A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
Breast Cancer
Unknown Primary
18 - 130 Years, Male and Female
D926XC00001 (primary)
NCI-2023-00614
2022-002680-30
Summary
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with
ICT in participants with stage I to III TNBC with residual invasive disease in the breast
and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Objectives
The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab
when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I
to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes
at surgical resection following neoadjuvant systemic therapy.
The primary objective of the study is to demonstrate superiority of Dato-DXd in
combination with durvalumab relative to ICT by assessment of iDFS in participants with
stage I to III TNBC with residual invasive disease at surgical resection following
neoadjuvant therapy.
Eligibility
- Participant must be â?¥ 18 years at the time of screening.
- Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
- Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
- Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without platinum chemotherapy, with or without pembrolizumab.
- No evidence of locoregional or distant relapse.
- Surgical removal of all clinically evident disease in the breast and lymph nodes.
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
- All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis.
- No adjuvant systemic therapy.
- Radiotherapy (if indicated) delivered before the start of study intervention.
- If post-operative radiation therapy is given, an interval of no more than 6 weeks between the completion of radiation therapy and the date of randomisation (radiation therapy can be completed during screening period). If no post-operative radiation therapy is given, an interval of no more than 16 weeks between the date of breast surgery and the date of randomisation.
- Has LVEF â?¥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.
- Eligible for one of the therapy options listed as investigator's choice per investigator assessment.
- No known germline BRCA1 or BRCA2 pathogenic mutation.
- Adequate bone marrow reserve and organ function within 7 days before randomisation.
Treatment Sites in Georgia
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