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Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer (ADENDOM)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773004
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

The trial population of this study is composed of women aged more than 18, who have developed a newly node-negative (or pN1mi), Estrogen Receptor (ER)-positive, Her2-negative invasive breast cancer with uncertainty on the indication of adjuvant chemotherapy using standard assessments.

Obtaining material for test is at no risk as done from the surgery material. Tumor molecular EndoPredict (EP)clin analysis will allow to obtain information on the expression of 8 breast cancer related genes and will provide important prognosis indications. Clinical validation studies have demonstrated that molecular assays are useful for stratifying patients into risk categories and helpful in making clinical treatment decisions in ER+/node-negative breast cancer patients.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: EPClin genomic test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Prospective Multicenter Study Assessing EndoPredict® (EP) Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer With Uncertainty on the Indication of Chemotherapy Using Standard Assessments
Actual Study Start Date : September 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
EndoPredict (EP)clin testing
Once the patient is registered, the most representative block of the primary tumor from surgery (or 10 paraffin slides) are sent to the central analysis platform for EP clin testing. The EPclin method is based on analysis of tumour genes in combination with the classical prognostic factors of nodal status and tumour size.
Other: EPClin genomic test



Primary Outcome Measures :
  1. The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Impact of genomic test results on patient's quality of life (QoL), anxiety levels and satisfaction results using standardized "State-Trait-Anxiety Inventory" questionnaires compared with general condition at baseline. [ Time Frame: 1 year ]
  2. Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results). [ Time Frame: 1 year ]


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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years,
  • Performance status 0 or 1,
  • Patient with newly diagnosed, previously untreated, unilateral, localized, histologically confirmed, invasive breast cancer
  • Fully operated breast cancer including complete resection of breast tumor and adequate axillary surgery
  • Available surgical material (formalin-fixed, paraffin-embedded) for EPclin® evaluation
  • ER-positive by IHC (>10% cells stained or Allred Score≥4)
  • HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
  • Node-negative or pN1mi (through axillary lymph node examination using sentinel node biopsy or axillary clearance)
  • Uncertainty regarding the toxicity/benefit of adjuvant chemotherapy, outlined inthe following situations:

    • Lobular histology
    • Or grade II
    • Or grade III and pT < 2cm
  • Adequate renal, hepatic, cardiac and hematopoietic functions for a chemotherapy administration
  • Willingness and ability to comply with scheduled visits as well as with test results and chemotherapy decision according to the latest
  • Signed informed consent and Health insurance coverage

Exclusion Criteria:

  • Non operable, bilateral, locally advanced, T4 or metastatic breast cancer
  • Any lymph node involvement with the exception of pN0i+ or pN1mi
  • HER2 Overexpression
  • Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
  • Any previous systemic or locoregional treatment for the present breast cancer
  • Documented inherited predisposition with BRCA1/2 or TP53 mutation
  • Previous hormone replacement therapy (HRT) stopped less than 2 weeks before surgery
  • Previous treatment for the present breast cancer
  • Person unable to give informed consent

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): NCT02773004


Sponsors and Collaborators
UNICANCER
Myriad Genetics, Inc.
Investigators
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Study Chair: Frédérique Penault-Llorca, MD, PhD Centre Jean Perrin, Clermont Ferrand, France
Principal Investigator: Suzette Delaloge, MD Gustave Roussy, Villejuif, France
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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02773004    
Other Study ID Numbers: UC-0140/1505 - ADENDOM
2015-A00528-41 ( Registry Identifier: Id-RCB )
PACS14 ( Other Identifier: UNICANCER )
ADENDOM ( Other Identifier: UNICANCER )
UCBG 2-14 ( Other Identifier: UNICANCER )
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
Genomic test
Chemotherapy decision
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases