TN ER-/PR-/HER2- Breast CancerNCT03981705
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
An observational study of TN ER-/PR-/HER2- Breast Cancer and Triple Negative Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Standard Trimodality Breast Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2019to 26 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
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.
- Conditions
- TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
- Being tested
- Standard Trimodality Breast Imaging
- Keywords
- Breast Cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Trimodality Breast ImagingRadiation
Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Pathologic Response (pCR)
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.
Measured: 6 Months Post Surgery
Secondary outcomes (1)
Complications and Side Effects of the Needle Biopsy Procedure after NAC
Incidence of Adverse Events
Measured: 6 Months Post Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2019
- Study start8 Aug 2019
- Primary completion19 Feb 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TN ER-/PR-/HER2- Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Tuttle, MD, MS, Principal investigator, Department of Surgery, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981705
- Sponsor's protocol ID
- 2018NTLS176
- Status last verified
- Dec 2024
- First submitted
- 7 Jun 2019
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT03981705
- Acronym / sponsor ID
- 2018NTLS176
- Conditions
- TN ER-/PR-/HER2- Breast Cancer, Triple Negative Breast Cancer, HER2-positive Breast Cancer, ERany/PRany/HER2+ Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 11 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Trimodality Breast ImagingStandard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC). | Radiation | – |
Primary outcome
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.
1 secondary outcome
Complications and Side Effects of the Needle Biopsy Procedure after NAC
Time frame: 6 Months Post Surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Tuttle, MD, MS principal investigator
Department of Surgery, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TN ER-/PR-/HER2- Breast Cancer and Triple Negative Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Pathologic Response (pCR) (time frame: 6 Months Post Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.