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RESTORING SENSITIVITY TO IMMUNOTHERAPY IN ADVANCED TRIPLE NEGATIVE BREAST CANCER EXPLOITING CERALASERTIB PRIMING FOLLOWED BY COMBINED DURVALUMAB/NAB-PACLITAXEL: THE ATRiBRAVE TRIAL
EU CTIS ID: 2024-513721-23-00
What this study is testing
Evaluation of efficacy of ceralasertib followed by durvalumab plus Nab-paclitaxel in patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included ICIs and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.