Breast CancerNCT04021069
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
An observational study of Breast Cancer and Invasive Ductal Breast Carcinoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Invasive Ductal Breast Carcinoma, Invasive Lobular Breast Carcinoma
- What is being tested?
- Radiomic, pathomic, and clinical markers
- How many people
- 800 participants
- Where
- 1 siteCanada
- Study dates
- 30 Aug 2018to 30 Aug 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer of any stage, according to the AJCC v7 criteria.
Who may be able to join
- Participants must be men and women age 18+
- Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
- Any state of disease as described by AJCC v7 criteria
- Participants must have received and completed neoadjuvant chemotherapy
Who cannot join
- Participants who had other primary cancers prior to breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
Read the detailed description
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.
- Being tested
- Radiomic, pathomic, and clinical markers
- Keywords
- radiomics, pathomics, breast cancer, machine learning, biomarkers
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomic, pathomic, and clinical markersDiagnostic test
This is a non-interventional study.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
Evaluating the degree of absence of residual cancer cells
Measured: Up to 60 months
Secondary outcomes (3)
Time to local breast recurrence
Evaluating the time until a recurrence event has occurred in the breast
Measured: Up to 60 months
Time to distant metastasis (months)
Evaluating onset of distant metastasis
Measured: Up to 60 months
Time to death
Evaluating time to cancer-related death
Measured: Up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start30 Aug 2018
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. William Tran, Sunnybrook Health Sciences Centre
- Investigators
- William T. Tran, MRT(T), PhD, Principal investigator, Sunnybrook Health Sciences CentreKasia Jerzak, M.Sc., MD, Principal investigator, Sunnybrook Health Sciences CentreFang-I Lu, MD, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04021069
- Sponsor's protocol ID
- 270-2018
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
- ClinicalTrials.gov ID
- NCT04021069
- Acronym / sponsor ID
- 270-2018
- Keywords
- radiomics, pathomics, breast cancer, machine learning, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 16 Jul 2019 (actual)
- 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 study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
Detailed description
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll women and men with a pathologically-confirmed diagnosis of invasive breast cancer of any stage, according to the AJCC v7 criteria.
Key inclusion criteria (4 listed)
- Participants must be men and women age 18+
- Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
- Any state of disease as described by AJCC v7 criteria
- Participants must have received and completed neoadjuvant chemotherapy
Key exclusion criteria (1 listed)
- Participants who had other primary cancers prior to breast cancer
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 |
|---|---|---|
| Radiomic, pathomic, and clinical markersThis is a non-interventional study. | Diagnostic test | – |
Primary outcome
Pathologic complete response (pCR)
Time frame: Up to 60 months
Evaluating the degree of absence of residual cancer cells
3 secondary outcomes
Time to local breast recurrence
Time frame: Up to 60 months
Time to distant metastasis (months)
Time frame: Up to 60 months
Time to death
Time frame: Up to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: Yes. All data will be anonymized. Digital pathology images and anonymized clinical data will be deposited into the National Cancer Institute (NCI) data sharing repository, including The Cancer Imaging Archive (TCIA). Digital pathology images will also be annotated to facilitate analysis for other investigators. Computational methods, source-codes and instructions will be deposited to the open-source coding repository, GitHub (www.github.com).
Related trials for Breast Cancer
Active, not recruiting
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
Bone Metastases, HER2-positive Breast Cancer
Active, not recruitingObservational study
A ReaL World Study of DS-8201
Breast Cancer Metastatic, Treatment Efficacy
RecruitingPhase 3
A Clinical Study of Patritumab Deruxtecan to Treat Breast Cancer (MK-1022-016)
Breast Neoplasms
RecruitingObservational study
Characterization of Extracellular Vesicles in Breast Cancer Patients
Breast Cancer
Not yet recruitingPhase 4
Evaluation of the Efficacy and Acceptability of a Phytotherapy Combining Devil's Claw, Blackcurrant and Meadowsweet for the Management of Aromatase Inhibitor-induced Arthralgia in Patients Treated for Localized Breast Cancer in the Adjuvant Setting
Hormone Therapy-induced Arthralgia, Phytotherapy
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.
William T. Tran, MRT(T), PhD principal investigator
Sunnybrook Health Sciences Centre
Kasia Jerzak, M.Sc., MD principal investigator
Sunnybrook Health Sciences Centre
Fang-I Lu, MD, FRCPC principal investigator
Sunnybrook Health Sciences Centre
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 Breast Cancer and Invasive Ductal Breast Carcinoma, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jul 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 Canada. 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?
Results are not available in the source record.
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?
Pathologic complete response (pCR) (time frame: Up to 60 months). 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 16 Jul 2019.