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Compares treatment options for HER2-positive Early Breast Cancer
Official title NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer
ClinicalTrials.gov ID: NCT05704829
What this study is testing
What is Trastuzumab deruxtecan?
Trastuzumab deruxtecan is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for her2-positive early 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
- ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC.
- 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
- Patients eligible for inclusion in this study must meet all the following criteria: 1\. Female patients with invasive, untreated HER2+ breast cancer...
- absolute neutrophil count ≥ 1.5 × 109/L,
- platelets ≥ 100 × 109/L,
- haemoglobin ≥ 9.0 g/dL:
- estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,
You likely can't join if
- Patients eligible for inclusion in this study must not meet any of the following criteria:
- 1\. Non-operable breast cancer including inflammatory breast cancer
- cT1a/b, cN0 breast cancer
- Any previous history of invasive breast cancer
- Primary malignancies within 5 years, with the exception of
- adequately resected non-melanoma skin cancer
See the full eligibility criteria
- Patients eligible for inclusion in this study must meet all the following criteria: 1\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration...
- absolute neutrophil count ≥ 1.5 × 109/L,
- platelets ≥ 100 × 109/L,
- haemoglobin ≥ 9.0 g/dL:
- estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by a Cockcroft-Gault formula,
- INR ≤ 1.5,
- serum creatinine \< 1.5 mg/dL,
- total bilirubin \< ULN, except for patients with Gilbert's Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN,
- aspartate transaminase (AST) \< 2.5 × ULN,
- alanine transaminase (ALT) \< 2.5 × ULN. 8. Adequate treatment washout period before randomisation (refer to protocol for detailed information) 9. Evidence of post-menopausal status or negative serum pregnancy test for...
- had underwent bilateral oophorectomy, or
- are ≥ 60 years of age, or
- are \< 60 years of age and amenorrhoeic for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression)
- and/or whose FSH- and oestradiol-blood values are within the postmenopausal range per local laboratory normal range. 10\. Female people must not donate, or retrieve for their own use, ova from the time of randomisation...
- Patients eligible for inclusion in this study must not meet any of the following criteria:
- 1\. Non-operable breast cancer including inflammatory breast cancer
- cT1a/b, cN0 breast cancer
- Any previous history of invasive breast cancer
- Primary malignancies within 5 years, with the exception of
- adequately resected non-melanoma skin cancer
- curatively treated in-situ disease
- Any evidence for existing metastatic disease (confirmed by CT Thorax/Abdomen, bone scan, or other methods according to clinical practice
- Previous or concurrent treatment with cytotoxic agents for any reason (except non-oncological reasons)
- Concurrent treatment with other experimental drugs and participation in another clinical trial with any investigational drug within 30 days prior to study entry
- Severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study/inadequate organ function
- Reasons indicating risk of poor compliance
- Woman of child-bearing potential defined as a woman physiologically capable of becoming pregnant, and not using highly effective methods of contraception during the study treatment and for 7 months after stopping the...
- Use of oral (oestrogen and progesterone), transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy.
- Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the...
- Patients with a medical history of myocardial infarction (MI) within 6 months before randomisation, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), people with troponin levels...
- Corrected QT interval (QTcF) prolongation to \> 470 msec (females) based on average of the screening 12-lead ECG.
- 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 criteria:
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder
- Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of randomisation.
- Prior pneumonectomy (complete)
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction...
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of trastuzumab deruxtecan or carboplatin. Note...
- Known allergy or hypersensitivity to study treatment (T-DXd), to comparator (SoC-) treatment, or any of the study drug / comparator (SoC-) excipients.
- History of severe hypersensitivity reactions to other monoclonal antibodies.
- Pregnant or breastfeeding female patients, or patients who are planning to become pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Baden-Baden, Baden-Wurttemberg, Germany
- Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Tübingen, Baden-Wurttemberg, Germany
- Ulm, Baden-Wurttemberg, Germany
- Augsburg, Bavaria, Germany
- Munich, Bavaria, Germany
- Bremerhaven, Free Hanseatic City of Bremen, Germany
- Frankfurt am Main, Hesse, Germany
- Kassel, Hesse, Germany
- Braunschweig, Lower Saxony, Germany
- Georgsmarienhütte, Lower Saxony, Germany
- Hildesheim, Lower Saxony, Germany
- Stade, Lower Saxony, Germany
- Rostock, Mecklenburg-Vorpommerns, Germany
- Aachen, North Rhine-Westphalia, Germany
- Bielefeld, North Rhine-Westphalia, Germany
- Cologne, North Rhine-Westphalia, Germany
- Düsseldorf, North Rhine-Westphalia, Germany
- Eschweiler, North Rhine-Westphalia, Germany
- Essen, North Rhine-Westphalia, Germany
+ 16 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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baden-Baden, Baden-Wurttemberg, Germany; Freiburg im Breisgau, Baden-Wurttemberg, Germany; Tübingen, Baden-Wurttemberg, Germany; Ulm, Baden-Wurttemberg, Germany; Augsburg, Bavaria, Germany; Munich, Bavaria, Germany and 30 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.