This trial is active, not recruiting.

Condition breast cancer
Sponsor NanoString Technologies, Inc.
Collaborator Institut Curie
Start date March 2015
End date December 2016
Trial size 200 participants
Trial identifier NCT02395575, PTL-10018


The primary objective of this study is to evaluate the impact of the result of the Prosigna Test (assay) on the therapeutic decision of adjuvant therapy (chemotherapy and hormone therapy) in patients suffering from early-stage breast cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test results.
time frame: 6 months

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0) - Estrogen receptor status will be evaluated by Immunohistochemistry (IHC) and more than 1% of stained tumor cells will be considered positive. - HER2 status will be evaluated by IHC (0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization. - Postmenopausal women defined as: - Natural Amenorrhea > 12 months, regardless of age - Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study) - Radiological castration with amenorrhea > 3 months, regardless of age - Hysterectomy and postmenopausal blood levels - Able to give consent - Eligible for treatment of breast cancer with adjuvant chemotherapy - ECOG performance status of 0 or 1 Exclusion Criteria: - Tumor size T3-T4 - Non-invasive breast cancer (e.g., Paget's disease, DCIS) - Tumors with nodes that are not N0, pN0 (i+), or pN0 (mol+) - Tumors that are estrogen-receptor negative or HER2 positive - Have metastatic disease - Unable to give informed consent - Unable to complete patient reported outcome surveys - Have contraindications for adjuvant chemotherapy - Age, performance status, significant comorbidities - ECOG performance status > 1

Additional Information

Official title Prospective Study Evaluating the Clinical Impact of the Breast Cancer Intrinsic Subtype-Prosigna Test (Assay) in the Management of Early-stage Breast Cancers
Principal investigator Roman Rouzier, MD, PhD
Description The secondary objectives will consist of: - The evaluation of the confidence in the therapeutic indications of the practitioners before and after the test (assay) results, and by subgroups of cancers - The evaluation of the rate of secondary effects of chemotherapy, - The evaluation of the emotional state of patients faced with the therapeutic decision, of their degree of anxiety and of their functional status before and after the Prosigna test (assay) results
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by NanoString Technologies, Inc..