Ductal Breast Carcinoma in SituNORDISNCT03909282
Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
A study testing Lumpectomy and Partial breast irradiation prior to surgery in people with Ductal Breast Carcinoma in Situ, run by Stanford University at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma in Situ
- What is being tested?
- Lumpectomy and Partial breast irradiation prior to surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2019to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford University
Stanford, California, 94304
Vishal Joshi, 650-725-7489, vishalj4@stanford.edu
Irene Wapnir, MD
About this study
Official title: A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
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)
Read the detailed 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.
- Conditions
- Ductal Breast Carcinoma in Situ
- Being tested
- Lumpectomy, Partial breast irradiation prior to surgery
- Keywords
- Ductal Breast Carcinoma
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumpectomyProcedure or surgery
Also called Mastectomy
Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
Partial breast irradiation prior to surgeryRadiation
Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
| Study group | Role | What they receive |
|---|---|---|
| Surgical Excision | Active comparator | Surgical excision of ductal carcinoma Receives: Procedure: Lumpectomy |
| Neoadjuvant partial breast irradiation | Experimental | Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy. Receives: Procedure: Lumpectomy; Radiation: Partial breast irradiation prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (8)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start22 Mar 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Breast Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irene Wapnir, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909282
- Sponsor's protocol ID
- IRB-46373
- Other IDs
- BRS0096, NCI-2019-02516
- Acronym
- NORDIS
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2019
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Comparing Surgical Excision Versus Neoadjuvant Radiotherapy Followed by Delayed Surgical Excision of Ductal Carcinoma In Situ (NORDIS)
- ClinicalTrials.gov ID
- NCT03909282
- Acronym / sponsor ID
- NORDIS / IRB-46373
- Conditions
- Ductal Breast Carcinoma in Situ
- Keywords
- Ductal Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 22 Mar 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical Excision | Active comparator | Procedure: LumpectomySurgical excision of ductal carcinoma |
| Neoadjuvant partial breast irradiation | Experimental | Procedure: Lumpectomy, Radiation: Partial breast irradiation prior to surgeryPartial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LumpectomyAlso: MastectomyStandard of Care surgery for DCIS (either lumpectomy or mastectomy) | Procedure or surgery | Neoadjuvant partial breast irradiation, Surgical Excision |
| Partial breast irradiation prior to surgeryPartial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant) | Radiation | Neoadjuvant partial breast irradiation |
Primary outcome
Rate of ductal carcinoma in situ (DCIS) pathologic complete response
Time frame: 12 weeks
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.
8 secondary outcomes
Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)
Time frame: 12 weeks
Tumor grade comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Percent tumor necrosis comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Tumor cellularity comparison of radiation-induced treatment effect pathologically pre- versus post-therapy
Time frame: 12 weeks
Proportion of subjects experiencing a wound complication on Arm 1 compared to Arm 2
Time frame: 12 weeks
Correlation of post-radiation imaging characteristics with pathologic findings
Time frame: 12 weeks
Rate of invasive carcinoma comparison in Arm 1 to Arm 2
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irene Wapnir, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lumpectomy and Partial breast irradiation prior to surgery in people with Ductal Breast Carcinoma in Situ, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vishal Joshi (650-725-7489, vishalj4@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ductal carcinoma in situ (DCIS) pathologic complete response (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.