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

Unicancer

Status: Completed

Conditions: Breast Cancer

Treatments: Other: EPClin genomic test

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02773004

UCBG 2-14 (Other Identifier)

2015-A00528-41 (Registry Identifier)

ADENDOM (Other Identifier)

PACS14 (Other Identifier)

UC-0140/1505 - ADENDOM

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

EndoPredict (EP)clin testing

Other group

Description:

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.

Treatment:

Other: EPClin genomic test