Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Breast Neoplasms

Breast Carcinoma In Situ

Carcinoma in Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Other Dietary Supplements

Metformin

Biguanides

Omega 3 Fatty Acid

Open Label- Metformin and Omega-3 fatty acids for 12 months post baseline data collection.

Metformin 850mg, oral, twice a day for 12 months

Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months

Omega-3 fatty acids

Katherine Crew, MD, MS

The purpose of this study is to determine whether it is feasible to give a combination of Metformin and omega-3 fatty acids for one year to women with a history of early stage breast cancer. We will also evaluate whether the metformin and omega-3 fatty acids combination causes changes in breast tissue, blood, and mammograms.

Metformin is a medication used to treat and prevent diabetes and omega-3 fatty acids has been shown to lower cholesterol and improve cardiovascular health. Research has shown that Metformin and omega-3 fatty acids may also be effective in preventing cancer. In this study, we want to find out what effects, good and/or bad, the Metformin and omega-3 fatty acids combination has on you and your risk of developing a new breast cancer.

Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

Pilot Biomarker Modulation Study of Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer

The primary objective is to assess the safety and feasibility of a one-year intervention of metformin and omega-3 fatty acids in early stage breast cancer patients who completed adjuvant treatment.

Determine the efficacy of these drug interventions in reducing mammographic density

Determine the efficacy of these drug interventions in modulating markers of insulin signaling.

Determine the efficacy of these drug interventions in modulating metabolic profile markers.

Determine the efficacy of these drug interventions in modulating inflammatory markers.

Determine the efficacy of these drug interventions in modulating anthropometric measures.

Katherine D. Crew

Assistant Professor of Medicine and Epidemiology

Carcinoma, Lobular

Adenocarcinoma

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure.

Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.

Intraoperative Radiotherapy

Lawrence Wagman, M.D.

This clinical trial is being conducted to find out the effects (good and bad) of giving the full radiation treatment for breast cancer as a single dose of radiation during surgery for breast cancer. This single fraction intraoperative radiotherapy with electrons will study the toxicity, local control and cosmetic outcome.

For patients with certain types of breast cancer, one standard treatment is breast conserving surgery or lumpectomy (surgery to remove abnormal tissue or cancer from the breast and a small amount of normal tissue around it) followed by breast radiation. The radiation treatment in this situation usually lasts 3 to 5 1/2 weeks followed by 5-8 daily localized irradiation (or boost) treatments at the site where the lump was removed. During this study, the single dose of electron irradiation given at the surgical site during the operation will replace the radiation given after surgery.

Single Fraction Intraoperative Radiotherapy

Single Fraction Intraoperative Radiotherapy With Electrons: An Option in Breast-Conserving Operable Breast Cancer Stages 0, I and II - Prospective, Single-arm Trial

Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - system:

* End of initial surgical phase: Week 1, 4
* First Follow-up investigation: Month 2 Assessment of late toxicity according to NSABP scoring-systems at 6, 12, 24, 36, 48, and 60 months

Assessment of cosmetic outcome according to 5-point scoring system

* Week 1, 2; Month 2, 6, 12, 24, 36, 48, 60
* At yearly follow-up (photodocumentation in standardized positions) for 5 years

Recurrence is assessed at month 6, 12, 24, 36, 48, 60

St. Joseph Hospital of Orange

Carcinoma, Ductal, Breast

Carcinoma, Ductal

Intraoperative electron radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on a mobile self-shielded magnetron-driven X-band linear accelerator specifically developed for use in the operating room. This machine produces megavoltage electron beams of energy ranging between 4 and 12 MeV. The radiation is delivered from the device to the tumor bed through an attached applicator. A single dose of 21 Gy calculated to the 90% depth posterior to the tumor bed will be administered and will last approximately 2.5 minutes.

Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.

Intraoperative Electron Radiotherapy

Barbara Krueger, MD FACS

The overall objective of this study is to determine the feasibility and tolerability of single dose Intraoperative Electron Radiation Treatment ("IOERT") as definitive therapy when administered at the time of breast conserving surgery for patients with early stage breast cancer.

Evaluate local and distant recurrence rates and cosmetic outcomes. Both clinical evaluation of cosmetic outcome by the Surgeon, and subjective impression of cosmetic outcome by the patient, are evaluated using questionnaire.

Local recurrence is evaluated under the same imaging protocol used for Whole breast radiation.

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)

Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT) As A Single, Full Dose Partial Breast Irradiation For Early Stage, Node Negative, Invasive Breast Cancer

Subjects will be followed for recurrence rates at one month, three months, six months, twelve months, and then annually for up to 10 years. This will include: history and physical exam, as well as radiographic images at physician discretion and per study protocol.

Assessment of the overall patient satisfaction related to the therapy and cosmetic outcome. Cosmesis will be scored by both the physician and patient using the RTOG cosmesis rating system at one month, three months, six months, twelve months, and 24 months. The secondary outcome measure will only take place in the first two years of the 10 year time frame for patient follow up. After 24 month evaluations, patients will only be followed for incidence of local and distance recurrence rates.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Metformin and Omega-3 Fatty Acids in Woman With a History of Early Stage Breast Cancer	NCT02278965	Stage 0 Breast ... Breast Neoplasm... Stage I Breast ... Stage II Breast... Stage III Breas...	Metformin Omega-3 fatty a...	21 Years - 75 Years	Columbia University
Single Fraction Intraoperative Radiotherapy	NCT01688388	Invasive Ductal... Stage 0 Breast ... Stage I Breast ... Stage II Breast...	Intraoperative ...	41 Years - 90 Years	St. Joseph Hospital of Orange
Lumpectomy Followed By Intraoperative Electron Radiation Therapy (IOERT)	NCT01960803	Invasive Ductal... Carcinoma Breas...	Intraoperative ...	50 Years - 95 Years	Advocate Health Care

Spots Global Cancer Trial Database for stage i breast carcinoma