Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT04703244

Conditions

Breast Cancer

Residual

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

chemotherapy or endocrine therapy for breast cancer

Study Details

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.

Conditions

Breast Cancer

Residual

Study ID

NCT04703244

Start date

Jan 13, 2021

Status verified date

Feb, 2026

Completion date

Jan 15, 2042

Anticipated

Primary completion date

Jan 15, 2041

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

999 participants

Anticipated

Interventions and Outcome Measures

Interventions

chemotherapy or endocrine therapy for breast cancer

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Judy C. Boughey, M.D.

More Information

Sponsor

Mayo Clinic

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-03-03.