Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03981705

Enrollment

Registered

2019-06-11

Start date

2019-08-08

Completion date

2024-11-26

Last updated

2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ERany/PRany/HER2+ Breast Cancer, HER2-positive Breast Cancer, TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer

Keywords

Breast Cancer

Brief summary

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.

Interventions

RADIATIONStandard Trimodality Breast Imaging

Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Complete Pathologic Response (pCR)	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.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026