NCT04703244 Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
| NCT ID | NCT04703244 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 999 participants |
| Start Date | 2021-01-13 |
| Primary Completion | 2041-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 999 participants in total. It began in 2021-01-13 with a primary completion date of 2041-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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).
Contact & Investigator
Judy C. Boughey, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04703244 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04703244 currently recruiting?
Yes, NCT04703244 is actively recruiting participants. Contact the research team at mayocliniccancerstudies@mayo.edu for enrollment information.
Where is the NCT04703244 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04703244 clinical trial?
NCT04703244 is sponsored by Mayo Clinic. The principal investigator is Judy C. Boughey, M.D. at Mayo Clinic. The trial plans to enroll 999 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.