who are breastfeeding; • Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence) • Concomitant use of P-gp inhibitors or inducers or BCRP inhibitors (see Appendix A) • Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) • Uncontrolled infectious disease (such as Human Immunodeficiency Virus HIV-1 or HIV-2 infection) or known active hepatitis B or C • Recent myocardial infarction (< six months) or unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To test if the RECAP test has the potential of selecting patients who are sensitive to treatment with the PARP inhibitor talazoparib. | — |
Secondary
| Measure | Time frame |
|---|---|
| - To determine overall response rate and overall survival among patients with HRD tumors treated with talazoparib. | — |
Contacts
Public ContactDr. A. Jager
Erasmus Medical Center
Outcome results
None listed