Clinical trial · Interventional
MINT I Multi- Institutional Neo-adjuvant Therapy MammaPrint Project I
NCT01501487CI-TRIAL-00033514MINTcompletedPhase 4ClinicalTrials.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)
Genomics assays that measure specific gene expression patterns in a patient's primary tumor have become important prognostic tools for breast cancer patients. This study is designed to test the ability of MammaPrint® in combination with TargetPrint®, BluePrint®, and TheraPrint®, as well as traditional pathologic and clinical prognostic factors, to predict responsiveness to neo-adjuvant chemotherapy in patients with locally advanced breast cancer (LABC).
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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose dense AC followed by T + trastuzumab | Drug | — | UNRESOLVED |
| Dose dense AC followed by T + trastuzumab + pertuzumab | Drug | — | UNRESOLVED |
| Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy | Drug | — | UNRESOLVED |
| PTH followed by dose dense AC of FEC | Drug | — | UNRESOLVED |
| TAC chemotherapy | Drug | — | UNRESOLVED |
| TC chemotherapy | Drug | — | UNRESOLVED |
| TCH chemotherapy | Drug | — | UNRESOLVED |
| T + trastuzumab followed by CEF + trastuzumab | Drug | — |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- HER2 negative patients
- description
- In order to provide some consistency in management and have a treatment policy in place only recommended therapy with several well accepted and presumed equivalent chemotherapy regimens will be used. The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients include: 1. TAC chemotherapy 2. TC chemotherapy 3. Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
- interventionNames
- Drug: TAC chemotherapy
- Drug: TC chemotherapy
- Drug: Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Her2 positive patients
- description
- The proposed neo-adjuvant chemotherapy regimens for HER2 negative patients is TCH chemotherapy.
- interventionNames
- Drug: TCH chemotherapy
- Drug: T + trastuzumab followed by CEF + trastuzumab
- Drug: Dose dense AC followed by T + trastuzumab
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically proven invasive breast cancer and no distant metastases and; * Lymphnode negative and a clinical tumor classification of T2 (≥3.5cm)-T4 or with 1-3 positive lymph nodes and a clinical tumor classification of T2-T4 DCIS or LCIS are allowed in addition to invasive cancer at T2 or T3 level. * Age ≥ 18 years. * At least one lesion that can be accurately measured in two dimensions utilizing mammogram, ultrasound, or MRI images to define specific size and validate complete pathologic response. * Adequate bone marrow reserves (neutrophil count \>1.5 x109 /l and platelet count \>100 x109/l), adequate renal function (serum creatinine ≤ 1.5 x upper limit of normal) and hepatic function (ALAT, ASAT ≤ 2.5 x upper limit of normal, alkaline phosphatase ≤ 2.5 x upper limit of normal and total bilirubin ≤ 2.0 x upper limit of normal). * Signed informed consent of the patient Exclusion Criteria: * Any patient with confirmed metastatic disease. Patients with inflammatory breast cancer. * Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails Quality Assurance or Quality Control criteria. * Patients who have had any prior chemotherapy, radiotherapy, or endocrine therapy for the treatment of breast cancer. * Any serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease.
References
Publications (0)
Data not yet available
No reference posted for this study.