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出境医 / 临床实验 / Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| TN ER-/PR-/HER2- Breast Cancer Triple Negative Breast Cancer HER2-positive Breast Cancer ERany/PRany/HER2+ Breast Cancer | Radiation: Standard Trimodality Breast Imaging |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 40 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer |
| Actual Study Start Date : | August 8, 2019 |
| Estimated Primary Completion Date : | January 2025 |
| Estimated Study Completion Date : | January 2025 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- Complications and Side Effects of the Needle Biopsy Procedure after NAC [ Time Frame: 6 Months Post Surgery ]Incidence of Adverse Events
Eligibility Criteria
Contacts and Locations
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 7, 2019 | ||||
| First Posted Date | June 11, 2019 | ||||
| Last Update Posted Date | August 12, 2020 | ||||
| Actual Study Start Date | August 8, 2019 | ||||
| Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
Complications and Side Effects of the Needle Biopsy Procedure after NAC [ Time Frame: 6 Months Post Surgery ] Incidence of Adverse Events
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for Breast Cancer | ||||
| Official Title | Assessment of Complete Pathologic Response After Neoadjuvant Chemotherapy for 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
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| Intervention | Radiation: Standard Trimodality Breast Imaging
Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).
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| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Recruiting | ||||
| Estimated Enrollment |
40 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | January 2025 | ||||
| Estimated Primary Completion Date | January 2025 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03981705 | ||||
| Other Study ID Numbers | 2018NTLS176 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Masonic Cancer Center, University of Minnesota | ||||
| Study Sponsor | Masonic Cancer Center, University of Minnesota | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Masonic Cancer Center, University of Minnesota | ||||
| Verification Date | August 2020 | ||||
