Clinical trial · Observational
Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer
- 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)
The present project focuses on how to reduce both over- and under-treatment with adjuvant chemotherapy to a large number of breast cancer patients in Norway. A set of primary tumor prognostic factors can be analysed for potential achievement of this. Furthermore, multi-parameter tests, including detailed molecular analysis of the primary tumors might further improve the selection of patients among the lymph node negative. The study seeks to advance the development of personalised treatment of patients with early breast cancer without lymph node metastasis, by the evaluation of multi-parameter analysis as a means of identifying those patients who are likely to benefit from chemotherapy whilst sparing those who are unlikely to do so from an unnecessary and unpleasant treatment.
Conditions
Conditions (3)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Hormone Receptor Positive Tumor | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multi-parameter tests | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EMIT-1 - Multi-parameter tests
- description
- Patients with hormone sensitive HER2 negative primary breast cancer without lymph node metastasis. Treatment recommendations will be based on the Prosigna test result, in addition to conventional clinicopathological parameters.
- interventionNames
- Diagnostic Test: Multi-parameter tests
Primary outcomes (2)
- measure
- Treatment decision differences with or without Prosigna test
- timeFrame
- 3 years
- description
- Differences in the number of patients receiving the various adjuvant treatments using Prosigna-test (in addition to the routine clinicopathological variables) as basis for treatment decisions compared to standard adjuvant treatment recommendations (based on clinicopathological variables only).
- measure
- Distant recurrence-free interval
- timeFrame
- 8 years from study start
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written informed consent (informed consent document approved by the Independent Ethics Committee \[IEC\]) obtained prior to any study-specific procedure 2. Female or male age ≥ 18 years 3. Able to comply with the protocol 4. Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected 5. Histologically confirmed adenocarcinoma of the breast ≤ 5.0 cm in size (pT1-2) without metastasis to regional lymph nodes (pN0) or ≤ 20 mm in size (pT1) with lymph node micrometastases only (pN1mi) 6. Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative. Exclusion Criteria: 1. Metastasis to regional lymph nodes or distant sites/organs. 2. Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed. 3. HER2 positive 4. ER and PgR negative tumor (\< 1% expression) 5. Other concomitant or earlier carcinoma less than five years prior to the breast cancer diagnosis, except for basal cell carcinoma and in situ cervix cancer 6. Use of or participation in intervention trials testing treatment with any investigational anti-cancer drug. Participation in other types of intervention trials is allowed (such participation needs to be registered). 7. Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.
References
Publications (0)
Data not yet available