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 with Residual Disease at the Time of Surgery Following Neoadjuvant Therapy.
- Conditions
- Stage I-III triple-negative breast cancer with residual invasive disease after neoadjuvant therapy.MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-002680-30-DK
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1075
1. Participant must be = 18 years at the time of screening; Male or female;
2. Histologically confirmed invasive TNBC.?
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 taxane with or without carboplatin, with or without pembrolizumab.
5. No evidence of locoregional or distance relapse
6. Surgical removal of all clinically evident disease in the breast and lymph nodes
7. FFPE tumor sample from residual invasive disease at surgery
8. No adjuvant systemic therapy. Radiotherapy (if indicated) delivered before start of study treatment
9. No more than 6 weeks between completion of post-operative radiation therapy and randomization. If no post-operative radiation therapy, no more than 16 weeks between the date of breast surgery and randomization?
10. Eligible for one of the therapy options listed as ICT?
11. No known germline BRCA1 or BRCA 2 mutation
12. Adequate organ and bone marrow function; LVEF = 50% by echocardiogram or MUGA; ECOG 0 or 1?
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 537
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 538
1. Stage IV (metastatic) TNBC?
2. History of prior invasive breast cancer or evidence of recurrent disease following preoperative therapy and surgery?
3. Prior anticancer therapy with topoisomerase I ADC, TROP2-targeted therapy (e.g., Trodelvy), participated in clinical studies with T-DXd?
4. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab?
5. 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?; infections; active or uncontrolled HBC or HCV; HIV; active TB
6. Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade =1?
7. History of ILD or severe pulmonary function compromise?
8. Clinically significant corneal disease?
9. Any known active or prior documented autoimmune or inflammatory disorders?
10. Any known active liver disease?
11. Uncontrolled or significant cardiac disease?
12. Grade =2 peripheral neuropathy of any etiology?
13. History of severe hypersensitivity to either drug substances or inactive ingredients of Dato-DXd or history of hypersensitivity to PD-1/PD-L1 inhibitors or capecitabine?
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method