A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patient… (NCT05629585) | Clinical Trial Compass
Active — Not RecruitingPhase 3
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)
United States1,174 participantsStarted 2022-11-28
Plain-language 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.
Who can participate
Age range18 Years – 130 Years
SexALL
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Inclusion criteria
✓. Participant must be ≥ 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.
Exclusion criteria
✕. Stage IV (metastatic) TNBC.
✕. History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
✕. Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea chronic diverticulitis or previous complicated diverticulitis.
What they're measuring
1
Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT
Timeframe: From randomisation to date of the event, up to 57 months from first subject in
✕. History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease (including ductal carcinoma in situ) that has undergone potentially curative therapy, or other solid malignancy treated with curative intent with no known active disease within 5 years before randomisation and of low potential risk for recurrence.
✕. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
✕. Active or prior documented autoimmune or inflammatory disorders.
✕. Clinically significant corneal disease.
✕. Active or uncontrolled hepatitis B or C virus infection.