Clinical trial NCT02773004: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Genomic test
Chemotherapy decision
Lead sponsor: UNICANCER
Sponsor class: OTHER
Collaborators: name: Myriad Genetics, Inc.
First posted: 2016-05-16
Enrollment: 203
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result
timeFrame: 15 days
Secondary outcomes:
measure: 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.
timeFrame: 1 year
measure: Time required by the centralized platform to perform the test (calculated from the biological sample receipt to the genomic test results).
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Centre Jean Perrin, Clermont Ferrand, France
name: Frédérique Penault-Llorca, MD, PhD
role: STUDY_CHAIR
affiliation: Gustave Roussy, Villejuif, France
name: Suzette Delaloge, MD
role: PRINCIPAL_INVESTIGATOR
References: