N/A
N=580
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02535026 ↗Enrolled (actual)
580
Serious AEs
—
Results posted
Apr 2017
Primary outcome: Primary: 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 — 79.1; 19.8; 1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
79.1; 19.8; 1 | — |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer |
31.9; 35; 12.1; 20.9 | — |
| PRIMARY Percentage of Participants With Histological Sub-types of Breast Cancer |
78.3; 10.9; 3.6; 1.2; 1.2; 4.8 | — |
| PRIMARY Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups |
9.4; 6.4; 19.7; 21.8; 30.0; 24.4 | 0.280 |
| PRIMARY Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades |
0; 4.8; 30; 74; 70; 21.2 | <0.001 sig |
| PRIMARY Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion |
69.5; 60.1; 30.5; 39.9 | =0.03 sig |
| PRIMARY Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups |
5.9; 9.0; 15.9; 26.2; 30.7; 22.1 | =0.004 sig |
| PRIMARY Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades |
2.1; 2.1; 44.5; 72.8; 53.4; 23.1 | <0.001 sig |
| PRIMARY Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion |
67.9; 58.8; 32.1; 41.2 | =0.025 sig |
| PRIMARY Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups |
6.8; 9.6; 21.8; 18.3; 23.7; 36.5 | =0.056 |
| PRIMARY Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades |
3.9; 0; 62.5; 41.7; 33.6; 58.3 | <0.001 sig |
| PRIMARY Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion |
65.3; 57.4; 34.7; 42.6 | =0.129 |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups |
3.3; 10.4; 10; 6.7; 21.9; 21.9 | =0.003 sig |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades |
5.5; 4.0; 0; 0; 80.9; 65.2 | <0.001 sig |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion |
67; 56.7; 54.3; 75.8; 33; 43.3 | =0.001 sig |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status |
97.8; 96; 0; 0; 2.2; 4 | <0.001 sig |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status |
72.1; 76.6; 0; 0; 27.9; 23.4 | <0.001 sig |
| PRIMARY Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status |
0; 22.4; 100; 0; 100; 77.6 | <0.001 sig |
| PRIMARY Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries |
31.9; 35.0; 12.1; 20.9 | — |
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
Data sourced from ClinicalTrials.gov (NCT02535026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.