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Clinical trial comparing Trastuzumab Deruxtecan with Trastuzumab Emtansine in high-risk HER2-positive patients with residual breast cancer following neoadjuvant therapy
EU CTIS ID: 2023-507961-24-00
What this study is testing
To evaluate IDFS with T-DXd treatment as compared to T-DM1
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Sign and date the tissue screening and main ICFs, prior to the start of any study-specific qualification procedures.
- Known hormone receptor status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR-positive status defined by either positive estrogen receptor (ER) or positive progesterone receptor (PR) status. HR-negative status defined by both known negative ER and known negative PR.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function within 14 days before randomization as defined in the protocol.
- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months for males and 7 months for females after the last dose of study drug. See protocol for full details
You likely can't join if
- Stage IV (metastatic) breast cancer.
- Any autoimmune, connective tissue or inflammatory disorders (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc...) where there is documented, or a suspicion of pulmonary involvement, or pneumonectomy at the time of screening
- Uncontrolled or significant cardiovascular disease, including: Medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization.
- Has a corrected QT interval per Fridericia's formula (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on screening 12-lead electrocardiogram (ECG).
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
- History of severe hypersensitivity reactions to other monoclonal antibodies (MAb).
See the full eligibility criteria
Who can join
- Sign and date the tissue screening and main ICFs, prior to the start of any study-specific qualification procedures.
- Known hormone receptor status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR-positive status defined by either positive estrogen receptor (ER) or positive progesterone receptor (PR) status. HR-negative status defined by both known negative ER and known negative PR.
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has adequate organ function within 14 days before randomization as defined in the protocol.
- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4 months for males and 7 months for females after the last dose of study drug. See protocol for full details
- Male subjects must not freeze or donate sperm starting at randomization and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrolment in this study.
- Female subjects must not donate, or retrieve for their own use, ova from the time of randomization and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to randomization in this study.
- Adults ≥18 y old. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 y old).
- HER2-positive breast cancer, meeting all of the criteria listed in the protocol (see protocol for full details).
- Histologically confirmed invasive breast carcinoma at time of disease presentation. Subjects with inflammatory breast cancer are allowed provided all eligibility criteria are met.
- Clinical stage at disease presentation of T1-4, N0-3, M0 prior to neoadjuvant therapy (Note: Patients presenting with T1N0 tumors will not be eligible).
- Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the high risk criteria described in detail in the protocol.
- Completion of neoadjuvant systemic therapy, including taxane-based chemotherapy and HER2-directed treatment prior to surgery
- Adequate excision as confirmed per medical records: surgical removal of all clinically evident disease in the breast and axillary lymph nodes (see Section 8.1.2).
- An interval of no more than 12 weeks between the date of last surgery and the date of randomization.
What rules you out
- Stage IV (metastatic) breast cancer.
- Any autoimmune, connective tissue or inflammatory disorders (eg, Rheumatoid arthritis, Sjogren's, sarcoidosis, etc...) where there is documented, or a suspicion of pulmonary involvement, or pneumonectomy at the time of screening
- Uncontrolled or significant cardiovascular disease, including: Medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization.
- Has a corrected QT interval per Fridericia's formula (QTcF) prolongation to > 470 msec (females) or > 450 msec (males) based on screening 12-lead electrocardiogram (ECG).
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
- History of severe hypersensitivity reactions to other monoclonal antibodies (MAb).
- Inadequate washout period before Randomization/Cycle 1 Day 1, as defined in the protocol.
- Substance abuse or 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 clinical study or evaluation of the clinical study results.
- Social, familial, or geographical factors that would interfere with study participation or follow-up.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection.
- History of any prior (ipsi- or contralateral) breast cancer except lobular carcinoma in situ (LCIS).
- Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.
- Is pregnant or breastfeeding or planning to become pregnant.
- Has history of receiving live, attenuated vaccine (mRNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention
- Evidence of clinically evident gross residual or recurrent disease following neoadjuvant therapy and surgery (see Section 8.1.2.1).
- An overall response of progressive disease according to the investigator at the conclusion of preoperative systemic therapy
- Prior treatment with T-DXd, T-DM1 or other anti-HER2 ADC or prior enrollment in any clinical trial with T-DXd (regardless of treatment arm).
- History of exposure to the following cumulative doses of anthracyclines (see protocol for full details).
- History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ (CIS) of the cervix, nonmelanoma skin carcinoma, Stage I melanoma skin carcinoma, Stage I uterine cancer, or other appropriately treated non-breast malignancies with an outcome similar to those mentioned above.
- History of (noninfectious) ILD/pneumonitis that required steroids or has ILD/pneumonitis noted on computed tomography (CT) scan of the chest at Screening (asymptomatic interstitial changes confined to recent radiation therapy fields are not excluded).
- Known pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within three months prior to randomization, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, etc.).
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- China
- Mexico
- Singapore
- Russian Federation
- Japan
- Israel
- Argentina
- United States
- Hong Kong
- Australia
- Korea, Republic of
- Peru
- Chile
- United Kingdom
- Brazil
- Canada
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taiwan; China; Mexico; Singapore; Russian Federation; Japan and 11 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 EU CTIS; the study team decides eligibility.