Creating patient-derived cancer models from breast cancer patients
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy
This study is trying to create models from leftover tissue and blood of breast cancer patients to learn more about their cancer and find better treatments for the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 999 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04703244 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect blood and leftover surgical tissue from breast cancer patients who have residual disease after undergoing neoadjuvant systemic therapy. The collected samples will be used to develop patient-derived xenografts (PDX) and organoids to better understand the characteristics of residual breast cancer. By analyzing these samples, researchers hope to identify biomarkers and potential new treatment strategies for future breast cancer patients. The study focuses on patients with invasive breast cancer who have undergone specific treatment regimens and are willing to provide samples for research.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with invasive breast cancer who have undergone neoadjuvant systemic therapy and have residual disease post-treatment.
Not a fit: Patients who do not have residual breast cancer after treatment or those who are not eligible for neoadjuvant systemic therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for future breast cancer patients with residual disease.
How similar studies have performed: Other studies utilizing patient-derived xenografts have shown promise in understanding cancer biology and developing targeted therapies, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- Mayo Clinic — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Judy C. Boughey, M.D. — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.