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Restoring Sensitivity To Immunotherapy In Advanced Triple Negative Breast Cancer Exploiting Ceralasertib Priming Followed By Combined Durvalumab/Nab-Paclitaxel

ConditionTriple Negative Breast Cancer Metastatic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIFOM ETS - The AIRC Institute of Molecular Oncology

About this trial

This study will evaluate the efficacy and safety of ceralasertib followed by durvalumab plus nab-paclitaxel in 37 patients with TNBC, whose tumor relapsed following treatment with curative intent for early disease, which must have included immunotherapy and chemotherapy as part of the radical locoregional therapy (either adjuvant, neoadjuvant or both).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ATRiBRAVE trial written informed consent, prior to any study specific procedures

Age ≥18 years old

Ability to comply with the study protocol in the investigator's judgment.

Ability to swallow and retain oral medication

Disqualifiers

Diagnosis of ataxia telangiectasia.

Any previous treatment with ATR inhibitors, DNA-damage repair inhibitors.

Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.

All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Ceralasertib

    Drug

    240mg orally BD (dose level 0) on days -6 to 0 prior to day 1 cycle 1 and then on days 22 to 28 of cycle 1 and every subsequent cycle

  • Durvalumab

    Drug

    1500 mg i.v. day 1 (q28)

  • Nab-paclitaxel

    Drug

    100mg/m2 i.v. day 1,8,15 (q28)

Treatment groups

37 Participants
are divided into 1 treatment group
Group A: TNBC patients treated with ceralasertib, durvalumab e nab-paclitaxelExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Progression free survival (PFS)

ATRiBRAVE will evaluate the 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).

Time frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months

Secondary outcomes

1

Overall Response Rate (ORR)

Overall Response Rate (ORR) according to RECIST v 1.1 criteria

Time frame
up to 12 months
2

Disease Control Rate (DCR)

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 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;

Time frame
3 months
3

Clinical Benefit Rate (CBR)

CBR defined as the proportion of patients with no disease progression at 24 weeks

Time frame
6 months
4

Duration of Response (DoR)

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

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

IFOM ETS - The AIRC Institute of Molecular Oncology

Lead sponsor

AstraZeneca

Collaborator

Source ClinicalTrials.gov
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