Breast Cancer Clinical Trial

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

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)

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Full Description

There will be measurable histopathological treatment effects identified in Arm 2 cases receiving pre-operative radiation. Results found are expected to assist in designing a more definitive study. Compare pathological findings in individuals with ductal carcinoma in situ (DCIS) who have surgical excision versus neoadjuvant radiotherapy followed by delayed surgical excision.

It is noted that "phase 2" is formally associated with drug studies. Nonetheless, it is however part of the time of this study.

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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
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:

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

Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT03909282

Recruitment Status:

Recruiting

Sponsor:

Stanford University

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There is 1 Location for this study

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Stanford University
Stanford California, 94304, United States More Info
Sinyoung Park
Contact
650-721-4485
[email protected]
Irene Wapnir, MD
Principal Investigator

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Study is for people with:

Breast Cancer

Estimated Enrollment:

50

Study ID:

NCT03909282

Recruitment Status:

Recruiting

Sponsor:


Stanford University

How clear is this clinincal trial information?

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