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

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

Tracking Information

• First Submitted Date: April 27, 2016
• First Posted Date: May 16, 2016
• Last Update Posted Date: October 22, 2019
• Actual Study Start Date: September 2016
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: 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: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Breast Cancer
• Intervention: Other: EPClin genomic test

Study Arms

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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 11, 2016): 203
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2017
• Actual Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: 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 )
• 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

• 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: UNICANCER
• Collaborators: Myriad Genetics, Inc.

Investigators

• 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