Clinical trial NCT02535026: An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
Official title: Epidemiological, Prospective and Observational Study on the HER2 Status in Breast Invasive Carcinomas Assessed by Immunohistochemistry (IHC) and Silver In-situ Hybridization (SISH) in a Sample of Latin-American Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-08-28
Enrollment: 580
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies when surgery is not possible.

Brief summary: This is a descriptive, prospective, observational and epidemiological study on participants recently diagnosed with breast cancer to evaluate the HER2 status by IHC and SISH procedures.


Eligibility criteria: Inclusion Criteria:

- Anatomopathological samples (surgical specimens or when a surgical sample is not possible, a core needle biopsy may be used) from female participants with a histopathological diagnosis of invasive breast cancer

Exclusion Criteria:

* Samples whose residual material in the paraffin block(s) is insufficient for neoplasm representation in the procedures in this study
* Cancer samples that have received previous chemotherapy treatment

Primary outcomes:
measure: Percentage of Participants With Human Epidermal Growth Factor Receptor 2 (HER2) Status in Breast Cancer Specimens Using Immunohistochemistry (IHC) and Silver In-Situ Hybridization (SISH) Procedures
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Histological Sub-types of Breast Cancer
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
timeFrame: Baseline up to 30 months
measure: Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
timeFrame: Baseline up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lima
country: Peru
city: Lima
country: Peru
city: Lima
country: Peru
city: Montevideo
country: Uruguay
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: