Actively Recruiting
TRUDI: TDXD+Durva in HER2+/Low IBC
Led by Filipa Lynce, MD · Updated on 2025-09-19
63
Participants Needed
3
Research Sites
499 weeks
Total Duration
On this page
Sponsors
F
Filipa Lynce, MD
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test the safety and effectiveness of an investigational drug combination (trastuzumab deruxtecan and durvalumab) to learn whether the intervention works in treating Human Epidermal growth factor Receptor-2 (HER2)-expressing inflammatory breast cancer. The names of the study drugs involved in this study are: * Trastuzumab deruxtecan * Durvalumab
CONDITIONS
Official Title
TRUDI: TDXD+Durva in HER2+/Low IBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a histological or cytological diagnosis of invasive breast cancer.
- All histologic subtypes are eligible.
- Participants must have a clinical diagnosis of stage III inflammatory breast cancer within the past 6 months
- HER2-positive status as determined locally by ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested)
- Any estrogen receptor (ER) and progesterone receptor (PR) expressions are permitted but must be known
- Participants must be treatment-nafve
- Participants must agree to undergo two research biopsies of the tumor if safely accessible: at baseline and after first week of treatment on cycle 1 day 8
- Pre- and postmenopausal women or male patients 18 years or older
- ECOG performance status 0-1 (Karnofsky > 60%)
- Left ventricular ejection fraction (LVEF) 50% or higher within 28 days prior to enrollment
- Normal organ and marrow function with specified blood count and chemistry levels
- Women of childbearing potential and partners must agree to use specified contraception during and after study treatment
- Male participants sexually active with women of childbearing potential must use contraception during and after study treatment
- Life expectancy of at least 12 weeks
- Body weight over 30 kg
- Ability to understand and comply with protocol and willing to sign informed consent
You will not qualify if you...
- Prior systemic anti-cancer therapy for current inflammatory breast cancer diagnosis
- Prior radiotherapy or surgery for current inflammatory breast cancer diagnosis (tumor biopsies allowed)
- Prior hypersensitivity to durvalumab or trastuzumab deruxtecan or severe reactions to other monoclonal antibodies
- Major surgery within 4 weeks before starting study treatment
- Uncontrolled illnesses including infections, heart failure, uncontrolled hypertension, unstable angina, or serious gastrointestinal or psychiatric conditions limiting compliance
- Medical conditions requiring chronic systemic steroid or immunosuppressive therapy within last 2 years
- Active or prior autoimmune or inflammatory disorders except certain controlled conditions
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected cases not ruled out
- Significant lung diseases or prior pneumonectomy
- Corrected QT interval over 470 msec or risk factors for QT prolongation or arrhythmia
- Recent major cardiac events or abnormalities including heart failure or stroke
- Cardiac ejection fraction below institutional normal or less than 50%
- History of another primary malignancy within past 5 years except certain treated cancers
- Venous thromboembolism in past 3 months
- Active infections including tuberculosis, hepatitis B or C, or HIV
- Receipt of live vaccine within 30 days prior to treatment
- Conditions or factors that may interfere with study participation or safety
- Use of certain medications affecting drug metabolism within 2 weeks prior to treatment
- History of leptomeningeal carcinomatosis
- Pregnancy, breastfeeding, or unwillingness to use effective birth control during and after treatment due to risks to fetus or infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
F
Filipa Lynce, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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