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

Breast Cancer Clinical Trial

— ADENDOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773004
• Other study ID #: UC-0140/1505 - ADENDOM
• Secondary ID: 2015-A00528-41PA
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: August 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• EPClin genomic test

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
UNICANCER	Myriad Genetics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result		15 days
Secondary	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.		1 year
Secondary	Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).		1 year