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)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05629585
• Collaborator: Daiichi Sankyo, Inc. (Industry), SWOG Clinical Trials Partnerships (Other)
• Enrollment: 1,075
• Locations: 166
• Arms: 3
• Anticipated Duration (Months): 87.9
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Dato-DXd; Drug: Durvalumab; Drug: Capecitabine; Drug: Pembrolizumab	Phase 3

Detailed Description

The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.

The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1075 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: ParallelParallel
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
• Actual Study Start Date: Nov 28, 2022
• Anticipated Primary Completion Date: Sep 20, 2027
• Anticipated Study Completion Date: Mar 27, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dato-DXd in combination with Durvalumab Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles	Drug: Dato-DXd; Experimental drug. Provided in 100mg vials. IV infusion; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a) ; Drug: Durvalumab; Experimental drug. Provided in 50mg vials. IV infusion; Other Names: MEDI4736
Experimental: Dato-DXd Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles	Drug: Dato-DXd; Experimental drug. Provided in 100mg vials. IV infusion; Other Names: Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Active Comparator: Investigators Choice Therapy Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles * Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3.	Drug: Capecitabine; Active Comparator. Tablet. Oral route of administration; Other Names: XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord ; Drug: Pembrolizumab; Active Comparator. Provided in 100mg vials. IV infusion; Other Names: KEYTRUDA®

Outcome Measures

Primary Outcome Measures

1. Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT [From randomization until recurrence as assessed by investigator or death due to any cause up to 57 months from first subject in]

   iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs ICT.

Secondary Outcome Measures

1. Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT [Randomization to date of the event, up to 57 months from first subject in]

   DDFS is defined as time from randomization to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The analysis will include all randomized participants, as randomized regardless of whether the participant withdraws from randomized therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs ICT.

2. DDFS for Dato-DXd vs ICT [Randomization to date of the event, up to 57 months from first subject in]

   DDFS is defined as time from randomization to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR of DDFS for Dato-DXd vs ICT.

3. DDFS for Dato-DXd + durvalumab vs Dato-DXd [Randomization to date of the event, up 57 months from first subject in]

   DDFS is defined as time from randomization to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR of DDFS for Dato-DXd + durvalumab vs Dato-DXd.

4. Overall Survival (OS) for Dato-DXd + durvalumab vs ICT [Randomization to date of death, due to any cause, up to 87 months from first subject in]

   OS is defined as time from randomization until date of death due to any cause. The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd + durvalumab vs ICT.

5. OS for Dato-DXd vs ICT [Randomization to date of death, due to any cause, up to 87 months from first subject in]

   OS is defined as time from randomization until date of death due to any cause. The measure of interest will be the HR of OS for Dato-DXd vs ICT.

6. iDFS for Dato-DXd vs ICT [Randomization to event, up to 57 months from first subject in]

   iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy. The measure of interest will be the HR of iDFS for Dato-DXd vs ICT.

7. iDFS for Dato-DXd + durvalumab vs Dato-DXd [Randomization to event, up to 57 months from first subject in]

   iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. The measure of interest will be the HR of iDFS for Dato-DXd + durvalumab vs Dato-DXd.

8. Time to Deterioration (TTD) in physical functioning in participants treated with Dato-DXd with or without durvalumab compared with ICT [Randomization to date of the event, up to 36 months after randomization]

   TTD in physical function as measured by the PROMIS Physical Function Short Form 8c.TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all dosed participants. The measure of interest is the HR (hazard ratio) of TTD in physical function for Dato-DXd with or without durvalumab compared with ICT.

9. Time to Deterioration (TTD) in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT [Randomization to date of the event, up to 36 months after randomization]

   TTD in GHS/QoL as measured by the GHS/QoL scale from the EORTC IL172. TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold. The analysis will include all randomised participants. The measure of interest is the HR (hazard ratio) of TTD in GHS/QoL for Dato-DXd with or without durvalumab compared with ICT.

10. Fatigue in participants treated with Dato-DXd with or without durvalumab vs ICT [Randomization to 24 months after randomization]

    Proportion of participants experiencing different levels of fatigue at 3 months (13weeks), 6 months (26 weeks), and 12 months (52 weeks) as measured by PROMIS Fatigue Short Form 7a. The analysis will include all dosed participants. The measure of interest will be the proportion of participants reporting different levels of fatigue.

11. Pharmacokinetics of Dato-DXd [Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days)]

    Concentration of Dato- DXd, total anti-TROP2 antibody, and MAAA-1181 in plasma.

12. Immunogenicity of Dato-DXd [Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days) and within 35 days of completion of or discontinuation of study intervention (at an average of 6 months following randomization)]

    Presence of ADAs for Dato-DXd (confirmatory results: positive or negative; titres).

13. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely]

    Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 130 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participant must be ≥ 18 years at the time of screening.

2. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.

3. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.

4. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab.

5. No evidence of locoregional or distant relapse.

6. Surgical removal of all clinically evident disease in the breast and lymph nodes.

7. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.

8. All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis.

9. No adjuvant systemic therapy.

10. Radiotherapy (if indicated) delivered before the start of study intervention.

11. If post-operative radiation therapy is given, an interval of no more than 6 weeks between the completion of radiation therapy and the date of randomisation (radiation therapy can be completed during screening period). If no post-operative radiation therapy is given, an interval of no more than 16 weeks between the date of breast surgery and the date of randomisation.

12. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.

13. Eligible for one of the therapy options listed as investigator's choice per investigator assessment.

14. No known germline BRCA1 or BRCA2 mutation.

15. Adequate bone marrow reserve and organ function within 7 days before randomisation.

Exclusion Criteria:

1. Stage IV (metastatic) TNBC.

2. History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.

3. 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 .

4. 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 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.

5. 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).

6. Active or prior documented autoimmune or inflammatory disorders.

7. Clinically significant corneal disease.

8. Active or uncontrolled hepatitis B or C virus infection.

9. Known to have tested positive for HIV (positive HIV 1/2 antibodies).

10. Active tuberculosis infection.

11. Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening.

12. Uncontrolled or significant cardiac disease.

13. History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

14. Clinically severe pulmonary function compromise resulting from intercurrent pulmonary illnesses.

15. Any known active liver disease.

16. Grade ≥ 2 peripheral neuropathy of any aetiology.

17. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab.

18. Current or prior use of immunosuppressive medication within 14 days prior to randomisation.

19. Participants with a known severe hypersensitivity to Dato-DXd or any of the excipients of these products including but not limited to polysorbate 80 or other monoclonal antibodies.

20. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors.

21. Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to randomisation, randomisation into a prior Dato-DXd, T-DXd, or durvalumab study regardless of treatment assignment.

22. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Gilbert	Arizona	United States	85234
2	Research Site	Little Rock	Arkansas	United States	72205
3	Research Site	Springdale	Arkansas	United States	72762
4	Research Site	Beverly Hills	California	United States	90211
5	Research Site	Duarte	California	United States	91010
6	Research Site	Fountain Valley	California	United States	92708
7	Research Site	Harbor City	California	United States	90710
8	Research Site	Los Angeles	California	United States	90017
9	Research Site	Los Angeles	California	United States	90095
10	Research Site	Orange	California	United States	92868
11	Research Site	Aurora	Colorado	United States	80045
12	Research Site	New Haven	Connecticut	United States	06510
13	Research Site	Newark	Delaware	United States	19713
14	Research Site	Fort Myers	Florida	United States	33901
15	Research Site	Saint Petersburg	Florida	United States	33705
16	Research Site	West Palm Beach	Florida	United States	33401
17	Research Site	Atlanta	Georgia	United States	30318
18	Research Site	Atlanta	Georgia	United States	30322
19	Research Site	Marietta	Georgia	United States	30060
20	Research Site	Honolulu	Hawaii	United States	96813
21	Research Site	Maywood	Illinois	United States	60153
22	Research Site	Iowa City	Iowa	United States	52242
23	Research Site	Westwood	Kansas	United States	66205
24	Research Site	Lexington	Kentucky	United States	40503
25	Research Site	Louisville	Kentucky	United States	40202
26	Research Site	Louisville	Kentucky	United States	40241
27	Research Site	Baton Rouge	Louisiana	United States	70809
28	Research Site	New Orleans	Louisiana	United States	70121
29	Research Site	Baltimore	Maryland	United States	21201
30	Research Site	Baltimore	Maryland	United States	21202
31	Research Site	Boston	Massachusetts	United States	02114
32	Research Site	Saint Louis	Missouri	United States	63110
33	Research Site	Billings	Montana	United States	59102
34	Research Site	Camden	New Jersey	United States	08103
35	Research Site	Hackensack	New Jersey	United States	07601
36	Research Site	Albuquerque	New Mexico	United States	87102
37	Research Site	New York	New York	United States	10021
38	Research Site	New York	New York	United States	10065
39	Research Site	Charlotte	North Carolina	United States	28204
40	Research Site	Cleveland	Ohio	United States	44195
41	Research Site	Hershey	Pennsylvania	United States	17033
42	Research Site	Philadelphia	Pennsylvania	United States	19104
43	Research Site	Philadelphia	Pennsylvania	United States	19111
44	Research Site	Pittsburgh	Pennsylvania	United States	15212
45	Research Site	Pittsburgh	Pennsylvania	United States	15213
46	Research Site	Providence	Rhode Island	United States	02903
47	Research Site	Chattanooga	Tennessee	United States	37404
48	Research Site	Nashville	Tennessee	United States	37203
49	Research Site	Fort Worth	Texas	United States	76104
50	Research Site	Houston	Texas	United States	77030
51	Research Site	Midlothian	Virginia	United States	23114
52	Research Site	Kennewick	Washington	United States	99336
53	Research Site	Seattle	Washington	United States	98104
54	Research Site	Spokane Valley	Washington	United States	99216
55	Research Site	Madison	Wisconsin	United States	53792
56	Research Site	Milwaukee	Wisconsin	United States	53226
57	Research Site	Anderlecht		Belgium	1070
58	Research Site	Brussel		Belgium	1090
59	Research Site	Bruxelles		Belgium	1200
60	Research Site	Charleroi		Belgium	6000
61	Research Site	Edegem		Belgium	2650
62	Research Site	Gent		Belgium	9000
63	Research Site	Hasselt		Belgium	3500
64	Research Site	Liège		Belgium	4000
65	Research Site	Sint-Niklaas		Belgium	9100
66	Research Site	Wilrijk		Belgium	2610
67	Research Site	Sao Paulo		Brazil	01508-010
68	Research Site	North Vancouver	British Columbia	Canada	V7L 2L7
69	Research Site	Barrie	Ontario	Canada	L4M 6M2
70	Research Site	Oakville	Ontario	Canada	L9T 6G2
71	Research Site	Ottawa	Ontario	Canada	K1H 8L6
72	Research Site	Toronto	Ontario	Canada	M5G 1X5
73	Research Site	Toronto	Ontario	Canada	M5G 2M9
74	Research Site	Montreal	Quebec	Canada	H2X 0C1
75	Research Site	Montreal	Quebec	Canada	H3T 1E2
76	Research Site	Montreal	Quebec	Canada	H4A 3J1
77	Research Site	Quebec City	Quebec	Canada	G1S 4L8
78	Research Site	Saskatoon	Saskatchewan	Canada	S7N 4H4
79	Research Site	Beijing		China	100044
80	Research Site	Beijing		China	100142
81	Research Site	Bengbu		China	233060
82	Research Site	Changchun		China	130021
83	Research Site	Changsha		China	410008
84	Research Site	Chengdu		China	610000
85	Research Site	Chengdu		China	610072
86	Research Site	Chongqing		China	400030
87	Research Site	Fuzhou		China	350011
88	Research Site	Guangzhou		China	510060
89	Research Site	Guangzhou		China	510100
90	Research Site	Guangzhou		China	510120
91	Research Site	Guangzhou		China	510700
92	Research Site	Haikou		China	570311
93	Research Site	Hangzhou		China	310020
94	Research Site	Harbin		China	150081
95	Research Site	Hefei		China	230001
96	Research Site	Jinan		China	250030
97	Research Site	Nanchang		China	330009
98	Research Site	Nanjing		China	210008
99	Research Site	Nanning		China	530021
100	Research Site	Qingdao		China	110016
101	Research Site	Shanghai		China	200025
102	Research Site	Shanghai		China	200032
103	Research Site	Shenzhen		China	518020
104	Research Site	Taiyuan		China	030000
105	Research Site	Tianjin		China	300060
106	Research Site	Wuhan		China	430022
107	Research Site	Wuhan		China	430060
108	Research Site	Xiamen		China	361003
109	Research Site	Zhengzhou		China
110	Research Site	Augsburg		Germany	86156
111	Research Site	Frankfurt am Main		Germany	65929
112	Research Site	Hamburg		Germany	20357
113	Research Site	Heilbronn		Germany	74078
114	Research Site	Kiel		Germany	24105
115	Research Site	Langen		Germany	63225
116	Research Site	Ludwigsburg		Germany	71640
117	Research Site	Mönchengladbach		Germany	41061
118	Research Site	München		Germany	80337
119	Research Site	Troisdorf		Germany	53840
120	Research Site	Tübingen		Germany	72076
121	Research Site	Witten		Germany	58452
122	Research Site	Wuppertal		Germany	42283
123	Research Site	Brescia		Italy	25123
124	Research Site	Roma		Italy	00168
125	Research Site	Hiroshima-shi		Japan	730-8518
126	Research Site	Osaka-shi		Japan	541-8567
127	Research Site	Yokohama-shi		Japan	241-8515
128	Research Site	Busan		Korea, Republic of	49241
129	Research Site	Daegu		Korea, Republic of	41404
130	Research Site	Goyang-si		Korea, Republic of	10408
131	Research Site	Seongnam-si		Korea, Republic of	463-712
132	Research Site	Seoul		Korea, Republic of	02841
133	Research Site	Seoul		Korea, Republic of	03722
134	Research Site	Seoul		Korea, Republic of	05505
135	Research Site	Seoul		Korea, Republic of	06273
136	Research Site	Seoul		Korea, Republic of	06351
137	Research Site	Seoul		Korea, Republic of	13620
138	Research Site	Barcelona		Spain	08028
139	Research Site	Barcelona		Spain	8035
140	Research Site	Bilbao (Vizcaya)		Spain	48013
141	Research Site	Elche(Alicante)		Spain	03202
142	Research Site	Madrid		Spain	28040
143	Research Site	Madrid		Spain	28041
144	Research Site	Malaga		Spain	29010
145	Research Site	Palma de Mallorca		Spain	07010
146	Research Site	Toledo		Spain	45007
147	Research Site	Valencia		Spain	46010
148	Research Site	Hsinchu		Taiwan	300
149	Research Site	Taichung		Taiwan	40447
150	Research Site	Tainan City		Taiwan	70403
151	Research Site	Taipei		Taiwan	10002
152	Research Site	Taipei		Taiwan	10449
153	Research Site	Taipei		Taiwan	112
154	Research Site	Taoyuan		Taiwan	333
155	Research Site	Yung Kang City		Taiwan	71044
156	Research Site	Cambridge		United Kingdom	CB2 0QQ
157	Research Site	Cardiff		United Kingdom	CF14 2TL
158	Research Site	Derry		United Kingdom	BT47 6SB
159	Research Site	Edinburgh		United Kingdom	EH4 2XU
160	Research Site	Greater London		United Kingdom	SW3 6JJ
161	Research Site	London		United Kingdom	EC1A 7BE
162	Research Site	London		United Kingdom	SE1 9RT
163	Research Site	Manchester		United Kingdom	M20 4BX
164	Research Site	Newcastle upon Tyne		United Kingdom	NE7 7AF
165	Research Site	Surrey		United Kingdom	SM2 5PT
166	Research Site	Taunton		United Kingdom	TA1 5DA

Sponsors and Collaborators

• AstraZeneca
• Daiichi Sankyo, Inc.
• SWOG Clinical Trials Partnerships

Investigators

• Study Chair: Aditya Bardia, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT05629585
• Other Study ID Numbers: D926XC00001
• First Posted: Nov 29, 2022
• Last Update Posted: Jan 18, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AstraZeneca: Breast Cancer; TNBC; Triple-negative; Adjuvant; Datopotamab Deruxtecan; Dato-DXd; DS1062a; Antibody Drug Conjugate; ADC; TROP2; Durvalumab
• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Pembrolizumab; Durvalumab; Capecitabine

Study Results

No Results Posted as of Jan 18, 2023