Breast Cancer Clinical Trial
— MIBPBPCROfficial title:
Minimally Invasive Biopsy Technique Predicting Breast Pathological Complete Respons After Neoadjuvant Chemotherapy for Breast Cancer
NCT number | NCT03789851 |
Other study ID # | MIB001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2017 |
Est. completion date | June 1, 2020 |
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 NAC and targeted therapies, there has been dramatic improvement in
pCR rates, especially among triple-negative and human epidermal growth factor receptor 2
positive breast cancers. Rates of pCR in these groups of patients can reach 60% or higher.
NAC has significantly promoted the loco-regional de-escalating treatment of breast cancer,
and the need for breast surgery in NAC cases with pCR has been questioned, especially in
patients undergoing breast-conserving surgery with whole breast radiotherapy. The main
impediments for potential elimination of breast surgery have been the fact that conventional
and functional breast imaging techniques are incapable of accurate prediction of residual
disease. However, imaging-guided minimally invasive biopsy (MIB) techniques might have the
potential to overcome this impediment.
The investigators design and begin a prospective one-armed clinical study to explore the
accuracy of MIB in predicting breast pCR after NAC.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Country | Name | City | State |
---|---|---|---|
China | Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University | Jinan |
Lead Sponsor | Collaborator |
---|---|
Shandong Cancer Hospital and Institute |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | false negative CNB results,reported as the false negative rate (= FNR) | non-detected residual tumor by CNB (=index test) compared to breast surgery (=reference test): FNR = rate of patients with non-detected residual tumor by CNB compared to breast surgery Residual tumor is defined as a positive result; in surgical specimen as well as in CNB. | after breast surgery, up to 2 weeks after CNB | |
Secondary | negative predictive value (NPV) | The negative predictive value (NPV) will be calculated as the quotient of the number of cases with pCR in CNB and in surgical specimen (= true negative result), divided by the total number of cases with pCR in CNB. Residual tumor is defined as a positive result; in surgical specimen as well as in CNB. | after breast surgery, up to 2 weeks after CNB |
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