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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study aims to make breast cancer research models using patients’ tumor tissue. It is for adults with breast cancer who had drug treatment before surgery and can have their cancer removed by surgery.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You have invasive breast cancer, which has grown into nearby breast tissue, and had drug treatment before surgery.
  • Your cancer can be removed by surgery after drug treatment.
  • At least one applies: you had hormone-blocking treatment for at least 2 weeks; you had chemotherapy for at least 2 months and scans suggest cancer remains; or you stopped either treatment because an MRI, ultrasound, or physical exam showed the cancer was growing.
  • You sign a form agreeing to take part after learning about the study.
  • You are willing to return to the center where you joined the study for breast cancer surgery.
  • You are willing to give required blood and tissue samples for future breast cancer research at Mayo Clinic.
  • You are willing to give required tissue samples to make research models at Mayo Clinic: patient-derived xenografts (tumors grown in animals) and organoids (small tissue models grown in a lab).

Who can't join

  • You cannot have surgery.
  • You had another cancer less than 3 years before signing up. Exceptions include non-melanoma skin cancer, papillary thyroid cancer, and cancer that has not grown into nearby tissue, such as early cancer limited to the surface of the cervix.

Simplified for readability. The official criteria below are what the study team uses.

Official 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).

Study sites (1)

MN