Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
Recruiting · NCT04703244 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
chemotherapy or endocrine therapy for breast cancer
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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:
- Received at least 2 weeks of neoadjuvant endocrine therapy
- Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
- 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).
Where it is running
1 location listed across 1 US state.
- Mayo Clinic - Rochester, Minnesota, United States