CERALASERTIB for Advanced triple-negative breast cancer

Inclusion criteria

• {"criterion_text":"- Metastatic TNBC patients, chemotherapy naïve therapy for metastatic treatment and whose tumor have relapsed from treatment with curative intent for early disease, which must include ICI and chemotherapy as part of radical locoregional therapy\n- Acceptable organ functions measured within 28 days prior to trial\n- Negative pregnancy test and willingness to use effective contraceptive methods from screening to 90 days from the last dose of durvalumab\n- Documented disease progression (e.g., with biopsy sample, pathology or imaging report) since the last treatment in early setting with curative intent (neo/adjuvant regimen)\n- ATRiBRAVE trial written informed consent\n- Age =18 years old\n- Ability to comply with the study protocol in the investigator’s judgment, including ability to swallow and retain oral medication\n- Availability of a formalin-fixed, paraffin-embedded block (FFPE) containing primary tumor tissue or at least 10-20 unstained tumor slides\n- Negative ER/PgR and HER2 status, confirmed in the most recent tumor sample (primary and/or metastatic)\n- Evaluable disease as defined by RECIST 1.1\n- ECOG performance status 0-1"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of ataxia telangiectasia\n- Any other clinical condition that may render the patient at high risk from treatment complications\n- Any previous treatment with ATR inhibitors, or DNA-damage repair inhibitors\n- An adequate washout period prior to the start of study for any anticancer therapy\n- Second primary cancer, except: non-melanoma skin cancer, or solid tumours curatively treated with no evidence of disease for =3 years\n- Active or prior documented autoimmune or inflammatory disorders\n- Patients with confirmed COVID-19 infection by PCR test who have not made a full recovery\n- Leptomeningeal disease or symptomatic untreated CNS metastatic disease or cord compression. Asymptomatic metastases are conditionally eligible\n- Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia and vitiligo\n- Any evidence of severe or uncontrolled organ or systemic disease"}

Primary endpoints

• {"endpoint_text":"- Progression free survival (PFS), defined as the number of days between the first study treatment administration to the date of first documented disease progression, relapse or death from any cause.","definition_or_measurement_approach":"Defined as the number of days between the first study treatment administration to the date of first documented disease progression, relapse or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Overall Response Rate (ORR) according to RECIST v 1.1 criteria","definition_or_measurement_approach":"Measured according to RECIST v1.1 criteria."}
• {"endpoint_text":"- Disease Control Rate (DCR) defined as the percentage of subjects whose disease shrinks or remains stable at 12 weeks. DCR is the sum of the complete response (CR), partial response (PR) and stable disease (SD) rates","definition_or_measurement_approach":"Percentage of subjects with CR+PR+SD at 12 weeks."}
• {"endpoint_text":"- Clinical Benefit Rate (CBR) defined as the proportion of patients with no disease progression at 24 weeks","definition_or_measurement_approach":"Proportion of patients without disease progression at 24 weeks."}
• {"endpoint_text":"- Duration of Response (DoR) defined as the time from the date of first documented confirmed response until date of documented progression per RECIST v1.1 or death due to any cause","definition_or_measurement_approach":"Time from first documented confirmed response to documented progression per RECIST v1.1 or death."}
• {"endpoint_text":"- Overall Survival (OS) defined as the number of days between the first study treatment administration and death","definition_or_measurement_approach":"Number of days between first study treatment administration and death from any cause."}
• {"endpoint_text":"- Occurrence of Adverse Events (AEs), including treatment-related AEs and AEs of special interest","definition_or_measurement_approach":"Recording and reporting of AEs including treatment-related and AEs of special interest per study safety monitoring procedures (NCI CTCAE grading referenced elsewhere)."}

Italy

Earliest CTIS Part Ii Submission Date

16-04-2024

Latest Decision Or Authorization Date

16-10-2025

Processing Time Days

548

Number Of Sites

7

Number Of Participants

37

Primary sponsor

Full Name

IFOM Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Pharma D&S","duties_or_roles":"sponsorDuties codes: 8","organisation_type":"Health care"}
• {"country":"Italy","full_name":"Istituto di Ricerche farmacologiche Mario Negri -IRCCS","duties_or_roles":"sponsorDuties codes: 10","organisation_type":"Educational Institution"}
• {"country":"Italy","full_name":"Euromed Pharma Services S.r.l.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Lb Research S.r.l.","duties_or_roles":"sponsorDuties codes: 1,12,6,7","organisation_type":"Pharmaceutical company"}