NCT03909282 Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
| NCT ID | NCT03909282 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Ductal Breast Carcinoma in Situ |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2019-03-22 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2019-03-22 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Inclusion Criteria * Core needle biopsy demonstrating DCIS (ductal carcinoma in situ) of non-palpable, image-detected breast abnormality * Signed and dated IRB-approved written informed consent * Women 18 years of age or older * Mammographic calcifications or MRI non-mass enhancement measuring 4 cm or less in greatest dimension, including multifocal disease * Estrogen receptor positive or negative, progesterone receptor positive, negative or unknown; HER2 positive, negative or unknown DCIS is allowed * Diagnostic needle biopsy within 16 weeks of randomization * Patients must have a biopsy marker placed within the tumor bed confirmed on post biopsy imaging. * 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 metallic markers are sufficient for radiation planning. Placement does not have to occur before randomization. Additionally, wire localization before surgery is permissible. * 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 * 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 * Concurrent foci of atypia or lobular carcinoma in situ in the ipsilateral or contralateral breast are allowed Exclusion Criteria * 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, if extent is \> 4cm * Synchronous contralateral invasive or noninvasive 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 from meeting the study requirements or interfere with the interpretation of study results * Endocrine therapy is not allowed from the time of study randomization to the completion of surgery unless the endocrine therapy is being continued for a contralateral cancer
Contact & Investigator
Irene Wapnir, MD
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT03909282 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ductal Breast Carcinoma in Situ. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03909282 currently recruiting?
Yes, NCT03909282 is actively recruiting participants. Contact the research team at vishalj4@stanford.edu for enrollment information.
Where is the NCT03909282 trial being conducted?
This trial is being conducted at Stanford, United States.
Who is sponsoring the NCT03909282 clinical trial?
NCT03909282 is sponsored by Stanford University. The principal investigator is Irene Wapnir, MD at Stanford University. The trial plans to enroll 50 participants.