Trial Outcomes & Findings for An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants (NCT NCT02535026)
NCT ID: NCT02535026
Last Updated: 2017-04-10
Results Overview
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
COMPLETED
580 participants
Baseline up to 30 months
2017-04-10
Participant Flow
Participant milestones
| Measure |
Breast Cancer (BC) Participants
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
|---|---|
|
Overall Study
STARTED
|
580
|
|
Overall Study
COMPLETED
|
580
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
Baseline characteristics by cohort
| Measure |
Breast Cancer Participants
n=580 Participants
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
580 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
HER2 status of the collected tissue samples was determined based on the results obtained from IHC test and SISH procedure. The IHC test gives a score of 0 to 3 positive (+) that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. If the score is 0 to 1+, it's called "HER2 negative (-)." If the score is 2+, it's called "borderline." A score of 3+ is called "HER2 positive." Tissue samples which had the IHC score of 2+ (borderline) were re-tested using SISH procedure for confirmation of the HER2 status. Tissue samples with SISH test results + were considered as HER2+. Tissue samples for which HER2 status was not determined were considered as HER2 equivocal.
Outcome measures
| Measure |
Breast Cancer Participants
n=580 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
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
HER2 negative
|
79.1 percentage of participants
|
—
|
—
|
—
|
|
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
HER2 positive
|
19.8 percentage of participants
|
—
|
—
|
—
|
|
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
HER2 equivocal
|
1 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype could be identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were estrogen receptor (ER) + and/or progesterone receptor (PR) +, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Histological grading was done by Nottingham Histologic Score system based on three factors, a) the amount of gland formation (differentiation), b) the nuclear features (pleomorphism) and c) the mitotic activity. Each of these features is scored from 1-3, and then each score is added to give a final total score ranging from 3-9. The final total score is used to determine the grade in the following way: i) Grade 1 tumors have a score of 3-5, ii) Grade 2 tumors have a score of 6-7, and iii) Grade 3 tumors have a score of 8-9.
Outcome measures
| Measure |
Breast Cancer Participants
n=574 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer
Luminal A
|
31.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer
Luminal B
|
35 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer
HER2 Enriched
|
12.1 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer
Triple Negative
|
20.9 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.
Outcome measures
| Measure |
Breast Cancer Participants
n=580 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Ductal carcinoma
|
78.3 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Lobular carcinoma
|
10.9 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Mucinous carcinoma
|
3.6 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Mixed carcinoma
|
1.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Metaplastic carcinoma
|
1.2 percentage of participants
|
—
|
—
|
—
|
|
Percentage of Participants With Histological Sub-types of Breast Cancer
Others
|
4.8 percentage of participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
Participants were categorized in to following age groups: a) less than (\<) 40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) greater than or equal to (≥) 70 years.
Outcome measures
| Measure |
Breast Cancer Participants
n=203 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=377 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
<40 years
|
9.4 percentage of participants
|
6.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
40-49 years
|
19.7 percentage of participants
|
21.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
50-59 years
|
30.0 percentage of participants
|
24.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
60-69 years
|
22.7 percentage of participants
|
24.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
≥70 years
|
18.2 percentage of participants
|
23.1 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Outcome measures
| Measure |
Breast Cancer Participants
n=203 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=377 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 1
|
0 percentage of participants
|
4.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 2
|
30 percentage of participants
|
74 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 3
|
70 percentage of participants
|
21.2 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Outcome measures
| Measure |
Breast Cancer Participants
n=203 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=376 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Present
|
69.5 percentage of participants
|
60.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Absent
|
30.5 percentage of participants
|
39.9 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Outcome measures
| Measure |
Breast Cancer Participants
n=290 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=290 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
60-69 years
|
26.6 percentage of participants
|
21.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
<40 years
|
5.9 percentage of participants
|
9.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
40-49 years
|
15.9 percentage of participants
|
26.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
50-59 years
|
30.7 percentage of participants
|
22.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
≥70 years
|
21.0 percentage of participants
|
21.7 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples from all participants who were willing to participate in the study.
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Outcome measures
| Measure |
Breast Cancer Participants
n=290 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=290 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 1
|
2.1 percentage of participants
|
2.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 2
|
44.5 percentage of participants
|
72.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 3
|
53.4 percentage of participants
|
23.1 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Outcome measures
| Measure |
Breast Cancer Participants
n=290 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=289 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Present
|
67.9 percentage of participants
|
58.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Absent
|
32.1 percentage of participants
|
41.2 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Outcome measures
| Measure |
Breast Cancer Participants
n=459 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=115 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
<40 years
|
6.8 percentage of participants
|
9.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
40-49 years
|
21.8 percentage of participants
|
18.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
50-59 years
|
23.7 percentage of participants
|
36.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
60-69 years
|
23.7 percentage of participants
|
24.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
≥70 years
|
24.0 percentage of participants
|
11.3 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Outcome measures
| Measure |
Breast Cancer Participants
n=459 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=115 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 1
|
3.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 2
|
62.5 percentage of participants
|
41.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Nuclear grade 3
|
33.6 percentage of participants
|
58.3 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.
Outcome measures
| Measure |
Breast Cancer Participants
n=458 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=115 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Present
|
65.3 percentage of participants
|
57.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Absent
|
34.7 percentage of participants
|
42.6 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Participants were categorized in to following age groups: a) \<40 years, b) 40-49 years, c) 50-59 years, d) 60-69 years, e) ≥70 years.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
<40 years
|
3.3 percentage of participants
|
10.4 percentage of participants
|
10 percentage of participants
|
6.7 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
40-49 years
|
21.9 percentage of participants
|
21.9 percentage of participants
|
18.6 percentage of participants
|
20 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
50-59 years
|
19.1 percentage of participants
|
28.9 percentage of participants
|
38.6 percentage of participants
|
25.8 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
60-69 years
|
25.1 percentage of participants
|
23.4 percentage of participants
|
20 percentage of participants
|
25 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
≥70 years
|
30.6 percentage of participants
|
15.4 percentage of participants
|
12.9 percentage of participants
|
22.5 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Nuclear pleomorphism was observed and graded accordingly. Grade 1: Nuclei small with little increase in size in comparison with normal breast epithelial cells, regular outlines, uniform nuclear chromatin, little variation in size; Grade 2: Cells larger than normal with open vesicular nuclei, visible nucleoli, and moderate variability in both size and shape; Grade 3: Vesicular nuclei, often with prominent nucleoli, exhibiting marked variation in size and shape, occasionally with very large and bizarre forms.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Nuclear grade 1
|
5.5 percentage of participants
|
4.0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Nuclear grade 2
|
80.9 percentage of participants
|
65.2 percentage of participants
|
25.7 percentage of participants
|
31.7 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Nuclear grade 3
|
13.7 percentage of participants
|
30.8 percentage of participants
|
74.3 percentage of participants
|
68.3 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included breast cancer tissue samples of all participants who were evaluable for this outcome measure.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2. Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Outcome measures
| Measure |
Breast Cancer Participants
n=182 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
Present
|
67 percentage of participants
|
56.7 percentage of participants
|
54.3 percentage of participants
|
75.8 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
Absent
|
33 percentage of participants
|
43.3 percentage of participants
|
45.7 percentage of participants
|
24.2 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
ER Status: Positive
|
97.8 percentage of participants
|
96 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
ER Status: Negative
|
2.2 percentage of participants
|
4 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
PR Status: Positive
|
72.1 percentage of participants
|
76.6 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
PR Status: Negative
|
27.9 percentage of participants
|
23.4 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
HER2 Status: Positive
|
0 percentage of participants
|
22.4 percentage of participants
|
100 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
HER2 Status: Negative
|
100 percentage of participants
|
77.6 percentage of participants
|
0 percentage of participants
|
100 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline up to 30 monthsPopulation: Included all breast cancer tissue samples for which the phenotype was identified.
Breast cancer phenotypes were classified in to a) Luminal A: tissue samples that were ER+ and/or PR+, HER2-, and either histologic grade 1 or 2; b) Luminal B: tissue samples that were ER+ and/or PR+ and HER2+ or ER+ and/or PR+ and HER2- and histologic grade 3; c) HER2 enriched: tissue samples that were ER-, PR-, and HER2+; d) Triple negative: tissue samples that were negative for ER, PR, and HER2.
Outcome measures
| Measure |
Breast Cancer Participants
n=183 Number of Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
|
Breast Cancer Participants (ER+)
n=201 Number of Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
|
BC Participants-HER2 Enriched Phenotype
n=70 Number of Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
|
BC Participants-Triple Negative Phenotype
n=120 Number of Tissue samples
Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
|
|---|---|---|---|---|
|
Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
|
31.9 percentage of participants
|
35.0 percentage of participants
|
12.1 percentage of participants
|
20.9 percentage of participants
|
Adverse Events
Breast Cancer Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER