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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)

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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

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 16, 2016
Last Update Posted Date October 22, 2019
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2016)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2016)
  • The evaluation of patient's quality of life (QoL), anxiety levels and satisfaction throughout before and after the test results using standardized "State-Trait-Anxiety Inventory" questionnaires. [ Time Frame: 1 year ]
  • Evaluation of the time needed by the centralized platform to perform the test. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Study Assessing EndoPredict® Genomic Test Impact on Shared Decision of Adjuvant Chemotherapy in Patients With ER-positive, Her2-negative Early Breast Cancer
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: EPClin genomic test
Study Arms  ICMJE 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.
Intervention: Other: EPClin genomic test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2016)
203
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02773004
Other Study ID Numbers  ICMJE 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 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Myriad Genetics, Inc.
Investigators  ICMJE
Study Chair: Frédérique Penault-Llorca, MD, PhD Centre Jean Perrin, Clermont Ferrand, France
Principal Investigator: Suzette Delaloge, MD Gustave Roussy, Villejuif, France
PRS Account UNICANCER
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP