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NCT Number: NCT02773004

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPClin genomic test

Other

Primary outcomes

  1. The proportion of patients whose choice of treatment is changed as a result of receiving the EPclin genomic test result

    Time frame: 15 days

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Collaborators

  • Myriad Genetics, Inc.

Registry information

Official study 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

Acronym: ADENDOM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 16, 2016
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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