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NCT Number: NCT04703244

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Residual Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Judy C. Boughey, M.D.

PRINCIPAL_INVESTIGATOR

Matthew P. Goetz, M.D.

PRINCIPAL_INVESTIGATOR

About this study

This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.

Because there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

chemotherapy or endocrine therapy for breast cancer

Procedure

Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.

Primary outcomes

  1. Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

Secondary outcomes

  1. Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  2. Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  3. Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  4. Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  5. Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  6. Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

  7. Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response

    Time frame: Up to 12 months until death or a maximum of 20 years post registration

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2041
Study completion
2042
First posted
Jan 11, 2021
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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