Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03904173
Recruitment Status : Recruiting
First Posted : April 5, 2019
Last Update Posted : March 8, 2021
Sponsor:
Collaborators:
Klinbeforsk
Norwegian Cancer Society
Information provided by (Responsible Party):
Bjørn Naume, Oslo University Hospital

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.

Condition or disease Intervention/treatment
Breast Cancer Breast Neoplasms Hormone Receptor Positive Tumor Diagnostic Test: Multi-parameter tests

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 2150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishment of Molecular Profiling for Individual Clinical Routine Treatment Decision in Early Breast Cancer
Actual Study Start Date : October 29, 2018
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : December 31, 2043

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
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
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.).




Primary Outcome Measures :
  1. Treatment decision differences with or without Prosigna test [ Time Frame: 3 years ]
    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).

  2. Distant disease free survival [ Time Frame: 8 years from study start ]
    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.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 8 years from study start ]
    Patients receiving no adjuvant chemotherapy based on Prosigna test results in combination with routine clinicopathological variables, will be recorded breast cancer recurrence 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.


Other Outcome Measures:
  1. Patient reported outcome - EQ-5D [ Time Frame: 3 months, 6 months, 1 year, 2 years and 5 years ]
    Measured by the EQ-5D questionnaire

  2. Patient reported outcome - FACT-B/ES [ Time Frame: 3 months, 6 months, 1 year, 2 years and 5 years ]
    Measured by FACT-B and FACT-ES questionnaire

  3. Health care costs for the hospitals and society using the Prosigna test [ Time Frame: 5 years ]
    To establish the cost-effectiveness (i.e. health resource use in hospitals and society) of test-directed (Prosigna) treatment strategy compared to standard practice.Formal economic evaluation of cost-benefit will be performed based on simulation of treatment paths. Firstly, an analysis of the expected cost of the interventions (patient and hospital costs) will be performed. The second step will involve an estimation of the benefits. The size of the benefits will be estimated from data provided by the clinical study as well as from other external sources. Finally, the information on costs and benefits will be used in a formal model that simulates the various treatment paths a patient can take (with the associated probabilities, costs and benefits). These simulations will lead to conclusion about the cost per quality adjusted life of the new procedures compared to the current system as well as more general social gains (including benefits such as reduced sick pay).


Biospecimen Retention:   Samples Without DNA
fixed tissue, plasma, peripheral blood.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03904173


Contacts
Layout table for location contacts
Contact: Bjørn Naume, MD PhD +4722934732 bjorn.naume@medisin.uio.no
Contact: Hege Oma Ohnstad, MD PhD +4723026600 HEGEO@ous-hf.no

Locations
Layout table for location information
Norway
Drammen Hospital - Vestre Viken Recruiting
Drammen, Buskerud, Norway, 3004
Contact: Helle Kristine Skjerven, M.D.-Ph.D.       Helle.skjerven@vestreviken.no   
Principal Investigator: Helle Kristine Skjerven, M.D.-Ph.D.         
Østfold Hospital Recruiting
Sarpsborg, Kalnes, Norway, 1714
Contact: Andreas Stensvold, MD, PhD    +4799290151    andreas.stensvold@so-hf.no   
Contact: Silje Songe-Møller, MD    +4799640344    Silje.Songe-Moller@so-hf.no   
Principal Investigator: Andreas Stensvold, MD, PhD         
Telemark Hospital Not yet recruiting
Skien, Ulefossveien 55, Norway, 3710
Contact: Tor Jensen, M.D.-Ph.d.       torje@sthf.no   
Principal Investigator: Tor Jensen, M.D.-Ph.d.         
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Hans P Eikesdal, M.D.-Ph.D.       hans.eikesdal@uib.no   
Principal Investigator: Hans P Eikesdal, M.D.-Ph.D.         
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Hege Oma Ohnstad, MD PhD    +4741427483    HEGEO@ous-hf.no   
Contact: Bjørn Naume, MD PhD    +4722934732    bjorn.naume@medisin.uio.no   
Principal Investigator: Hege Oma Ohnstad, MD PhD         
Sponsors and Collaborators
Oslo University Hospital
Klinbeforsk
Norwegian Cancer Society
Investigators
Layout table for investigator information
Study Director: Bjørn Naume, MD PhD Oslo University Hospital
Layout table for additonal information
Responsible Party: Bjørn Naume, National coordinating investigator, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03904173    
Other Study ID Numbers: Protocol EMIT-1
First Posted: April 5, 2019    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bjørn Naume, Oslo University Hospital:
human epidermal growth factor receptor 2 positive
human epidermal growth factor receptor 2 negative
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases