Actively Recruiting
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Led by AstraZeneca · Updated on 2025-11-24
100
Participants Needed
6
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A PROSPECTIVE, MULTI-CENTER, PHASE 4, SINGLE ARM STUDY TO ASSESS THE SAFETY OF TRASTUZUMAB DERUXTECAN, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE IN INDIAN PATIENTS WITH UNRESECTABLE OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED A PRIOR ANTI-HER2-BASED REGIMEN
CONDITIONS
Official Title
Phase 4 Study to Assess the Safety of Trastuzumab Deruxtecan, in Indian Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing informed consent.
- Willing and able to give signed informed consent and comply with study requirements.
- Diagnosed with unresectable or metastatic HER2-positive breast cancer confirmed by laboratory testing within the last year.
- Previously treated with an anti-HER2 regimen.
- Adequate bone marrow function within 14 days before enrollment: neutrophils ≥ 1.5 x 10^9/L, platelets ≥ 100 x 10^9/L, hemoglobin ≥ 9.0 g/dL.
- Adequate kidney function within 14 days before enrollment: creatinine clearance ≥ 30 mL/min.
- Adequate liver function within 14 days before enrollment: total bilirubin ≤ 1.5 times upper limit of normal (ULN) or <3 times ULN in certain conditions; AST/ALT ≤ 3 times ULN.
- Adequate blood clotting function within 14 days before enrollment: INR/PT and PTT/APTT ≤ 1.5 times ULN.
- Female participants of childbearing potential must agree to use highly effective contraception during and for 7 months after treatment; males must agree to inform partners and use contraception during and for 4.5 months after treatment.
- Male participants must not freeze or donate sperm during the study and for 4.5 months after last dose.
- Female participants must not donate or retrieve ova during the study and for 7 months after last dose.
You will not qualify if you...
- Prior treatment with trastuzumab deruxtecan.
- Uncontrolled or significant cardiovascular disease, including recent myocardial infarction, symptomatic heart failure, prolonged QT interval, or left ventricular ejection fraction below 50%.
- History of interstitial lung disease or pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis not ruled out.
- Spinal cord compression or active central nervous system metastases requiring treatment; stable treated brain metastases allowed.
- Severe allergic reactions to trastuzumab deruxtecan or similar drugs.
- Uncontrolled infections needing intravenous antibiotics, antivirals, or antifungals.
- Known HIV infection or active hepatitis B or C.
- Unresolved toxicities from prior cancer treatments above grade 1, except alopecia.
- Recent major surgery or radiation therapy within specified timeframes before enrollment.
- Recent anticancer therapy within specified washout periods before enrollment.
- Participation in other therapeutic clinical studies within specified timeframes.
- Pregnant, breastfeeding, or planning pregnancy.
- Severe lung problems from other diseases or prior lung surgery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Research Site
Bangalore, India, 560017
Actively Recruiting
2
Research Site
Delhi, India, 110029
Actively Recruiting
3
Research Site
Kochi, India, 682041
Actively Recruiting
4
Research Site
Mumbai, India, 400012
Actively Recruiting
5
Research Site
Pune, India, 411028
Actively Recruiting
6
Research Site
Varanasi, India, 221005
Actively 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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here