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New treatment option for Breast Cancer Stage IV
Official title Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
ClinicalTrials.gov ID: NCT07371585
What this study is testing
What is T-DXd?
T-DXd is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for breast cancer stage iv.
Also referred to as Trastuzumab deruxtecan + Pertuzumab, Pertuzumab.
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
- This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
You may be able to join if
- Able to understand the nature of the study and to voluntarily provide written informed consent prior to any trial-specific screening procedures and...
- Male/female patients who are at least 18 years of age on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Histologically or cytologically locally confirmed HR+/HER2+ or HR-/HER2+ BC with evidence of locally advanced disease, not amenable to resection or...
- HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+) by...
You likely can't join if
- Patients with HER2-negative disease.
- people who, in the opinion of the investigator, are unable to comply with the protocol requirements or who have any comorbidity or condition that may...
- History of other primary malignancy unless treated with curative intent with no evidence of active disease within 3 years before the first dose of...
- Persistent toxicities that the investigator deems related to previous anti-cancer therapy (excluding alopecia), not yet resolved to grade ≤ 1 or...
- Untreated spinal cord compression
- History of significant cardiovascular disease, defined as:
See the full eligibility criteria
Who can join
- Able to understand the nature of the study and to voluntarily provide written informed consent prior to any trial-specific screening procedures and has sufficient cognitive capacity to comply with study requirements...
- Male/female patients who are at least 18 years of age on the day of signing informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Histologically or cytologically locally confirmed HR+/HER2+ or HR-/HER2+ BC with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent, or metastatic disease:
- HER2-positivity confirmed in a tumor sample obtained in the metastatic setting, defined as either IHC 3+ or in situ hybridization positive (ISH+) by local laboratory assessment as per the most recent American Society of...
- Documented HR (ER and/or PR) positivity or negativity, confirmed by local laboratory assessment in a tumor sample obtained in the metastatic setting. ER and/or PR positivity is defined as \>1% of cells expressing HR via...
- No prior chemotherapy or HER2-targeted therapy for advanced or mBC (1 prior line of endocrine therapy is allowed for mBC). Participants who have received chemotherapy or HER2-targeted therapy in the neoadjuvant or...
- Evaluable disease as defined by RECIST v1.1. Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.
- Adequate FFPE tumor tissue sample available from the metastatic setting (preferably) for retrospective HER2 central analysis confirmed by central laboratory. An adequate sample of tumor tissue must be provided from...
- Patients with Brain Metastases (BM): Eligible if either previously untreated or previously treated BM, provided there is no clinical indication for immediate local therapy. For untreated BM, lesions must be ≤2.0 cm in...
- Adequate hematologic and end-organ function, defined by the following laboratory results (see protocol)
- LVEF ≥ 50% within 28 days before Cycle 1 Day 1.
- Life expectancy of ≥ 12 weeks at screening.
- Adequate treatment washout period before first dose of study intervention, defined as (see protocol)
- Male patients and female patients of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified highly effective method of contraception.
- Access to a smartphone with internet connection that allows them to carry out the required assessments at the specified timepoints and with the following characteristics:
- Resilience PRO: Android 8.0 (or newer) OR iOS 15.0 (or newer)
- Cankado PRO-React: Android 13.0 (or newer) OR iOS 17.0 (or newer)
- Only applicable in France: patients affiliated to the social security system.
What rules you out
- Patients with HER2-negative disease.
- people who, in the opinion of the investigator, are unable to comply with the protocol requirements or who have any comorbidity or condition that may hinder study follow-up, response evaluation, or the informed consent...
- History of other primary malignancy unless treated with curative intent with no evidence of active disease within 3 years before the first dose of study treatment and of low potential risk for recurrence. Exceptions...
- Persistent toxicities that the investigator deems related to previous anti-cancer therapy (excluding alopecia), not yet resolved to grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably...
- Untreated spinal cord compression
- History of significant cardiovascular disease, defined as:
- New York Heart Association Class III or greater congestive heart failure or known left ventricular ejection fraction of \< 50%.
- Participants with a medical history of myocardial infarction within 6 months before enrollment or symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above upper limit of normal (ULN) at screening...
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for...
- 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. Patients with a history of grade 1...
- Meets one of the following lung criteria:
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months of study enrollment, prior pneumonectomy (complete)...
- Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full...
- Received a live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study treatment. Note: Patients, if...
- Active serious infection requiring IV antibiotics, antivirals, or antifungals.
- Active HIV, HBV (defined as having a positive HbsAg test) or HCV.
- Participants with a known history of human immunodeficiency virus (HIV) are eligible, if viral load is undetectable for ≥ 6 months prior to enrollment, and people are receiving effective anti-retroviral HIV therapy, if...
- For patients with a known history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the...
- Patients who are HCV antibody positive with polymerase chain reaction negative for HCV RNA may be eligible
- Other concurrent medical or psychiatric conditions that, in the investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
- Received prior chemotherapy or HER2-targeted therapy for advanced or mBC.
- Prior exposure in the adjuvant setting to an antibody-drug conjugate containing an exatecan derivative (topoisomerase I inhibitor), with a disease-free interval of less than 12 months since the last dose
- Requirement for ongoing therapy with or prior use of any prohibited medications.
- Participation in other studies involving investigational drug(s) within 30 days prior to enrollment or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of...
- Known hypersensitivity or allergy to T-DXd, their metabolites, formulation excipient, or other monoclonal antibodies.
- Positive serum pregnancy test or women who are lactating.
- Only applicable in France: patients deprived of their liberty or under protective custody or guardianship.
The study team makes the final eligibility decision.
Where it's taking place
- Villejuif, France
- München, Germany
- Barcelona, Barcelona, Spain
- A Coruña, Spain
- Alicante, Spain
- Badajoz, Spain
- Barcelona, Spain
- Bilbao, Spain
- Girona, Spain
- Granada, Spain
- L'Hospitalet de Llobregat, Spain
- León, Spain
- Lleida, Spain
- Madrid, Spain
- Málaga, Spain
- Palma de Mallorca, Spain
- Reus, Spain
- Santa Cruz de Tenerife, Spain
- Santander, Spain
- Santiago de Compostela, Spain
+ 4 more site(s).
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Villejuif, France; München, Germany; Barcelona, Barcelona, Spain; A Coruña, Spain; Alicante, Spain; Badajoz, Spain and 18 more location(s). 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.