Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer

Breast Cancer Clinical Trial

Official title:

Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04703244
• Other study ID #: MC1933
• Status: Recruiting
• Start date: January 13, 2021
• Est. completion date: January 15, 2042

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: Clinical Trials Referral Office
• Phone: 855-776-0015
• Email: mayocliniccancerstudies[@]mayo.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2042
• Est. primary completion date: January 15, 2041
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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:

1. Received at least 2 weeks of neoadjuvant endocrine therapy

2. Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging

3. 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Residual

Intervention

Procedure:
• chemotherapy or endocrine therapy for breast cancer
Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance		Up to 12 months until death or a maximum of 20 years post registration
Secondary	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		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden		Up to 12 months until death or a maximum of 20 years post registration
Secondary	Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response		Up to 12 months until death or a maximum of 20 years post registration

External Links

•   Mayo Clinic Clinical Trials