Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Accelerated Partial Breast Irradiation using Mammosite RTS

Accelerated partial breast irradiation using IMRT planning technique of external beam radiotherapy

Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.

Breast Brachytherapy with Mammosite RTS

Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation

Intensity Modulated Radiotherapy

Dennis Carter, MD

Accelerated Partial Breast Irradiation by Mammosite and intensity modulated radiotherapy is safe and effective in patients with early stage breast cancer resected by lumpectomy.

Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy

A Phase II Study of Accelerated Partial Breast Radiotherapy With Either a Novel Breast Brachytherapy Technique - Mammosite or Intensity Modulated Radiotherapy

Charles Leonard, MD

Rocky Mountain Cancer Centers

Dennis Carter, MD, Principle Investigator

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Carcinoma In Situ

The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.

MammoSite Radiation Therapy System

Oscar Streeter, MD

This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.

Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).

MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ

MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)

Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.

As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint

University of Southern California

Hologic, Inc.

Enrolled subjects with MammoSite device placed

Intent to Treat

Subjects enrolled with device placed and treated with partial breast irradiation

Treated

Age, Categorical

Age Continuous

Sex: Female, Male

United States

Region of Enrollment

Nancy Chenette, Director, Clinical Affairs

Local Control Rate for Follow-up Period of 5 Years.

Overall Survival

Cause Specific Survival

Disease Free Survival

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years

Excellent

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years

Good

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years

Fair

Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years

Poor

Subjects with Cosmetic Evaluation at 5 Years

Cosmetic Evaluations Over Time

Women with DCIS who were willing to enroll and consented

Enrolled

Enrollment to Device Placement-Enrolled

Device Placed toTreatment-ITT

Treated Through 5-yr Follow Up-Treated

Registry

Deborah Fang, MD

A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.

The data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.

PURPOSE OF STUDY

The patient understand that she has cancer of the breast. The patient understand that is offered the opportunity to participate in a registry study to collect data on the FDA approved device,Partial Breast Brachytherapy Applicator. Partial Breast Brachytherapy is a treatment method that works by delivering radiation from inside the breast directly to the tissue where cancer is most likely to recur. The Partial Breast Brachytherapy Applicator is a device that has tiny catheters or wires that fit inside the lumpectomy cavity (the space left after the tumor is removed). Radioactive sources (seed) are placed within the device by a computer controlled machine. This radioactive source will deliver the radiation therapy to the breast

A registry is an observation database. Participation in this registry does not require any additional or different procedures or drugs other than those you would normally receive for breast cancer. Registry databases are used to identify trends in medical care that help the medical community identify optimal care for different diseases.

PROCEDURES

If the patient agree to take part in this registry, data will be compiled on the safety and performance of the Partial Breast Brachytherapy Applicator based on the information collected about the treatment and follow up visits.

POTENTIAL RISKS AND DISCOMFORTS

There is no medical risk to the patient if she takes part in this registry, as she will continue to receive the same medical care as provided by her medical team.

POTENTIAL BENEFITS:

It is not possible to state that the patient will benefit from this study. The information obtained from study may be used scientifically and may possibly be helpful to others.

ALTERNATIVES TO TREATMENT

The patient participation is voluntary and she may choose not to participate in this study or she may stop at any time. The patient choice will not affect doctors from providing care. The patient will not lose any benefits if she choose not to participate or if you withdraw from this study. She is free to seek care from a doctor of her choice at any time.

A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.

The efficacy of the treatment will be measured by using the overall survival. The following endpoints will also be reported and analyzed:Disease Free Survival, Cause Specific Survival, Ipsilateral Breast Failure, Contralateral Breast Failure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accelerated Partial Breast Radiotherapy With Either Mammosite or Intensity Modulated Radiotherapy	NCT01185145	Breast Cancer	Breast Brachyth... Intensity Modul...	40 Years -	Rocky Mountain Cancer Centers
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ	NCT00586326	DCIS	MammoSite Radia...	45 Years -	Hologic, Inc.
A Single Site Prospective, Non-randomized Study of Partial Breast Intracavitary Brachytherapy Devices to Evaluate Local Tumor Control, Cosmetic Outcome and Toxicities.	NCT01813825	This Study Has ...	Registry	45 Years -	St Vincent's Hospital

Spots Global Cancer Trial Database for mammosite

Every month we try and update this database with for mammosite cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for mammosite

Every month we try and update this database with for mammosite cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for mammosite cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.