RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-13

Study Completion:2042-01-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04703244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 1. Received at least 2 weeks of neoadjuvant endocrine therapy 2. Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging 3. 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.	* 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).

Inclusion Criteria

Exclusion 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:
1. Received at least 2 weeks of neoadjuvant endocrine therapy
2. Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging
3. 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.

* 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).

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Judy C. Boughey, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Matthew P. Goetz, M.D.

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Judy C. Boughey, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic
Matthew P. Goetz, M.D., PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-01-13

Study Completion Date2042-01-15

Study Record Updates

Study Start Date2021-01-13

Study Completion Date2042-01-15

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer
Residual