BridgeMD
Neoadjuvant trastuzumab, pertuzumab and tucatinib without chemotherapy in HER2-positive breast cancer: the TRAIN-4 study
EU CTIS ID: 2024-518192-61-00
What this study is testing
To evaluate safety and feasibility of a neoadjuvant chemotherapy-free regimen with trastuzumab plus pertuzumab plus tucatinib in stage II-III HER2-positive breast cancer.
- Phase I and Phase II (Integrated)- Other
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
- Signed written informed consent
- Laboratory requirements within 21 days prior to enrollment: a. Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l); b. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists; c. Adequate renal function: creatinine clearance >50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement
- Histologically confirmed primary invasive breast cancer
- Stage II – IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
- HER2 overexpression defined as circumferential membrane staining that is complete, intense and in >10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
- Known estrogen- and progesterone-receptor expression of the invasive tumor a. ER-negative or PR-negative is defined as <10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR
You likely can't join if
- Inflammatory breast cancer, cT4 and/or cN3 tumors
- Contraindications for MRI
- Occult breast cancer (cT0)
- Bilateral breast cancer
- Current pregnancy or breastfeeding
- Current or previous other malignancy unless treated without systemic therapy and more than five years ago
See the full eligibility criteria
- Signed written informed consent
- Laboratory requirements within 21 days prior to enrollment: a. Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l); b. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists; c. Adequate renal function: creatinine clearance >50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement
- Histologically confirmed primary invasive breast cancer
- Stage II – IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
- HER2 overexpression defined as circumferential membrane staining that is complete, intense and in >10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
- Known estrogen- and progesterone-receptor expression of the invasive tumor a. ER-negative or PR-negative is defined as <10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR
- WHO performance status 0-1
- Age (≥ 18 years of age)
- LVEF ≥50% measured by echocardiography or MUGA
- Eligible for neoadjuvant treatment
- Inflammatory breast cancer, cT4 and/or cN3 tumors
- Contraindications for MRI
- Occult breast cancer (cT0)
- Bilateral breast cancer
- Current pregnancy or breastfeeding
- Current or previous other malignancy unless treated without systemic therapy and more than five years ago
- Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to first dose of study treatment
- Known chronic liver disease
- History of inflammatory bowel disease or bowel resection
The study team makes the final eligibility decision.
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.
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.