Ductal Carcinoma In Situ

14

Review clinical trials related to Ductal Carcinoma In Situ. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

Evaluation of Novel Iron-based Lymphatic Mapping Agent, Magtrace, for Delayed Sentinel Lymph Node Biopsy (SLNB) in Ductal Carcinoma In-Situ (DCIS)

The standard surgical approach for all patients undergoing mastectomy for the treatment of non-invasive, ductal carcinoma in situ (DCIS) is to perform axillary lymph node staging through use of a traditional sentinel lymph node biopsy (SLNB) procedure where the lymph nodes that drain the breast first are removed at the time of mastectomy. This recommendation for traditional SLNB is due to the risk of finding invasive cancer during surgical evaluation of the mastectomy specimen and the inability to accurately map the lymphatic channels once the breast is removed. In a study by Herremans et al, the majority of traditional SLNBs were demonstrated to be unnecessary. By using Magtrace, a novel iron based lymphatic mapping agent, a delayed SLNB could eliminate these unnecessary traditional SLNBs. Magtrace, or superparamagnetic oxide (SPIO), was developed in 2018. Unlike traditional mapping agents of blue dye and technetium that clear the body within 24-48 hours, Magtrace remains in the lymph nodes for at least 4 weeks. Magtrace's ability to remain in the lymph node allows accurate mapping of the lymph nodes at the time of the mastectomy with the ability to return to the operating room for a delayed sentinel lymph node biopsy if invasive cancer is found on final pathology. This study will investigate whether the use of Magtrace will successfully allow patients with DCIS undergoing mastectomy to avoid undergoing SLNB.

Participants needed: 30
Trial details
Phase: Phase 2Age: 18+Biological sex: AllType: InterventionalSponsor: University of FloridaUpdated: Jun 8, 2026Locations: 1
Eligibility criteria

Adults ≥ 18 years of age. [+4]

Patients with contralateral invasive breast cancer requiring traditional sentine... [+9]

Status: Recruiting

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease. Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Participants needed: 400
Trial details
Phase: Phase 2Age: 18+Biological sex: FemaleType: InterventionalSponsor: QuantumLeap Healthcare CollaborativeUpdated: May 22, 2026Locations: 28
Eligibility criteria

Patients with a diagnosis of hormone positive DCIS who have undergone surgery wi...

Status: Not yet recruiting

HISMAR: Intraoperative Margin Assessment Using the Histolog® Scanner to Reduce Reoperation in Breast-Conserving Surgery

This study evaluates whether systematic intraoperative margin assessment using the Histolog® Scanner - a confocal fluorescence microscopy device - reduces the need for reoperation after breast-conserving surgery (lumpectomy) in women with lobular carcinoma (ILC), ductal carcinoma in situ (DCIS), or invasive carcinoma with a DCIS component (NST+DCIS). After lumpectomy, the fresh specimen is imaged in real time by the surgeon using the Histolog® Scanner, which produces histological-quality images of the specimen surface without any tissue processing. This allows immediate assessment of surgical margins in the operating room, enabling the surgeon to perform additional tissue removal if needed before closing. Based on institutional data from 266 cases at CHVR (2021-2024), the current reoperation rate in this population is 11.3%. The study tests whether systematic use of the Histolog® Scanner in addition to standard care reduces this rate by 50% or more (to ≤5.6%). A total of 228 patients will be enrolled prospectively at the Centre Hospitalier du Valais Romand (CHVR), Sion, Switzerland. The reoperation decision is made by the multidisciplinary tumour board based on final histopathology results, independently of the intraoperative findings.

Participants needed: 228
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Hôpital du ValaisUpdated: Apr 14, 2026Locations: 1
Eligibility criteria

Female patient, aged 18 years or older at time of surgery. [+5]

Pregnancy (confirmed or suspected) at time of surgery. [+5]

Status: Not yet recruiting

CAN1012 in Pre-Malignant DCIS and LCIS

This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18+Biological sex: AllType: InterventionalSponsor: Providence Health & ServicesUpdated: Apr 8, 2026Locations: 1
Eligibility criteria

Male or female patients with DCIS or LCIS found on core biopsy. [+10]

Any serious underlying medical or psychiatric condition that, in the opinion of... [+9]

Status: Recruiting

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for Early-Stage Breast Cancer (H-ASSIST)

This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy. The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.

Participants needed: 90
Trial details
Phase: Phase 2Age: 50+Biological sex: FemaleType: InterventionalSponsor: UNC Lineberger Comprehensive Cancer CenterUpdated: Mar 30, 2026Locations: 1
Eligibility criteria

Willing and able to provide written informed consent obtained to participate in... [+5]

Receipt of concurrent breast reduction involving tissue rearrangement in the lum... [+7]

Status: Not yet recruiting

Breast Tumour Size Measurement by Field Cycling Imaging

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can accurately estimate tumour size in patients with a type of breast cancer called ductal carcinoma in situ (DCIS). The main question it aims to answer is: Can FCI accurately estimate DCIS lesion size compared with histology results? Participants will have a standard MRI scan and an FCI scan before undergoing surgery to remove the tumour.

Participants needed: 12
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: University of AberdeenUpdated: Mar 25, 2026Locations: 1
Eligibility criteria

Females ≥ 18 years old. [+5]

Subjects undergoing chemotherapy or hormonal therapy. [+3]

Status: Recruiting

EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.

Participants needed: 200
Trial details
Age: 18+Biological sex: FemaleType: ObservationalSponsor: Thomas Jefferson UniversityUpdated: Mar 17, 2026Locations: 1
Eligibility criteria

Female [+6]

Patient has started therapy or already had definitive oncologic surgery [+1]

Status: Recruiting

Prototype DAA/TAA Vaccine Targeting MUC1 for Immune Interception and Prevention in Ductal Carcinoma In Situ

Women with biopsy-proven ductal carcinoma in situ (DCIS) will be enrolled into two cohorts. One cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator (SERM) for about 12 weeks prior to surgery at 12 weeks. The second cohort will receive neoadjuvant therapy with an aromatase inhibitor or selective estrogen receptor modulator and MUC1 vaccination (MUC1 peptide + Hiltonol®) pre-operatively at baseline, and weeks 2 and 10, followed by surgery at about 12 weeks. Patients in the vaccine cohort will be offered an optional boost vaccine 6 months after surgery.

Participants needed: 50
Trial details
Phase: Phase 1Age: 18+Biological sex: FemaleType: InterventionalSponsor: Finn, Olivera, PhDUpdated: Mar 12, 2026Locations: 1
Eligibility criteria

Females, 18 years of age or older. Pre-menopausal women must use an effective me... [+18]

Invasive breast cancer > 1mm on pathologic evaluation [+15]

Status: Recruiting

Novel Cavity Marking Technique in Breast Cancer Patients Undergoing Breast Conservation Surgery With Oncoplastic Reconstruction for the Delivery of Adjuvant Radiotherapy and Accuracy of Recommended Re-excisions

This study will investigate a novel approach to marking surgical cavity margins following tumor resection, to allow for more accurate radiotherapy following oncoplastic surgery. Our proposed cavity marking schema will allow radiation oncology to identify the cavity margins more accurately on CT simulation for radiation planning and delivery. This cavity marking schema also provides more accurate margin identification in patients recommended for re-excision of close or positive margins.

Participants needed: 50
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of FloridaUpdated: Dec 15, 2025Locations: 1
Eligibility criteria

Adults ≥ 18 years of age. [+6]

Patient not recommended for, or have declined, adjuvant radiotherapy [+4]

Status: Recruiting

A Study of Disappearing Markers for Daily Radiation Treatment Delivery for Breast Cancer Patients.

The goal of this clinical trial is to learn if tattoos applied with Magic Ink is as safe as commercially available standard tattoo ink for the purpose of radiation in women with breast cancer undergoing radiation treatment. The main questions are: * Is the Magic Ink as safe as standard tattoo ink * Does Magic Ink continue to function and remain visible for radiation therapists during the treatment Participants will be consented and given a skin assessment. Once enrolled participants will be administered the Magic Ink tattoo instead of the standard tattoo ink in preparation for their radiation treatment. Participants will also complete a survey regarding body image. Skin assessment will occur again after the first week of radiation and at 3 months later. Throughout the radiation therapy the medical physicist will complete surveys about ease of set-up of the equipment.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Barbara Ann Karmanos Cancer InstituteUpdated: Sep 18, 2025Locations: 1
Eligibility criteria

Participant must have histologically or cytologically confirmed stage 0 ductal c... [+10]

Participants who have received prior radiation treatment to the affected breast. [+4]

Status: Recruiting

Preoperative Partial Breast Irradiation in Early-Stage Breast Cancer

In the management of early breast cancer patients, postoperative radiotherapy following breast-conserving surgery has been established as the standard treatment. Over the past two decades, significant changes have occurred in radiotherapy for breast cancer, encompassing dose fractionation methods, radiotherapy techniques, and delineation of the radiation field. Hypofractionated radiotherapy has been reported in numerous randomized phase 3 studies to show equivalent tumor control rates, reduced acute side effects, and similar late side effects compared to conventional fractionation. Among hypofractionated radiotherapy approaches, particularly in early-breast cancer, accelerated partial breast irradiation (APBI) may be chosen over whole breast irradiation (WBI). This approach is based on data indicating that the majority of local recurrences in breast cancer occur around the site of the primary tumor. By targeting radiation to the involved breast region, it becomes possible to increase the dose per fraction while shortening the overall treatment duration due to the smaller radiation treatment volume. While careful patient selection is crucial, multiple clinical studies have demonstrated that APBI, particularly after breast-conserving surgery, yields satisfactory local control rates comparable to WBI. This is accompanied by reduced side effects, improved convenience, enhanced quality of life, and potential cost savings. Traditionally, APBI has been administered after surgery, but there is a recent trend to explore preoperative APBI. The rationale for performing preoperative APBI includes several considerations. Firstly, compared to postoperative APBI, the precise location of visually identifiable tumors allows for more accurate and targeted radiation therapy, minimizing the impact on adjacent normal tissues and achieving superior cosmetic results. Secondly, reducing the size of the preoperative lesion may enable more conservative surgery, decreasing the extent of the surgical procedure. Thirdly, it can serve as a preparatory treatment to assess tumor responsiveness. Fourthly, in some cases, it may be administered for definitive purposes, especially in elderly or frail women who may find it challenging to undergo standard treatment due to concurrent health issues. Several clinical studies have reported the effectiveness and validity of preoperative PBI in a few cases of early breast cancer. These studies have shown low rates of acute and chronic toxicity, with excellent cosmetic outcomes. While accumulating evidence supports preoperative PBI, there is currently a lack of comparative studies with postoperative PBI. Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and postoperative PBI in early breast cancer patients.

Participants needed: 47
Trial details
Phase: Phase 2Age: 45+Biological sex: FemaleType: InterventionalSponsor: Yonsei UniversityUpdated: Nov 7, 2024Locations: 1
Eligibility criteria

Histologically confirmed ductal carcinoma in situ (DCIS) and invasive breast can... [+3]

cN+ [+8]

Status: Recruiting

Cryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ

Cryoablation or tumor freezing is a percutaneous, office-based procedure that is emerging as a minimally invasive, cost-effective alternative to surgery that is currently being evaluated in clinical trials for the management of for early-stage invasive breast cancer. The investigator will also evaluate the potential of cryoablation as a minimally invasive alternative to surgery for small areas of DCIS by examining its ability to achieve complete ablation of DCIS within the targeted cryoablation zone of necrosis.

Participants needed: 30
Trial details
Age: 18+Biological sex: FemaleType: InterventionalSponsor: Glendale Adventist Medical Center d/b/a Adventist Health GlendaleUpdated: Mar 3, 2023Locations: 1
Eligibility criteria

DCIS spanning 2 cm or less based on its radiographic appearance by mammography a... [+6]

Status: Recruiting

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Participants needed: 200
Trial details
Age: 50-100Biological sex: FemaleType: ObservationalSponsor: RPCR, Inc.Updated: Aug 5, 2022Locations: 2Duration: 5 Years
Eligibility criteria

Women 50 years or older [+10]

Lobular histology [+16]

Status: Recruiting

Impact of Neoadjuvant Hormonal Therapy on the Surgical Management of Extensive Ductal Carcinomas in Situ

Ductal carcinoma in situ (DCIS) accounts for approximately 20% of newly diagnosed breast cancer cases. Of these women, 20% require radical management in the form of mastectomy because of the extent of the lesions, which most often manifest as diffuse microcalcifications. This mutilating surgical management contrasts with the excellent prognosis of this pathology and considerably alters the quality of life of patients. Neoadjuvant hormone therapy has shown its efficacy in hormone-dependent infiltrating ductal carcinomas and offers the possibility of conservative surgery after hormone therapy. Adjuvant hormone therapy with Tamoxifen or anti-aromatase drugs has shown its efficacy in the prevention of homo or contralateral recurrence. The HORNEO 01 trial fits perfectly in the current context of surgical de-escalation of ductal carcinomas in situ. The objective of the study is to evaluate the impact of neoadjuvant hormone therapy on the surgical management of extensive DCIS.

Participants needed: 262
Trial details
Phase: Phase 2Age: 40+Biological sex: FemaleType: InterventionalSponsor: Institut Cancerologie de l'OuestUpdated: Apr 22, 2022Locations: 8
Eligibility criteria

Patient ≥ 40 years old [+8]

Invasive breast carcinoma [+14]