Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer

NCT03904173 | Active Not Recruiting

• 1 other identifier: Protocol EMIT-1
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 5

Brief Summary

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

Breast Cancer; Breast Neoplasms; Hormone Receptor Positive Tumor

Keywords

human epidermal growth factor receptor 2 positive; human epidermal growth factor receptor 2 negative

Outcome Measures

Primary Outcomes (2)

• Treatment decision differences with or without Prosigna test

  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).

  3 years

• Distant recurrence-free interval

  Patients receiving no adjuvant chemotherapy based on Prosigna test results in combination with routine clinicopathological variables, will be recorded for metastatic events during the follow up period. To identify factors associated with survival, methods to be applied include Kaplan-Meier plots and Cox regression analyses. To statistically assess the association between breast cancer subgroups found in the analysis described above and clinical endpoints, statistical tests for comparison of survival in two or more groups (log rank test) will be used. Multivariate regression analysis will be used to adjust for other factors (such as age). Possible violations of the proportional hazards assumption inherent in both types of tests above will be detected using graphical methods as well as formal tests based on the Schoenfeld residuals.

  8 years from study start

Secondary Outcomes (1)

• Recurrence-free interval

  8 years from study start

Other Outcomes (3)

• Patient reported outcome - EQ-5D

  3 months, 6 months, 1 year, 2 years and 5 years

• Patient reported outcome - FACT-B/ES

  3 months, 6 months, 1 year, 2 years and 5 years

• Health care costs for the hospitals and society using the Prosigna test

  5 years

Study Arms (1)

EMIT-1 - Multi-parameter tests

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.

Diagnostic Test: Multi-parameter tests

Interventions

Multi-parameter tests DIAGNOSTIC_TEST

Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) risk of recurrence (ROR) analysis CE marked assay termed Prosigna™ using digital bar code technology (NanoString Technologies Inc.).

EMIT-1 - Multi-parameter tests

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary non-metastatic, node negative (pN0), hormone receptor positive, HER2 negative breast cancer. Patients with pT1pN1(mi) status may also be included.

You may qualify if:

• Written informed consent (informed consent document approved by the Independent Ethics Committee \[IEC\]) obtained prior to any study-specific procedure
• Female or male age ≥ 18 years
• Able to comply with the protocol
• Primary surgery completed or if re-resection needed, a change from pT1 to pT2 categorization is not expected
• 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)
• Primary tumor concluded as hormone receptor positive (ER ≥ 1%), HER2 negative.

You may not qualify if:

• Metastasis to regional lymph nodes or distant sites/organs.
• Previous treatment for localized breast cancer. Previous treatment for DCIS is allowed.
• HER2 positive
• ER and PgR negative tumor (\< 1% expression)
• 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
• 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).
• Evidence of any other disease or condition that by the investigator is considered to impede follow-up of the patients.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Klinbeforsk: collaborator
• Norwegian Cancer Society: collaborator

Study Sites (5)

Haukeland University Hospital

Bergen, Bergen, 5021, Norway

Location

Drammen Hospital - Vestre Viken

Drammen, Buskerud, 3004, Norway

Location

Østfold Hospital

Sarpsborg, Kalnes, 1714, Norway

Location

Oslo University Hospital

Oslo, Oslo County, 0424, Norway

Location

Telemark Hospital

Skien, Ulefossveien 55, 3710, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

fixed tissue, plasma, peripheral blood.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bjørn Naume, MD PhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National coordinating investigator

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: April 5, 2019
• Study Start: October 29, 2018
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2043
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

NO (5)