BridgeMD
Compares treatment options for Ductal Breast Carcinoma in Situ
Official title Surgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma
ClinicalTrials.gov ID: NCT03909282
What this study is testing
- What it's testing
- 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)
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.