Clinical trial NCT01899079: A Prospective Observational Study of Clinical Outcomes for the NanoString® Technologies Prosigna Gene Signature Assay
Official title: Prospective Observational Study to Evaluate the Impact of the Determination of the Intrinsic Subtypes of Breast Cancer by PAM50 NanoString Technology in the Use of Adjuvant Chemotherapy in Women With Breast Cancer, HR+ and Node -.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Prosigna
FFPE
node negative
estrogen receptor positive
HER2 negative
Lead sponsor: NanoString Technologies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cedar Associates LLC
name: Illumina, Inc.
name: Grupo Espanol de Investigacion del Cancer de Mama
name: Spanish Breast Cancer Research Group
name: Hospital General Universitario Gregorio Marañon
name: Vall d'Hebron Institute of Oncology
First posted: 2013-07-15
Enrollment: 217
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with node-negative, estrogen-receptor positive, HER2-negative early-stage breast cancer. Investigators will offer enrollment to consecutively seen women who meet the entry criteria.

Brief summary: The primary objective of this study is to assess the extent to which the Prosigna™ Breast Cancer Prognostic Gene Signature Assay affects the medical oncologist's treatment recommendations regarding adjuvant chemotherapy and actual treatments received for patients with early-stage breast cancer.

Detailed description: Changes in treatment recommendations will include (1) hormonal therapy alone, (2) hormonal therapy plus chemotherapy, and (3) changes in types of chemotherapy if chemotherapy was recommended before and after the Prosigna test.

Eligibility criteria: Inclusion Criteria:

* Resected node-negative, estrogen-receptor-positive, HER2-negative early- stage invasive breast cancer (T1-T2, N0, pN0 (i+), pN0 (mol+), M0)

  1. Estrogen receptor status will be evaluated by Immunohistochemistry (IHC)and more than 1% of stained tumor cells will be considered positive.
  2. HER2 status will be evaluated by (IHC; 0 or 1+, or 2+ will be considered negative) and by in-situ fluorescence hybridization.
* Postmenopausal females, which is defined as:

  1. Natural Amenorrhea \> 12 months, regardless of age
  2. Bilateral oophorectomy, regardless of age (the oophorectomy must have been carried out at least 4 weeks before entering the study)
  3. Radiological castration with amenorrhea \> 3 months, regardless of age
  4. 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

Primary outcomes:
measure: The proportion of patients whose choice of treatment is changed as a result of receiving the Prosigna test result
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Consorci Sanitari de Terrassa
city: Barcelona
country: Spain
facility: Corporacio Sanitaria Parc Tauli
city: Barcelona
country: Spain
facility: Hospital U. Vall D'Hebron
city: Lleida
country: Spain
facility: Hospital U. Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital G.U. Gregorio Maranon
city: Madrid
country: Spain
facility: Hospital Quirón Madrid
city: Madrid
country: Spain
facility: Hospital U. 12 de Octubre
Study officials:
affiliation: Hospital General Universitario Gregorio Marañón
name: Miguel Martin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: