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Ductal Carcinoma In Situ clinical trials

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NCT ID: NCT02121873 Completed - Breast Cancer Clinical Trials

The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage

Start date: July 2011
Phase:
Study type: Observational

The objective of this study is to determine whether we can use minimally invasive techniques to gain access to exfoliated ductal epithelial cells for whole genome sequencing. 1. To examine women with nipple aspiration, ductoscopy and ductal lavage and collect exfoliated cells from two ducts per woman. 2. To collect a blood sample at the time of the examination in order to obtain the woman's baseline genomic sequence. 3. De-identified samples will then have DNA and RNA extracted and whole genome sequencing and transcriptome analysis performed by Covance and Illumina. 4. Comparisons will be made within a breast (two ducts) and between the duct and blood as well as between women.

NCT ID: NCT01815476 Completed - Clinical trials for Invasive Breast Cancer

The Prone Breast Radiation Therapy Trial

Start date: May 4, 2013
Phase: N/A
Study type: Interventional

Participants undergoing radiation after breast conserving surgery for an early breast cancer (either Ductal Carcinoma In Situ (DCIS), or Early Stage Invasive breast cancer), and are at increased risk of developing a skin reaction because of their large breast size. After breast conserving surgery (also known as a 'lumpectomy'), women with either DCIS or early stage invasive breast cancer receive radiation to the breast to decrease the risk of cancer recurrence. Breast radiation is usually done with women lying on their back ("supine"). Some women develop temporary breakdown of the skin (moist desquamation). This skin reaction can be painful and has been linked to long term side effects such as chronic pain and decreased quality of life. This study is being done because women with large breasts have higher rates of skin breakdown (called 'moist desquamation') and breast pain during and shortly after radiation therapy is complete. It is unclear if such skin reactions and pain would be improved by alternating treatment position - namely lying on your belly ("prone") during their radiation treatment.

NCT ID: NCT01644669 Active, not recruiting - Clinical trials for Ductal Carcinoma in Situ

Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®

Start date: May 8, 2012
Phase: N/A
Study type: Interventional

The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.

NCT ID: NCT01628536 Completed - Clinical trials for Ductal Carcinoma in Situ

A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ

Start date: June 2012
Phase: N/A
Study type: Interventional

The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.

NCT ID: NCT01448447 Completed - Breast Cancer Clinical Trials

Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®

Mammosite ML
Start date: December 2009
Phase: N/A
Study type: Interventional

This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS. Hypotheses: - For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates. - Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy. - Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.

NCT ID: NCT01391039 Terminated - Clinical trials for Ductal Carcinoma In-situ

Diagnostic Study of Early Breast Cancer Using Ultrasound

Start date: September 2011
Phase: N/A
Study type: Interventional

This is a pilot study designed to investigate new techniques to guide the appropriate diagnosis and treatment of Ductal Carcinoma In-situ (DCIS). The microvascularity and stiffness of the lesion may be prognostic factors that can guide the need for more or less extensive therapy or perhaps only imaging follow-up may be needed.

NCT ID: NCT01372618 Terminated - Clinical trials for Ductal Carcinoma in Situ

Breast Cancer Chemoprevention by SOM230, an IGF-I Action Inhibitor

Start date: June 2011
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a proof of principle clinical trial to evaluate the use of pasireotide (SOM230) in women with ductal carcinoma in situ (DCIS) of the breast. Surgery and radiotherapy are used as treatment for DCIS and subsequent treatment with antiestrogens has been effective in reducing the occurrence of invasive breast cancer. Unfortunately, treatment with antiestrogens carries potential serious side effects and toxicities that are intolerable to some patients. Preliminary data suggest that inhibition of IGF-1 action in the breast will be at least as effective as tamoxifen. Pasireotide is a somatostatin analog that prevents mammary development by inhibiting IGF-1 action directly in the mammary gland and also indirectly without causing menopausal symptoms. This study is an expansion of work that we have previously done in women with atypical hyperplasia of the breast, which showed that treatment with pasireotide for 10 days caused a reduction in the cellularity of these precancerous lesions. In our present study, women with DCIS will be treated with pasireotide for 20 days prior to surgical excision. Endpoints will be as follows: 1. To determine whether pasireotide will inhibit cell proliferation and angiogenesis (signs of tumor growth), and stimulate apoptosis (cell death) in surgically excised tissue in comparison to core biopsies from women with estrogen receptor (ER) positive DCIS. Both the core biopsy and surgical excision are standard of care procedures that women with DCIS have regardless of participation in this trial. 2. To use dynamic contrast enhanced MRI to assess patients before and after treatment with pasireotide and evaluate for changes in tumor volume and other tumor related features 3. In our previous study we found that many women experienced a slight elevation in blood sugar with 10 days of treatment with pasireotide. Other work has shown that this effect often resolves with greater duration of treatment. We are therefore expanding the duration of treatment in this study to 20 days to assess if the initial hyperglycemia seen with pasireotide improves as treatment duration progresses.

NCT ID: NCT01194440 Completed - Clinical trials for Stage IIIA Breast Cancer

Zoledronic Acid in Aromatase Inhibitor Induced Musculoskeletal Symptoms

Start date: February 2011
Phase: Phase 2
Study type: Interventional

RATIONALE: Zoledronic acid may prevent bone loss and help prevent or lessen musculoskeletal symptoms in women receiving hormone therapy for breast cancer. PURPOSE: This phase II trial is studying how well zoledronic acid works in preventing musculoskeletal symptoms in post-menopausal women with stage I, stage II, or stage III breast cancer receiving letrozole.

NCT ID: NCT01138553 Terminated - Clinical trials for Invasive Breast Cancer

Preoperative Testing of the Anti-Progesterone Mifepristone in Early Stage Breast Cancer

Start date: June 2010
Phase: Early Phase 1
Study type: Interventional

The primary objective of this study is to identify the group of women with early stage breast cancer most likely to benefit from treatment with the selective progesterone receptor modulator (SPRM) mifepristone. This will be done by treating women briefly prior to planned surgery and examining the decrease in growth rate (measured by Ki-67 immunohistochemistry) in tumor samples taken before and after exposure to mifepristone.

NCT ID: NCT01060345 Terminated - Clinical trials for Ductal Carcinoma in Situ

A Pilot Study of Chemo-prevention of Green Tea in Women With Ductal Carcinoma in Situ

Start date: May 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find molecular signs (biomarkers) to better understand the role of green tea as an anti-cancer and anti-inflammation agent in women with newly-diagnosed ductal carcinoma in situ (DCIS).