Invasive Breast CancerNCT02773784
Comparison of CNB and Surgical Specimens for ER, PgR, HER2 Status and Ki67 Index in Invasive Breast Cancer.
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
Trial summary
This is a prospective, single-center, non-randomized, non-controlled study. The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Invasive Breast Cancer
- What is being tested?
- immunohistochemistry and/or FISH
- How many people
- 314 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: invasive breast cancer diagnosed by core needle biopsy
Who may be able to join
- • histologically confirmed primary invasive breast cancer by core needle biopsy
Who cannot join
- • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy
- patient plans to receive neo-adjuvant system therapy
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
About this study
Official title: Comparison of Core Needle Biopsy (CNB) and Surgical Specimens for Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal Growth Factor Receptor 2 (HER2) Status and Ki67 Index in Invasive Breast Cancer.
- This is a prospective, single-center, non-randomized, non-controlled study.
- The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.
- Conditions
- Invasive Breast Cancer
- Being tested
- immunohistochemistry and/or FISH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemistry and/or FISHOther
Patients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples.
| Study group | Role | What they receive |
|---|---|---|
| invasive breast cancer | Patients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples. Receives: Other: immunohistochemistry and/or FISH |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) will be assessed by four parameters respectively, which are sensitivity, specificity, the negative predictive values and the positive predictive values, using the surgical specimens as reference.
Measured: within 4 weeks after obtaining the post-surgery pathological results
Secondary outcomes (1)
Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.
Measured: within 4 weeks after obtaining the post-surgery pathological results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startSep 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tao OUYANG, Peking University
- Investigators
- Zhao-Qing Fan, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773784
- Sponsor's protocol ID
- BCP16
- Status last verified
- Jan 2019
- First submitted
- 16 Sep 2015
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Core Needle Biopsy (CNB) and Surgical Specimens for Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal Growth Factor Receptor 2 (HER2) Status and Ki67 Index in Invasive Breast Cancer.
- ClinicalTrials.gov ID
- NCT02773784
- Acronym / sponsor ID
- BCP16
- Conditions
- Invasive Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Sep 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
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 prospective, single-center, non-randomized, non-controlled study.
- The estrogen receptor (ER), progesterone receptor (PgR), HER2 status and Ki67 index of CNB specimen are critical biomarkers for making neoadjuvant therapy strategy in invasive breast cancer. The concordance of these biomarkers between CNB and surgical specimen was varied in previous retrospective reports. The aim of this study is to determine the discordance of these biomarkers between CNB and surgical specimen and the influence of making treatment strategy by the discordance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| invasive breast cancer | – | Other: immunohistochemistry and/or FISHPatients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- invasive breast cancer diagnosed by core needle biopsy
Key inclusion criteria (1 listed)
- • histologically confirmed primary invasive breast cancer by core needle biopsy
Key exclusion criteria (2 listed)
- • pathological diagnosed ductal carcinoma in situ or microinvasive breast cancer by core needle biopsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemistry and/or FISHPatients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples. | Other | invasive breast cancer |
Primary outcome
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively.
Time frame: within 4 weeks after obtaining the post-surgery pathological results
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) will be assessed by four parameters respectively, which are sensitivity, specificity, the negative predictive values and the positive predictive values, using the surgical specimens as reference.
1 secondary outcome
Discordance of system therapy strategies between using biomarkers of CNB and surgical specimens.
Time frame: within 4 weeks after obtaining the post-surgery pathological results
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
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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.
Zhao-Qing Fan, MD principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer, run by Peking University at 1 site in China.
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 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The accuracy of ER, PgR, Her-2 and Ki67 for core needle biopsy (CNB) using the surgical specimens as reference, respectively. (time frame: within 4 weeks after obtaining the post-surgery pathological results). 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 18 Jan 2019.