Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Diabetes / Metabolic Neurology Women's Health Rheumatology Mental Health / Psychiatry Dermatology Rare Diseases Men's Health
Clinical Trial Active — Not Recruiting Phase III NCT05629585

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)

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…

📅 14 Oct 2026 ⏱ 1 min read
Active — Not Recruiting
Check the registry for current status and eligibility criteria.
Status
Active — Not Recruiting
Phase
Phase III
NCT ID
NCT05629585
Start
2022-11-28
Completion
2027-09-01
ClinicaliQ Trial Snapshot
  • 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) — Active Not Recruiting • Phase III • Oncology • NCT05629585.
  • TROPION-Breast03 Summary.
  • New cancer drug Dato-DXd, with or without immunotherapy, tested against standard treatment in triple-negative breast cancer patients with remaining disease after chemotherapy.

Verify eligibility, endpoints and current status on the original ClinicalTrials.gov registry before acting on this summary.

Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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. Conditions: Breast Cancer Interventions: Dato-DXd, Durvalumab, Capecitabine, Pembrolizumab Lead Sponsor: AstraZeneca Planned Enrollment: 1174 participants

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Durvalumab with platinum-based chemotherapy, then with or without olaparib, for untreated advanced or recurrent endometrial cancer
Oncology · 09 Sep 2026
Durvalumab combined with platinum-based chemotherapy is the recommended first-line treatment for untreated advanced or recurrent endometrial cancer, with olaparib addition considered based…
View guideline →
Guideline
Trastuzumab deruxtecan for treating HER2-low metastatic or unresectable breast cancer after chemotherapy
Oncology · 07 Oct 2026
Trastuzumab deruxtecan is recommended by NICE as a treatment option for HER2-low metastatic or unresectable breast cancer, making it suitable for patients…
View guideline →
Clinical Brief
New hope for breast cancer patients as life-extending drug now on NHS in England
Oncology · BBC Health · 16 Sep 2026
Enhertu is now available on the NHS in England, extending median overall survival by approximately seven months in eligible breast cancer patients…
View brief →
Clinical Brief
Cancer patient told she will get drug which could make her life longer
Oncology · BBC Health · 17 Sep 2026
Sacituzumab govitecan is now available on the NHS for patients with incurable (metastatic triple-negative) breast cancer, following a revised cost-effectiveness assessment after…
View brief →
Clinical Brief
Heart trial after breast cancer has ‘improved my life’
Oncology · BBC Health · 02 Sep 2026
Women completing breast cancer treatment can safely discontinue cardioprotective medications (likely ACE inhibitors/beta-blockers) without adverse cardiac outcomes, based on evidence from a…
View brief →
Clinical Brief
Pope does not need further treatment after lung cancer surgery
Oncology · BBC Health · 21 Oct 2026
Localised lung adenocarcinoma identified post-operatively, indicating early-stage disease suitable for surgical intervention alone No adjuvant therapy deemed necessary following successful surgical resection…
View brief →