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New treatment option for Invasive Breast Cancer
Official title TRUDI: TDXD+Durva in HER2+/Low IBC
ClinicalTrials.gov ID: NCT05795101
What this study is testing
What is Trastuzumab deruxtecan?
Trastuzumab deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for invasive breast cancer.
Also referred to as Enhertu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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 the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH...
- Any ER and PR expressions are permitted but must be known
You likely can't join if
- Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or...
- Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the...
- Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to...
- Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled...
- Participant has a medical condition that requires chronic systemic steroid therapy (\> 10 mg of prednisone daily or equivalent) or any other form of...
See the full eligibility criteria
Who can join
- 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 the current ASCO/CAP guidelines or HER2-low tumor expression (IHC 2+/ISH-, IHC 1+/ISH-, or IHC 1+/ISH untested) (note: ISH may be determined by either fluorescence in situ...
- Any ER and PR expressions are permitted but must be known
- Participants must be treatment-naïve
- Participants must agree to undergo two research biopsies of the tumor (if safely accessible, as determined by the treating investigator): at baseline (prior to the first treatment) and after the first week of treatment...
- Pre- and postmenopausal women or male patients ≥ 18 years of age
- ECOG performance status 0-1 (Karnofsky \> 60%, see Appendix A).
- LVEF ≥ 50% within 28 days prior to enrollment
- Participants must have normal organ and marrow function prior to enrollment as defined below:
- Absolute neutrophil count ≥2,000/mcL
- Platelets ≥100,000/mcL
- Hemoglobin ≥ 9.0 g/dl
- INR/PT/aPTT ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is in therapeutic range of anticoagulant
- Total bilirubin ≤1.5 × institutional upper limit of normal (ULN)(or ≤2.0 x ULN in patients with documented Gilbert's Syndrome)
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN
- Serum creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 30 mL/min/ 1.73m2 for participants with creatinine levels above institutional ULN.
- Serum albumin ≥2.5 g/dL
- International normalized ratio (INR)/prothrombin time (PT) and either partial thromboplastin or activated partial thromboplastin time (aPTT) ≤1.5 × ULN
- Women of childbearing potential (WOCBP) and WOCBP who are partners of male participants must agree to use one highly effective non-hormonal form of contraception or two effective forms of non-hormonal contraception for...
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with durvalumab and 4 months after the last dose of study treatment
- Must have a life expectancy of at least 12 weeks
- Body weight \>30 kg
- The participant must be capable of understanding and complying with the protocol and willing to sign a written informed consent document
What rules you out
- Has received prior systemic anti-cancer therapy for the current diagnosis of inflammatory breast cancer, including chemotherapy, immunotherapy, or targeted therapy
- Has received any radiotherapy or surgery for the current diagnosis of inflammatory breast cancer. Tumor biopsies are not considered surgery for the purpose of enrollment.
- Prior hypersensitivity to durvalumab or the excipients of durvalumab or trastuzumab deruxtecan or history of severe hypersensitivity reactions to other monoclonal antibodies.
- Major surgery within 4 weeks prior to study treatment initiation. Patients must have recovered from any effects of any major surgery.
- Uncontrolled intercurrent illness, including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia...
- Participant has a medical condition that requires chronic systemic steroid therapy (\> 10 mg of prednisone daily or equivalent) or any other form of immunosuppressive medication (including disease modifying agents) and...
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus...
- History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the study enrollment, severe asthma, severe chronic...
- Corrected QT interval (QTcF) prolongation to \> 470 msec on screening EKG
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome...
- Any of the following procedures or conditions in the 6 months prior to enrollment: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure (New York...
- Cardiac ejection fraction outside institutional range of normal or \<50% (whichever is higher) as measured by echocardiogram (or multiple-gated acquisition [MUGA] scan if an echocardiogram cannot be performed or is...
- History of another primary malignancy, except for Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study treatment and of low potential risk for recurrence...
- History of venous thromboembolism in the past 3 months.
- History of active primary immunodeficiency.
- Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known...
- Known to have previously tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies)(HIV testing is not required for participation on this study)
- Receipt of a live vaccine within 30 days prior to study treatment initiation. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies...
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is...
- Use of potent inhibitors or inducers or substrates of CYP3A4 or substrates of CYP2C9 or CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
- Use of hydroxychloroquine in \<14 days prior to Day 1 of trastuzumab deruxtecan treatment
- History of leptomeningeal carcinomatosis
- Female patients who are pregnant, breastfeeding or of reproductive potential who are not willing to employ effective birth control from screening to 6 months after the last dose of durvalumab and at least 7 months after...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.