Creating patient-derived cancer models from breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.