Breast CancerNCT04703244
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
An observational study of Breast Cancer and Residual, run by Mayo Clinic at 1 site in United States.
Trial summary
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Residual
- What is being tested?
- chemotherapy or endocrine therapy for breast cancer
- Type of treatment
- Surgery or procedure
- How many people
- 999 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2021to 15 Jan 2042
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients who have completed neoadjuvant systemic therapy who have residual disease on post-neoadjuvant imaging and are planning surgical resection
Who may be able to join
- Age ≥18 years.
- Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
- Surgically resectable disease following neoadjuvant systemic treatment.
- At least one of the following must be true:
- Received at least 2 weeks of neoadjuvant endocrine therapy
- Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
Show all 12Show fewer
- Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination
- Provide written informed consent.
- Willing to return to enrolling institution for breast cancer surgery.
- Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.
- Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.
Who cannot join
- Ineligible for surgery.
- History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Judy C. Boughey, M.D.
About this study
Official title: Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death.
Read the detailed description
This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.
Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.
Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.
- Conditions
- Breast Cancer, Residual
- Being tested
- chemotherapy or endocrine therapy for 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.
chemotherapy or endocrine therapy for breast cancerProcedure or surgery
Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy
Measured: Up to 12 months until death or a maximum of 20 years post registration
Secondary outcomes (7)
Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations
Measured: Up to 12 months until death or a maximum of 20 years post registration
Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance
Measured: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden
Measured: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden
Measured: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden
Measured: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden
Measured: Up to 12 months until death or a maximum of 20 years post registration
Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response
Measured: Up to 12 months until death or a maximum of 20 years post registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start13 Jan 2021
- Primary completion15 Jan 2041 (estimated)
- Study completion15 Jan 2042 (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 Mayo ClinicThe 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
- 999 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judy C. Boughey, M.D., Principal investigator, Mayo ClinicMatthew P. Goetz, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703244
- Sponsor's protocol ID
- MC1933
- Status last verified
- Feb 2026
- First submitted
- 7 Jan 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy
- ClinicalTrials.gov ID
- NCT04703244
- Acronym / sponsor ID
- MC1933
- Conditions
- Breast Cancer, Residual
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- 15 Jan 2041 (estimated)
- Study completion
- 15 Jan 2042 (estimated)
- First posted
- 11 Jan 2021 (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.
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (>50%) risk of future life-threatening recurrences and death.
Detailed description
This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.
Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.
Blood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have completed neoadjuvant systemic therapy who have residual disease on post-neoadjuvant imaging and are planning surgical resection
Key inclusion criteria (12 listed)
- Age ≥18 years.
- Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.
- Surgically resectable disease following neoadjuvant systemic treatment.
- At least one of the following must be true:
- Provide written informed consent.
Key exclusion criteria (2 listed)
- Ineligible for surgery.
- History of prior malignancy <3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
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 |
|---|---|---|
| chemotherapy or endocrine therapy for breast cancerCollect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. | Procedure or surgery | – |
Primary outcome
Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy
Time frame: Up to 12 months until death or a maximum of 20 years post registration
7 secondary outcomes
Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response
Time frame: Up to 12 months until death or a maximum of 20 years post registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Judy C. Boughey, M.D. principal investigator
Mayo Clinic
Matthew P. Goetz, M.D. principal investigator
Mayo Clinic
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 Residual, run by Mayo Clinic 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 12 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy (time frame: Up to 12 months until death or a maximum of 20 years post registration). 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 3 Mar 2026.