Actively Recruiting
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
Led by AstraZeneca · Updated on 2026-05-12
100
Participants Needed
40
Research Sites
117 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
D
Daiichi Sankyo
Collaborating Sponsor
AI-Summary
What this Trial Is About
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
CONDITIONS
Official Title
A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years or older at screening.
- Diagnosed with inoperable or metastatic hormone receptor-positive, HER2 IHC 0 breast cancer.
- Cancer has progressed on endocrine therapy and is unsuitable for further endocrine treatment.
- ECOG performance status of 0 or 1, stable for at least 2 weeks before treatment start.
- Life expectancy of at least 12 weeks.
- Able to provide an acceptable tumor sample collected within 6 weeks before treatment or retrospectively.
- Has measurable or evaluable disease per RECIST 1.1 criteria.
- Adequate bone marrow and organ function within 7 days before treatment, including specific blood counts and liver/kidney function.
- Male or female of any gender identity.
- Willing to follow contraceptive guidelines appropriate to gender and reproductive status.
- Able to provide informed consent and comply with study requirements.
- All races, genders, and ethnic groups are eligible.
You will not qualify if you...
- Presence of severe or uncontrolled systemic diseases, active bleeding, significant cardiac or psychological conditions, substance abuse, or history of organ transplant judged unsuitable for study participation.
- History of other primary cancers except those treated curatively with no active disease within 3 years, excluding certain skin cancers and in situ diseases.
- Ongoing toxicities from prior cancer treatments above Grade 1, except stable chronic Grade 2 toxicities deemed acceptable.
- Spinal cord compression or brain metastases unless asymptomatic and stable without recent corticosteroid or anticonvulsant treatment.
- Presence of leptomeningeal carcinomatosis or metastasis.
- Significant fluid retention not manageable by drainage.
- Clinically significant corneal disease.
- Active or uncontrolled hepatitis B or C infection unless meeting specific clinical criteria.
- Known uncontrolled HIV infection.
- Uncontrolled infections requiring intravenous treatment or suspected infections that cannot be ruled out.
- Active tuberculosis infection.
- Abnormal resting ECG.
- Uncontrolled or significant cardiac disease including recent myocardial infarction, heart failure, uncontrolled hypertension, or serious arrhythmias.
- History or current non-infectious interstitial lung disease or pneumonitis requiring steroids.
- Severe pulmonary function impairment.
- Prior treatment with TROP2-targeted therapy, topoisomerase I-targeted chemotherapy, or chemotherapy in metastatic setting.
- Recent use of chloroquine/hydroxychloroquine without sufficient washout.
- Recent anticancer therapy within specified timeframes.
- Concurrent anticancer treatment except certain bone therapies and allowed hormonal treatments.
- Recent radiotherapy to chest or wide field bone radiation within specified timeframes.
- Use of systemic corticosteroids above specified doses unless for adverse event management.
- Recent major surgery or significant injury.
- Participation in other clinical studies with investigational treatments within specified timeframes.
- Known severe hypersensitivity to Dato-DXd or similar monoclonal antibodies.
- Study staff or site personnel involved in study planning or conduct.
- Inability or unwillingness to comply with study procedures.
- Previous enrollment in this study.
- Pregnant or breastfeeding females or planning pregnancy.
- Contraindications to steroid-containing mouthwash use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 40 locations
1
Research Site
Largo, Florida, United States, 33770
Withdrawn
2
Research Site
Fort Wayne, Indiana, United States, 46825
Actively Recruiting
3
Research Site
Omaha, Nebraska, United States, 68130
Actively Recruiting
4
Research Site
New York, New York, United States, 10021
Not Yet Recruiting
5
Research Site
Houston, Texas, United States, 77024
Actively Recruiting
6
Research Site
Puyallup, Washington, United States, 98373
Actively Recruiting
7
Research Site
Beijing, China, 100021
Actively Recruiting
8
Research Site
Changsha, China, 410013
Not Yet Recruiting
9
Research Site
Guangzhou, China, 510060
Actively Recruiting
10
Research Site
Linyi, China, 276001
Actively Recruiting
11
Research Site
Shandong, China, 250117
Not Yet Recruiting
12
Research Site
Wuhan, China, 430071
Not Yet Recruiting
13
Research Site
Zhengzhou, China, 450008
Not Yet Recruiting
14
Research Site
Clermont-Ferrand, France, 63050
Actively Recruiting
15
Research Site
La Roche-sur-Yon, France, 85925
Actively Recruiting
16
Research Site
Montpellier, France, 34070
Actively Recruiting
17
Research Site
Paris, France, 75005
Actively Recruiting
18
Research Site
Pierre-Bénite, France, 69310
Actively Recruiting
19
Research Site
Aviano, Italy, 33081
Actively Recruiting
20
Research Site
Florence, Italy, 50134
Actively Recruiting
21
Research Site
Meldola, Italy, 47014
Actively Recruiting
22
Research Site
Milan, Italy, 20141
Actively Recruiting
23
Research Site
Naples, Italy, 80131
Actively Recruiting
24
Research Site
Roma, Italy, 00168
Actively Recruiting
25
Research Site
Bukgu, South Korea, 41404
Actively Recruiting
26
Research Site
Goyang-si, South Korea, 410-769
Actively Recruiting
27
Research Site
Seoul, South Korea, 03080
Actively Recruiting
28
Research Site
Seoul, South Korea, 06273
Actively Recruiting
29
Research Site
Seoul, South Korea, 06351
Actively Recruiting
30
Research Site
Seoul, South Korea, 06591
Actively Recruiting
31
Research Site
Seoul, South Korea, 136705
Actively Recruiting
32
Research Site
Seoul, South Korea, 3722
Actively Recruiting
33
Research Site
Seoul, South Korea, 5505
Actively Recruiting
34
Research Site
A Coruña, Spain, 15006
Actively Recruiting
35
Research Site
Barcelona, Spain, 08035
Actively Recruiting
36
Research Site
Granada, Spain, 18007
Not Yet Recruiting
37
Research Site
Madrid, Spain, 28033
Not Yet Recruiting
38
Research Site
Madrid, Spain, 28040
Actively Recruiting
39
Research Site
Seville, Spain, 41009
Actively Recruiting
40
Research Site
Valencia, Spain, 46009
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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