Status:
UNKNOWN
Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer
Lead Sponsor:
Shandong Cancer Hospital and Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Neoadjuvant chemotherapy (NAC) is widely used as an efficient breast cancer treatment. Ideally, a pathological complete remission (pCR) can be achieved. With improvements in molecular typing guided NA...
Detailed Description
In clinical routine surgical treatment follows the neoadjuvant chemotherapy (NAC). However, recent studies have demonstrated that shrinking tumors need less surgical treatment indicating that patients...
Eligibility Criteria
Inclusion
- after full-course neoadjuvant chemotherapy (NAC) according to the NACT protocol
- with cT1c-cT4a-c tumors
- after informed consent
- with breast ultrasound, mammography (and breast MRI where necessary) before and after NACT
- Clinical / imaging partial or complete response to NAC
- Any routine breast cancer surgical intervention planned according to guidelines (breast conservation or mastectomy)
- Residual intramammary target lesion or clip marker is visible in ultrasound and / or mammography
- Inclusion of only one breast per patient, in bilateral cancer one breast can be included
- In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.
Exclusion
- Palliative or recurrent breast cancer
- Pregnancy and lactation
- cT4d stage (inflammatory breast cancer)
- M1 stages
- stable disease according to a multimodal assessment of ultrasound, mammography and breast MRI (if available) according to RECIST
- dislocation of marker (\> 10mm distance to the initial lesion)
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03789851
Start Date
June 1 2017
End Date
June 1 2020
Last Update
December 31 2018
Active Locations (1)
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1
Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University
Jinan, China, 250117