Breast CancerNCT02535026
An Observational Study on Human Epidermal Growth Factor Receptor (HER) 2 Status of Breast Invasive Carcinoma in Latin American Participants
An observational study of Breast Cancer, run by Hoffmann-La Roche at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 580 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
About this study
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
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.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Participants | Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies will be considered for analysis in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer
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.
Measured: Baseline up to 30 months
Percentage of Participants With Histological Sub-types of Breast Cancer
Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.
Measured: Baseline up to 30 months
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
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.
Measured: Baseline up to 30 months
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
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.
Measured: Baseline up to 30 months
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Measured: Baseline up to 30 months
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
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.
Measured: Baseline up to 30 months
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
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.
Measured: Baseline up to 30 months
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Measured: Baseline up to 30 months
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
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.
Measured: Baseline up to 30 months
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
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.
Measured: Baseline up to 30 months
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
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.
Measured: Baseline up to 30 months
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
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.
Measured: Baseline up to 30 months
Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
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.
Measured: Baseline up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startJul 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 580 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535026
- Sponsor's protocol ID
- ML25371
- Status last verified
- Feb 2017
- First submitted
- 26 Aug 2015
- Last updated
- 10 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02535026
- Acronym / sponsor ID
- ML25371
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 10 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Participants | – | –Breast tissue samples from female participants with a breast cancer diagnosis that undergo an anatomopathological examination of surgical specimens and/or core needle biopsies will be considered for analysis in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Histological Sub-types of Breast Cancer
Time frame: Baseline up to 30 months
Histological subtypes of breast cancer included ductal carcinoma, lobular carcinoma, mucinous carcinoma, mixed carcinoma, metaplastic carcinoma, and others.
Percentage of Participants With ER Status (Positive or Negative) Across Different Age Groups
Time frame: Baseline up to 30 months
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.
Percentage of Participants With ER Status (Positive or Negative) Based on Nuclear Grades
Time frame: Baseline up to 30 months
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.
Percentage of Participants With ER Status (Positive or Negative) Based on Lymphovascular Invasion
Time frame: Baseline up to 30 months
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Percentage of Participants With PR Status (Positive or Negative) Across Different Age Groups
Time frame: Baseline up to 30 months
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.
Percentage of Participants With PR Status (Positive or Negative) Based on Nuclear Grades
Time frame: Baseline up to 30 months
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.
Percentage of Participants With PR Status (Positive or Negative) Based on Lymphovascular Invasion
Time frame: Baseline up to 30 months
Lymphovascular invasion is entering of breast cancer cells in to the lymph or vascular/blood channels.
Percentage of Participants With HER2 Status (Positive or Negative) Across Different Age Groups
Time frame: Baseline up to 30 months
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.
Percentage of Participants With HER2 Status (Positive or Negative) Based on Nuclear Grades
Time frame: Baseline up to 30 months
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.
Percentage of Participants With HER2 Status (Positive or Negative) Based on Lymphovascular Invasion
Time frame: Baseline up to 30 months
Lymphovascular invasion is entering of breast cancer cells in to the lymph or blood/vascular channels.
Percentage of Participants With Different Phenotypes of Breast Cancer Across Different Age Groups
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Nuclear Grades
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer Based on Lymphovascular Invasion
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer Based on ER Status
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer Based on PR Status
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Different Phenotypes of Breast Cancer Based on HER2 Status
Time frame: Baseline up to 30 months
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.
Percentage of Participants With Breast Cancer Phenotypes Among Different Hispanic Countries
Time frame: Baseline up to 30 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Peru, Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline up to 30 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.