Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Breast Neoplasms

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Diseases

Skin Diseases

Wide excision of DCIS; no radiotherapy (RT).

Wide excision of DCIS and a minimum of 1cm histologically negative margin of breast tissue

Observation

Julia Wong, MD

The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

* Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.
* Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.

Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

Wide Excision Alone for DCIS-Grades 1 and 2

Using information gathered from follow-up physical examinations and mammography to check for recurrence (DCIS or invasive carcinoma in the breast), DCIS patients treated with wide excision alone will be evaluated.

Using information gathered from follow-up physical examinations and mammography, the exploration of breast recurrences between grade 2 DCIS and grade 1 DCIS patients will be evaluated.

Brigham and Women's Hospital

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute

Principal Investigator

Symptoms and General Pathology

Pathologic Complete Response

Ultrasound-guided core needle biopsy (14G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.

Vacuum-assisted biopsy (10G, ≥5 cores recommended) for complete clinical response (cCR) or near-cCR predicted by MRI.

Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.

Minimally-invasive biopsy

Surgical wide excision of the biopsied area.

wide excision

Wonshik Han, MD, PhD

The purpose of this study is to evaluate the ability of preoperative biopsy to predict correctly pathologic complete response in breast cancer patients with complete clinical response after neoadjuvant chemotherapy.

Breast cancer patients who received neoadjuvant chemotherapy and is predicted to have achieved pathologic complete response (pCR) on MRI will enrolled. The enrolled patients will undergo either US-guided multiple core needle biopsy or US-guided vacuum-assisted biopsy of the tumor bed where it had been marked with an indicator (clip). The patient will undergo subsequent wide excision of the tumor bed. Histopathologic findings of the biopsy and the surgical specimen will be compared for pCR, and the ability of preoperative biopsies to predict pCR will be evaluated.

Comparison of pathological findings for residual tumor between minimally-invasive biopsy procedure and subsequent wide excision of the biopsied area

Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.

Prediction of Pathologic Complete Response by Multiple Core Needle Biopsy or Vacuum Assisted Biopsy Before Surgery in Breast Cancer With Complete Clinical Response After Neoadjuvant Chemotherapy.

IPD including study protocol, informed consent form, clinical study report and analytic code will be shared.

Percentage of participants with pathologic complete response (pCR) confirmed by surgical excision in patients predicted by biopsy to have pCR

Seoul National University Hospital

Professor

Core Needle Biopsy

Vacuum-assisted Biopsy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Asian

Race/Ethnicity, Customized

South Korea

Region of Enrollment

Maximum tumor size on imaging in mm before neoadjuvant chemotherapy

Tumor size before neoadjuvant chemotherapy

Dr. Wonshik Han

Ultrasound-guided core needle biopsy + vacuum-assisted biopsy

Number of participants with no tumor on biopsy

Negative Predictive Value

False Negative Rate

Image-guided core needle biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.

The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively.

Image-guided vacuum-assisted biopsy (14G, ≥5 cores recommeded) for complete clinical response (cCR) or near-cCR predicted by MRI.

The patients were assigned to either core needle biopsy or vacuum-assisted biopsy alternatively.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast	NCT00165256	Ductal Carcinom...	Observation	18 Years -	Dana-Farber Cancer Institute
Prediction of pCR by Preoperative Biopsy in Breast Cancer With cCR After Neoadjuvant Chemotherapy.	NCT03273426	Breast Neoplasm	Minimally-invas... wide excision	18 Years - 80 Years	Seoul National University Hospital

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