NCT03981705Completed
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Source: ClinicalTrials.gov · Last updated 27 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 8 (actual)
- First submitted
- 7 Jun 2019
- Start date
- 8 Aug 2019
- Primary completion date
- 19 Feb 2024
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT03981705
What you commit to
- Study type: Observational
- Participants enrolled: 8
- From 8 Aug 2019 to the primary completion date, 19 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ipsilateral breast cancer
- Any contraindication for undergoing a contrast-enhanced breast MRI and/or the breast biopsy between chemotherapy and surgery
Other illness
- Stage IV breast cancer
- T4 breast cancer
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota/Masonic Cancer Center Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.