RESTORING SENSITIVITY TO IMMUNOTHERAPY IN ADVANCED TRIPLE NEGATIVE BREAST CANCER EXPLOITING CERALASERTIB PRIMING FOLLOWED BY COMBINED DURVALUMAB/NAB-PACLITAXEL: THE ATRiBRAVE TRIA

Phase 1

• Conditions: ADVANCED TRIPLE NEGATIVE BREAST CANCER; MedDRA version: 26.0Level: LLTClassification code: 10006216Term: Breast carcinoma stage IV Class: 10029104; MedDRA version: 26.0Level: LLTClassification code: 10006215Term: Breast carcinoma stage III Class: 10029104; MedDRA version: 20.1Level: LLTClassification code: 10006212Term: Breast carcinoma recurrent Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-513721-23-00
• Lead Sponsor: IFOM Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-18
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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, Acceptable organ functions measured within 28 days prior to trial, Negative pregnancy test and willingness to use effective contraceptive methods from screening to 90 days from the last dose of durvalumab, 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), ATRiBRAVE trial written informed consent, Age =18 years old, Ability to comply with the study protocol in the investigator’s judgment, including ability to swallow and retain oral medication, Availability of a formalin-fixed, paraffin-embedded block (FFPE) containing primary tumor tissue or at least 10-20 unstained tumor slides, Negative ER/PgR and HER2 status, confirmed in the most recent tumor sample (primary and/or metastatic), Evaluable disease as defined by RECIST 1.1, ECOG performance status 0-1

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified