Phase 2 Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma

Trial ID or NCT#

NCT03909282

Status

recruiting iconRECRUITING

Purpose

The purpose of this pilot study is to compare by pathological findings surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision of ductal carcinoma in situ (DCIS)

Official Title

A Randomized Phase 2 Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable, image-detected breast abnormality - Signed and dated IRB-approved written informed consent - Mammographic or MRI non-mass lesion (calcifications, non-mass enhancement on MRI) measuring 4 cm or less in greatest dimension - Estrogen receptor positive or negative, progesterone receptor positive or negative DCIS; HER2 positive, negative or unknown DCIS is allowed. - Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging and evidence of residual radiographic abnormality. The post-biopsy mammogram must be performed within 6 weeks of randomization date - Placement of Savi scout optical reflectance marker in tumor bed area as a wireless guide for surgery and for neoRT treatment planning is preferred but not required if anatomic landmarks are sufficient for radiation planning. If required, then placement occurs before treatment is initiated (surgery or neoRT), but not necessarily before randomization. If anatomic landmarks are used for arm 2, then needle or wireless devices are allowable for surgical preoperative targeting. - Planned lumpectomy. Mastectomy will be acceptable if lumpectomy fails by virtue of involved margins or size of lesion, or patient chooses this approach after randomization - Review of imaging studies by Radiation Oncologist to ascertain feasibility of PBI prior to randomization - based on their estimation that 30% or less of the breast volume will be encompassed in the radiation fields. - Patients who had a prior contralateral invasive or non-invasive (DCIS) cancer are eligible - ECOG performance status 0, 1, or 2 Protocol Version #9 19 March 18, 2021 - Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or contralateral breast are allowed
Exclusion Criteria:
  1. - Invasive carcinoma on core needle biopsy, including microinvasive carcinoma - Radiographic extent of DCIS >4.0 cm - Mass lesion on breast imaging or palpable tumor - No residual radiographic lesion after diagnostic percutaneous core needle biopsy - Prior history of ipsilateral invasive or noninvasive breast cancer - Pregnant or breastfeeding - Prior ipsilateral breast or chest irradiation - Multicentric or multifocal DCIS - Synchronous contralateral invasive or non-invasive breast cancer - Pagets' disease of the breast - Active collagen vascular disease - Positive axillary lymph nodes - Not meeting the described criteria for partial breast irradiation during initial clinical evaluation - Psychiatric or addictive disorders or other condition, that, in the opinion of the investigator, would preclude the patient form meeting the study requirements or interfere with the interpretation of study results - Endocrine therapy is not allowed prior to surgery unless continued for a contralateral cancer
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Investigator(s)

Irene Wapnir, MD
Irene Wapnir, MD
Surgical oncologist, Breast surgeon, Breast specialist
Professor of Surgery (General Surgery)

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Contact

Sinyoung Park
650-721-4485

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View on ClinicalTrials.gov