Clinical trial · Interventional
Image-guided De-escalation of Neo-adjuvant Chemotherapy in HER2-positive Breast Cancer: the TRAIN-3 Study
NCT03820063CI-TRIAL-00095472TRAIN-3active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a multicenter, single arm, phase II study evaluating the efficacy of image-guided de-escalating neoadjuvant treatment with paclitaxel, Herceptin® (trastuzumab), carboplatin, and pertuzumab (PTC-Ptz) in stage II-Ill HER2-positive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PTC-Pz | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PTC-Pz
- description
- * Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8 * Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1 * Carboplatin AUC 6mg•ml/min administered intravenously on day 1 * Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg) * Treatment cycles are repeated on day 22 Patients who do not achieve pCR will complete a total of nine cycles taxane-containing chemotherapy followed by 14 cycles of treatment with adjuvant T-DM1.
- interventionNames
- Drug: PTC-Pz
Primary outcomes (1)
- measure
- Event free survival at three years
- timeFrame
- 3 years
- description
- Number of patients without progression of disease recurrence, second primary or death
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed primairy infiltrating breast cancer. 2. Stage II or Ill disease. 3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. 4. Age \<:18 5. ECOG Group performance status 6. LVEF \>50% measured by echocardiography, MRI or MUGA 7. Known HR-status ( in percentages) Exclusion Criteria: 1. Previous radiation therapy of chemotherapy 2. Pregnancy or breastfeeding 3. Evidence of distant metastases 4. Evidence of bilateral infiltrating breast cancer 5. Concurrent anti-cancer treatment or another investigational drug
References
Publications (2)
- DERIVEDLouis FM, van der Voort A, van Ramshorst MS, Daletzakis A, Mandjes IA, Kemper I, Agterof MJ, van der Steeg WA, Heijns JB, van Bekkum ML, Siemerink EJM, Kuijer PM, Scholten A, Wesseling J, Vrancken Peeters MTFD, Egeler MD, van de Poll-Franse LV, Mann RM, Sonke GS; Dutch Breast Cancer Research Group (BOOG). MRI-based personalisation of neoadjuvant chemotherapy duration in HER2-positive early breast cancer (TRAIN-3): primary results from a multicentre, single-arm, phase 2 study. Lancet Oncol. 2026 Mar;27(3):349-360. doi: 10.1016/S1470-2045(25)00707-7. Epub 2026 Feb 16. PMID 41713473
- DERIVEDvan der Voort A, Louis FM, van Ramshorst MS, Kessels R, Mandjes IA, Kemper I, Agterof MJ, van der Steeg WA, Heijns JB, van Bekkum ML, Siemerink EJ, Kuijer PM, Scholten A, Wesseling J, Vrancken Peeters MTFD, Mann RM, Sonke GS; Dutch Breast Cancer Research Group. MRI-guided optimisation of neoadjuvant chemotherapy duration in stage II-III HER2-positive breast cancer (TRAIN-3): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2024 May;25(5):603-613. doi: 10.1016/S1470-2045(24)00104-9. Epub 2024 Apr 5. PMID 38588682