# A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer

Source: https://onco.cc/trials/nct03742102/  
OnCo record `nct03742102` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Also known as: BEGONIA
- Tags: pipeline; ctgov-ingest
- Registry id: 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
- Enrolled: 243
- Outcomes: Dose Limiting Toxicity (DLT) Events: Arm 2 0 participants vs Arm 5 0 participants vs Arm 6 0 participants vs Arm 7 0 participants; Overall Survival (Duration): Arm 1 30 months vs Arm 2 32.6 months vs Arm 5 24.8 months vs Arm 6 30.3 months vs Arm 7 vs Arm 8; Progression-free Survival (PFS): Arm 1 7.3 months vs Arm 2 6.4 months vs Arm 5 8.3 months vs Arm 6 12.6 months vs Arm 7 14 months vs Arm 8 11.2 months

## 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.

## Sources

- ClinicalTrials.gov NCT03742102: https://clinicaltrials.gov/study/NCT03742102
- BEGONIA arms 7 and 8 (Annals of Oncology 2026): https://doi.org/10.1016/j.annonc.2026.05.693

## Connected records

- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/)
- drugs: [Capivasertib](https://onco.cc/drugs/capivasertib/), [Datopotamab deruxtecan](https://onco.cc/drugs/datopotamab-deruxtecan/), [Durvalumab](https://onco.cc/drugs/durvalumab/), [Oleclumab](https://onco.cc/drugs/oleclumab/), [Trastuzumab deruxtecan](https://onco.cc/drugs/trastuzumab-deruxtecan/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- key papers: [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](https://onco.cc/key-papers/paper-nct03742102-ann-oncol-2026/)
- terms: [Triple-negative breast cancer trials open today (registry snapshot and UK sites)](https://onco.cc/terms/tnbc-trials-open-today/)
- trials: [DIAMOND](https://onco.cc/trials/diamond/)

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