An interventional study of Lumpectomy and Partial breast irradiation prior to surgery in Ductal Breast Carcinoma in Situ, sponsored by Stanford University. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Stanford University · Not applicable, Interventional, and Treatment
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)
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.
285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Surgical excision of ductal carcinoma
Procedure: Lumpectomy
Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.
Procedure: Lumpectomy · Radiation: Partial breast irradiation prior to surgery
Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
Also known as: Mastectomy
Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
A DCIS pathologic complete response will be defined as the absence of in situ carcinoma in the surgical resection specimen. The rate of DCIS pathologic complete response (pCR) will be calculated for Arm 1 and Arm 2.
Time frame: 12 weeks
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)
Molecular subtypes based on gene expression profiling with therapy response will be corelated. • DCIS subtypes will be defined based on grade, estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) status as follows: * Low/intermediate grade versus high grade * ER/PR-negative versus ER/PR-positive * HER2-positive versus HER2-negative
Time frame: 12 weeks
Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Tumor grade (grade 1, 2, 3) will be compared pre- and post-therapy.
Time frame: 12 weeks
Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Degree of nuclear atypia (low, intermediate, high) will be compared pre- and post-therapy.
Time frame: 12 weeks
Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Percent tumor necrosis (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Time frame: 12 weeks
Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Tumor cellularity (0-100%) will be quantified on the basis of percentage of overall residual tumor area and compared pre- and post-treatment.
Time frame: 12 weeks
Proportion of subjects experiencing a wound complication on Arm 1 compared to Arm 2
Wound complications and healing will be monitored in both arms.The following events will be considered wound complications: wound dehiscence, hematoma requiring intervention, seroma requiring drainage, skin necrosis requiring resection, cellulitis requiring antibiotic therapy.
Time frame: 12 weeks
Correlation of post-radiation imaging characteristics with pathologic findings
Mammography obtained prior to surgical resection in Arm 2 patients will be assessed for the presence or absence of a residual mammographic abnormality, the size in mm of the residual mammographic abnormality and the longest span in mm of residual calcification and will be compared to the pathologic presence or absence of residual tumor, size in mm of the pathologic residual DCIS and whether the residual calcification is associated with pathologic residual DCIS.
Time frame: 12 weeks
Rate of invasive carcinoma comparison in Arm 1 to Arm 2
Rate of pathologic residual invasive carcinoma will be assessed in Arm 1 and Arm 2.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Carcinoma, Intraductal, Noninfiltrating →