Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

February 20, 2024 updated by: Masonic Cancer Center, University of Minnesota
This is a feasibility study to gain preliminary information regarding whether breast imaging with or without a core needle biopsy after neoadjuvant chemotherapy (NAC) but before surgery can accurately predict complete pathologic response (pCR) in women with triple negative or HER2- positive breast cancer. pCR is defined as having no residual invasive breast cancer or ductal carcinoma in situ.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Masonic Cancer Center

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study entry is open to women 18 years of age and older regardless of race or ethnic background. While there will be every effort to seek out and include minority patients, the patient population is expected reflect those at the University of Minnesota with triple negative or HER2+ breast cancer.

Description

Inclusion Criteria:

  • Biopsy proven triple negative (TN) (ER-/PR-/HER2-) or HER2 positive (ERany/PRany/HER2+) breast cancer for which neoadjuvant chemotherapy is planned
  • A biopsy clip placed at the time of diagnostic biopsy
  • 18 years of age or older
  • Must be able to read and write in English due to the importance of survey (questionnaire) completion to meet the study's endpoint - this is justified as there is no individual benefit to study participation
  • Able to provide written consent prior to any research related activities

Exclusion Criteria:

  • Stage IV breast cancer
  • T4 breast cancer
  • Previous ipsilateral breast cancer
  • Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Pathologic Response (pCR)
Time Frame: 6 Months Post Surgery
The primary aim of this feasibility study is to determine whether breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC) can accurately predict complete pathologic response (pCR) in women with biopsyproven triple negative or HER2+ breast cancer.
6 Months Post Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications and Side Effects of the Needle Biopsy Procedure after NAC
Time Frame: 6 Months Post Surgery
Incidence of Adverse Events
6 Months Post Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Todd Tuttle, MD, MS, Department of Surgery, University of Minnesota

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 Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Actual)

February 19, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018NTLS176

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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