{"entity":{"id":"nct03742102","kind":"trial","name":"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer","aka":["BEGONIA"],"tldr":"A phase 1/2 trial of Durvalumab, Capivasertib, Oleclumab, Trastuzumab deruxtecan and Datopotamab deruxtecan in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer is a phase 1/2 interventional study registered as NCT03742102 by AstraZeneca, with 243 participants enrolled, started 2018-12-21 and due to reach its primary completion in 2024-11-29. Interventions recorded: Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Trastuzumab deruxtecan and Datopotamab deruxtecan. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03742102","url":"https://clinicaltrials.gov/study/NCT03742102"},{"label":"BEGONIA arms 7 and 8 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2026.05.693"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","capivasertib","oleclumab","trastuzumab-deruxtecan","datopotamab-deruxtecan"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct03742102-ann-oncol-2026"],"journals":[],"dependsOn":[],"notes":["BEGONIA arms 7 and 8 (Annals of Oncology 2026): first-line datopotamab deruxtecan 6 mg/kg with durvalumab 1,120 mg every 3 weeks in 62 patients regardless of PD-L1 (arm 7) and 33 with PD-L1-high tumours (arm 8); confirmed response 79.0 and 81.8 percent, arm 7 median duration of response 17.6 months and progression-free survival 14.0 months with overall survival not reached at 35 months of follow-up. This is the phase 2 basis of TROPION-Breast05. UK sites: Cambridge, London, Manchester, Oxford."],"nct":"NCT03742102","phase":"1/2","setting":"A Phase IB/II, 2-stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer","sponsor":"AstraZeneca","started":"2018-12-21","startedType":"actual","yearReported":2026,"enrolled":243,"enrolledBasis":"registry","outcomes":[{"endpoint":"Dose Limiting Toxicity (DLT) Events","primary":true,"unit":"participants","arms":[{"name":"Arm 2","n":6,"value":0,"note":"Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 5","n":6,"value":0},{"name":"Arm 6","n":6,"value":0},{"name":"Arm 7","n":6,"value":0}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"},{"endpoint":"Overall Survival (Duration)","unit":"months","arms":[{"name":"Arm 1","n":23,"value":30,"note":"95% CI 13.0 to NA; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 2","n":31,"value":32.6,"note":"95% CI 12.9 to 40.0"},{"name":"Arm 5","n":33,"value":24.8,"note":"95% CI 18.6 to 31.9"},{"name":"Arm 6","n":58,"value":30.3,"note":"95% CI 18.8 to NA"},{"name":"Arm 7","n":62,"note":"NA - Not calculable due to insufficient number of events for upper limit of confidence interval"},{"name":"Arm 8","n":33,"note":"NA - Not calculable due to insufficient number of events for upper limit of confidence interval"}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"},{"endpoint":"Progression-free Survival (PFS)","unit":"months","arms":[{"name":"Arm 1","n":23,"value":7.3,"note":"95% CI 5.4 to 11.3; Figures from the ClinicalTrials.gov results section (first posted 2026-02-02), not from a publication"},{"name":"Arm 2","n":31,"value":6.4,"note":"95% CI 5.4 to 10.3"},{"name":"Arm 5","n":33,"value":8.3,"note":"95% CI 4.8 to 9.3"},{"name":"Arm 6","n":58,"value":12.6,"note":"95% CI 8.4 to 16.3"},{"name":"Arm 7","n":62,"value":14,"note":"95% CI 11.0 to 21.1"},{"name":"Arm 8","n":33,"value":11.2,"note":"95% CI 6.9 to 13.8"}],"source":"https://clinicaltrials.gov/study/NCT03742102?tab=results"}]},"route":"/trials/nct03742102/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"capivasertib","kind":"drug","name":"Capivasertib","route":"/drugs/capivasertib/"},{"id":"datopotamab-deruxtecan","kind":"drug","name":"Datopotamab deruxtecan","route":"/drugs/datopotamab-deruxtecan/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"oleclumab","kind":"drug","name":"Oleclumab","route":"/drugs/oleclumab/"},{"id":"trastuzumab-deruxtecan","kind":"drug","name":"Trastuzumab deruxtecan","route":"/drugs/trastuzumab-deruxtecan/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct03742102-ann-oncol-2026","kind":"paper","name":"Datopotamab deruxtecan (Dato-DXd) in combination with durvalumab as first-line treatment for unresectable locally advanced or metastatic triple-negative breast cancer: results from arms 7 and 8 of the phase Ib/II BEGONIA study","route":"/key-papers/paper-nct03742102-ann-oncol-2026/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}],"trial":[{"id":"diamond","kind":"trial","name":"DIAMOND","route":"/trials/diamond/"}]}}