A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
Study identifier:D926QC00001
ClinicalTrials.gov identifier:NCT06112379
EudraCT identifier:N/A
CTIS identifier:N/A
Recruiting
Official Title
A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)
Medical condition
Breast Cancer
Phase
Phase 3
Healthy volunteers
No
Study drug
Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin, Capecitabine, Olaparib
Sex
All
Estimated Enrollment
1728
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 14 Nov 2023
Estimated Primary Completion Date: 29 Mar 2028
Estimated Study Completion Date: 28 Aug 2030
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Daiichi Sankyo
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Dato-DXd plus durvalumab Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease Adjuvant chemotherapy may be one of these: 1) Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks); 2) Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks); 3) Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks); 4) Capecitabine (Q3W) for 8 cycles. | Drug: Dato-DXd Experimental drug IV infusion Other Name: Datopotamab deruxtecan (Dato-DXd, DS-1062a) Drug: Durvalumab Experimental drug IV Infusion Other Name: MEDI4736 Drug: Doxorubicin IV infusion Experimental/Active Comparator Drug: Epirubicin IV Infusion Experimental/Active Comparator Drug: Cyclophosphamide IV infusion Experimental/Active Comparator Drug: Paclitaxel IV infusion Experimental/Active Comparator Drug: Carboplatin IV infusion Experimental/Active Comparator Drug: Capecitabine Tablet Oral route of administration Experimental/Active Comparator Other Name: XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord Drug: Olaparib Tablet Oral route of administration Experimental/Active Comparator Other Name: LYNPARZA® |
| Active Comparator: Pembrolizumab plus chemotherapy Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease. | Drug: Pembrolizumab IV Infusion Active comparator Other Name: KEYTRUDA® Drug: Doxorubicin IV infusion Experimental/Active Comparator Drug: Epirubicin IV Infusion Experimental/Active Comparator Drug: Cyclophosphamide IV infusion Experimental/Active Comparator Drug: Paclitaxel IV infusion Experimental/Active Comparator Drug: Carboplatin IV infusion Experimental/Active Comparator Drug: Capecitabine Tablet Oral route of administration Experimental/Active Comparator Other Name: XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord Drug: Olaparib Tablet Oral route of administration Experimental/Active Comparator Other Name: LYNPARZA® |
