NCT04703244

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
191mo left

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Jan 2021Jan 2042

First Submitted

Initial submission to the registry

January 7, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 13, 2021

Completed
20 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2041

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2042

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

20 years

First QC Date

January 7, 2021

Last Update Submit

February 27, 2026

Conditions

Breast CancerResidual

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (7)

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

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

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

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

  • 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

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

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

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

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

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

  • +2 more secondary outcomes

Interventions

chemotherapy or endocrine therapy for breast cancerPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who have completed neoadjuvant systemic therapy who have residual disease on post-neoadjuvant imaging and are planning surgical resection

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and Tissue

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Judy C. Boughey, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Matthew P. Goetz, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015mayocliniccancerstudies@mayo.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2021

First Posted

January 11, 2021

Study Start

January 13, 2021

Primary Completion (Estimated)

January 15, 2041

Study Completion (Estimated)

January 15, 2042

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)