Triple Negative Breast CancerNCT02247037
Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer
An observational study of Triple Negative Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Chemotherapy
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to 22 Jan 2019
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Triple Negative Breast Cancer that are eligible for neoadjuvant chemotherapy or have evidence of metastatic disease will be pursued for this protocol.
Who may be able to join
- a histological diagnosis of invasive triple negative breast cancer determined by standard immunohistochemical analysis.
- must be candidates for neoadjuvant chemotherapy according to standard of care guidelines or have evidence of metastatic disease.
- must agree to a biopsy for research purposes at time of diagnosis and to undergo surgery at the hospitals of the Mount Sinai Health System.
- Patients with the following MAY be eligible:
- a histological diagnosis of ER and/or PR positive breast cancer with an overall receptor expression ≤ 30% breast cancer determined by standard immunohistochemical analysis
Who cannot join
- concurrent disease or condition that would make the patient inappropriate for study participation,
- any serious medical or psychiatric disorder that would interfere with the subject's safety, or inability to provide informed consent.
- vulnerable populations will not be included.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai
New York, New York, 10029
About this study
This study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. The collection of patient tumor tissue will also provide insight into the mechanisms of therapeutic resistance for those individuals. Ultimately, this study will enhance our understanding of the genomic basis for treatment response for triple negative cancer on an individual basis, while having the potential to suggest new therapeutic options for high-risk triple negative breast cancer patients with residual disease post neoadjuvant.
Read the detailed description
Triple negative breast cancer (TNBC) represents an aggressive, genomically heterogeneous, subtype of breast cancer with limited therapeutic options. Many patients with TNBC receive standard neoadjuvant chemotherapy (NAC) pre-operatively; response is directly correlated with long-term outcome. Patients with residual disease after NAC are at higher risk for recurrent or metastatic disease, but additional adjuvant therapies are not currently part of standard care. Personalized treatment for patients with TNBC requires an improved understanding of the genomic landscape of individual TN breast tumors, as well as improved predictive models of response to specific therapeutic agents. This pilot study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with TNBC. The tumor tissue collected (paired pre-and post NAC) will also provide insight into mechanisms of therapeutic resistance for individual patients. This study will enhance our understanding of the genomic basis for treatment response for TNBC on an individual patient basis, and lead to potential new therapeutic options for high-risk TNBC patients with post-NAC residual disease.
Objectives:
- To collect and bank tissue specimens from patients with operable triple negative breast cancer at: a) at time of diagnosis, prior to the start of neoadjuvant therapy and b) at time of definitive surgery, after the completion of neoadjuvant therapy.
- To collect and bank tissue specimen for patients with advanced metastatic triple negative disease prior to start of any line therapy for metastatic disease.
- To create patient-derived xenograft (PDX) mouse models utilizing specimens collected pre- and post- neoadjuvant treatment
- To determine if response of PDX tumors to cytotoxic agents in the Champions Oncology Tumor GraftTM (COTG) assay correlates with responses observed in patients.
- To perform genomic analyses of patient tumor specimens collected pre- and post neoadjuvant treatment to study mechanisms of drug resistance
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Chemotherapy
- Keywords
- Triple Negative Breast Cancer, Patient Derived Xenograft, Neoadjuvant Chemotherapy, Therapeutic Resistance
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyOther
Patients are treated with neoadjuvant chemotherapy as according to the standard of care guidelines. Patients with metastatic disease are treated according to standard of care guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancers | All women eligible for this protocol will fall into this group. These women will have histologically confirmed triple negative breast cancer and be eligible for neoadjuvant chemotherapy or have evidence of metastatic disease. Receives: Other: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Tumor Response
Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response
Measured: Day 1
Secondary outcomes (1)
Model Tumor Response
Tumor response in models will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startJul 2014
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Champions Oncology
- Responsible party
- Principal investigator, Hanna Irie, Icahn School of Medicine at Mount Sinai
- Investigators
- Hanna Yoko Irie, MD, PhD, Principal investigator, Dubin Breast Center of The Tisch Cancer Institute at Mount SinaiElisa Port, MD, Principal investigator, Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247037
- Sponsor's protocol ID
- GCO 14-0686
- Status last verified
- Jul 2020
- First submitted
- 19 Sep 2014
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Xenograft (PDX) Modeling of Treatment Response for Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT02247037
- Acronym / sponsor ID
- GCO 14-0686
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Patient Derived Xenograft, Neoadjuvant Chemotherapy, Therapeutic Resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Champions Oncology
- Study start
- Jul 2014
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 23 Sep 2014 (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 study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with triple negative breast cancer. The collection of patient tumor tissue will also provide insight into the mechanisms of therapeutic resistance for those individuals. Ultimately, this study will enhance our understanding of the genomic basis for treatment response for triple negative cancer on an individual basis, while having the potential to suggest new therapeutic options for high-risk triple negative breast cancer patients with residual disease post neoadjuvant.
Detailed description
Triple negative breast cancer (TNBC) represents an aggressive, genomically heterogeneous, subtype of breast cancer with limited therapeutic options. Many patients with TNBC receive standard neoadjuvant chemotherapy (NAC) pre-operatively; response is directly correlated with long-term outcome. Patients with residual disease after NAC are at higher risk for recurrent or metastatic disease, but additional adjuvant therapies are not currently part of standard care. Personalized treatment for patients with TNBC requires an improved understanding of the genomic landscape of individual TN breast tumors, as well as improved predictive models of response to specific therapeutic agents. This pilot study will determine if patient-derived tumor xenograft (PDX) mouse models can serve as a reliable model for treatment response for individual patients with TNBC. The tumor tissue collected (paired pre-and post NAC) will also provide insight into mechanisms of therapeutic resistance for individual patients. This study will enhance our understanding of the genomic basis for treatment response for TNBC on an individual patient basis, and lead to potential new therapeutic options for high-risk TNBC patients with post-NAC residual disease.
Objectives:
- To collect and bank tissue specimens from patients with operable triple negative breast cancer at: a) at time of diagnosis, prior to the start of neoadjuvant therapy and b) at time of definitive surgery, after the completion of neoadjuvant therapy.
- To collect and bank tissue specimen for patients with advanced metastatic triple negative disease prior to start of any line therapy for metastatic disease.
- To create patient-derived xenograft (PDX) mouse models utilizing specimens collected pre- and post- neoadjuvant treatment
- To determine if response of PDX tumors to cytotoxic agents in the Champions Oncology Tumor GraftTM (COTG) assay correlates with responses observed in patients.
- To perform genomic analyses of patient tumor specimens collected pre- and post neoadjuvant treatment to study mechanisms of drug resistance
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancers | – | Other: ChemotherapyAll women eligible for this protocol will fall into this group. These women will have histologically confirmed triple negative breast cancer and be eligible for neoadjuvant chemotherapy or have evidence of metastatic disease. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Triple Negative Breast Cancer that are eligible for neoadjuvant chemotherapy or have evidence of metastatic disease will be pursued for this protocol.
Key inclusion criteria (5 listed)
- a histological diagnosis of invasive triple negative breast cancer determined by standard immunohistochemical analysis.
- must be candidates for neoadjuvant chemotherapy according to standard of care guidelines or have evidence of metastatic disease.
- must agree to a biopsy for research purposes at time of diagnosis and to undergo surgery at the hospitals of the Mount Sinai Health System.
- a histological diagnosis of ER and/or PR positive breast cancer with an overall receptor expression ≤ 30% breast cancer determined by standard immunohistochemical analysis
Key exclusion criteria (3 listed)
- concurrent disease or condition that would make the patient inappropriate for study participation,
- any serious medical or psychiatric disorder that would interfere with the subject's safety, or inability to provide informed consent.
- vulnerable populations will not be included.
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 |
|---|---|---|
| ChemotherapyPatients are treated with neoadjuvant chemotherapy as according to the standard of care guidelines. Patients with metastatic disease are treated according to standard of care guidelines. | Other | Triple Negative Breast Cancers |
Primary outcome
Patient Tumor Response
Time frame: Day 1
Tumor response in patients will be categorized as: Progressive Disease, Static Response, Partial Response, Complete Response
1 secondary outcome
Model Tumor Response
Time frame: Day 1
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 7 Jul 2020.
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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.
Hanna Yoko Irie, MD, PhD principal investigator
Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai
Elisa Port, MD principal investigator
Dubin Breast Center of The Tisch Cancer Institute at Mount Sinai
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 Triple Negative Breast Cancer, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 5 inclusion and 3 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 7 Jul 2020. 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 United States. 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?
Patient Tumor Response (time frame: Day 1). 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 7 Jul 2020.