Minimally Invasive Biopsy Predicting Breast pCR After NAC for Breast Cancer

NCT03789851 | Unknown

• 1 other identifier: MIB001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• negative predictive value (NPV)

  after breast surgery, up to 2 weeks after CNB

Study Arms (1)

core needle biopsy

EXPERIMENTAL

All patients enrolled in this study received a ultrasound-guided multipoint core needle biopsy after surgery.

Device: core needle biopsy

Interventions

core needle biopsy DEVICE

Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.

Also known as: ultrasound-guided multipoint core needle biopsy

core needle biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• In case of multicentric disease: confirmation of the same tumorbiological subtype defined by immunohistology in at least 2 lesions.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University

Jinan, 250117, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Central Study Contacts

Yong-sheng Wang

CONTACT

+86 0531-67626213; wangysh2008@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Breast Cancer Center

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 31, 2018
• Study Start: June 1, 2017
• Primary Completion: June 15, 2019
• Study Completion: June 1, 2020
• Last Updated: December 31, 2018

Record last verified: 2018-12

Locations

CN (1)