Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

NCT02580799 | Completed Results

• 1 other identifier: ML28731
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (8)

• Percentage of Participants With Immunohistochemical (IHC) Evaluation Between Site A and Others (Sites B, C, D and E)

  IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have Human Epidermal Growth Receptor (HER2) and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.

  Up to 70 days

• Kappa Coefficient (K) as a Measure of Agreement Between Site A and Others (Sites B, C, D and E) Concerning the IHC Test of Breast Tissue Samples

  Inter-laboratory variation between the sites was assessed using Kappa test, K values were interpreted as follows: a) less than (\<) 0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.

  Up to 70 days

• Percentage of Participants With IHC Evaluation Between Sites B and Others (Sites C, D and E)

  IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.

  Up to 70 days

• Kappa Coefficient as a Measure of Agreement Between Site B and Others (Sites C, D and E) Concerning the IHC Test of Breast Tissue Samples

  Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.

  Up to 70 days

• Percentage of Participants With IHC Evaluation Between Site C and Others (Sites D and E)

  IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.

  Up to 70 days

• Kappa Coefficient as a Measure of Agreement Between Sites C, D and E Concerning the IHC Test of Breast Tissue Samples

  Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.

  Up to 70 days

• Percentage of Participants With IHC Evaluation Between Abroad and Trial Sites (A, B, C, D and E)

  IHC is a staining process performed on fresh/frozen breast cancer tissue. IHC is used to show whether or not the cancer cells have HER2 and/or hormone receptors on their surface. The IHC test gives a score of 0 to 3+ that measures the amount of HER2 receptor protein on the surface of cells in a breast cancer tissue sample. Score 0: cells free from immune staining, score 1 (+): is concluded in the case of stains not completely membranous and which do not surround the membranes regardless of quantity in the cells, or weak stains surrounding the entire membrane in less than 10% of the cells. Score 2 (++): is concluded in the presence of a moderate staining surrounding the cytoplasmic membrane in at least 10%, or strong membranous staining in less than 30% of the invasive carcinoma cells. Score 3 (+++): is concluded where IHC yields strong staining surrounding the entire cytoplasmic membrane in at least 30% of the invasive carcinoma cells.

  Up to 70 days

• Kappa Coefficient as a Measure of Agreement Between Abroad and Trial Sites (A, B, C, D and E) Concerning the IHC Test of Breast Tissue Samples

  Inter-laboratory variation between the sites was assessed using Kappa test, K values to be interpreted as follows: a) \<0: less than chance agreement, b) 0.01-0.20: slight agreement, c) 0.21-0.40: fair agreement, d) 0.41-0.60: moderate agreement, e) 0.61-0.80: substantial agreement, and f) 0.81-0.99: almost perfect agreement.

  Up to 70 days

Secondary Outcomes (11)

• Percentage of Participants With Diagnosis of Primary Tumor

  Up to 70 days

• Percentage of Participants With Initial Tumor Node Metastasis (TNM) Stage According to Council Decision

  Up to 70 days

• Percentage of Participants With Pathological Score

  Up to 70 days

• Percentage of Participants With Pathological Grade

  Up to 70 days

• Percentage of Participants With Different Hormone Receptors

  Up to 70 days

Study Arms (1)

Breast Cancer Pathology Samples

Breast cancer pathology samples were evaluated for a period of 70 days.

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast tissue samples from female participants with a breast cancer diagnosis

You may qualify if:

• Samples that fulfill all of the criteria will be evaluated for the study.
• Samples of women aged greater than or equal to (\>/=) 18 and less than (\<) 75 years
• Tumor samples already diagnosed based on the IHC score of 0 to +3
• Samples of primary lesions excluding lymph nodes
• percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples

You may not qualify if:

• Samples that fulfill any of the criteria below will not be included in the study.
• Non-invasive ductal carcinoma (NOS) samples
• Tru-cut biopsies
• Non-breast cancer pathological samples

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (5)

Ankara University Medical Faculty

Ankara, 06230, Turkey (Türkiye)

Location

Istanbul University Istanbul Medical Faculty

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, 34098, Turkey (Türkiye)

Location

Ege University Medical Faculty

Izmir, 35100, Turkey (Türkiye)

Location

Dokuz Eylul University Medical Faculty

Izmir, 35210, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2015
• First Posted: October 20, 2015
• Study Start: February 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 22, 2016
• Results First Posted: February 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (5)