Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer - Full Text View

Sponsor:	Massachusetts General Hospital
Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Beth Israel Deaconess Medical Center Boston Medical Center
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00694577

Purpose

The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.

Condition	Intervention	Phase
Ductal Breast Cancer	Radiation: Partial Breast Irradiation	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

To evaluate the feasibility of PBI directed XRT in selected stages 0 and 1 female breast cancer patients within each dose level. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the rate and severity of cutaneous toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
To evaluate the risk of breast fibrosis and fat necrosis [ Time Frame: 10 years ] [ Designated as safety issue: No ]
To evaluate cosmetic outcome [ Time Frame: 10 years ] [ Designated as safety issue: No ]
To evaluate patient satisfaction [ Time Frame: 10 years ] [ Designated as safety issue: No ]
To evaluate local and distant control rates [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2003
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental Study Participants 1-100	Radiation: Partial Breast Irradiation 32 Gy-8 Treatments, 4 Treatment Days
Group 2: Experimental Study Participants 101-200	Radiation: Partial Breast Irradiation 36 Gy- 9 Treatments, 4 1/2 Treatment Days
Group 3: Experimental Study Participants 201-400	Radiation: Partial Breast Irradiation 40 Gy-10 Treatments, 5 Treatment days

Detailed Description:

In this study, radiotherapy is given only to a portion of the breast around the tumor bed using external radiation treatments. This approach is called "partial breast irradiation".
Participants will undergo a planning session for the radiation treatments. This planning will be done by CT scan days or weeks before the start of treatment. This planning process is the same as that used to plan conventional radiation therapy treatments.
Radiation therapy will begin 4-12 weeks after the last surgery of the breast in individuals not receiving chemotherapy first. For individuals receiving chemotherapy before radiation therapy, radiation therapy will start 2-6 weeks after ending chemotherapy.
We will be studying three levels of radiation doses to see which is best. The dose the participant receives will depend upon when they are enrolled on the trial.
Participants will receive radiation treatment twice each day for 4 or 5 treatment days, with an overall treatment time of one week.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen.
Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT
18 years of age or older
ECOG Performance Status 0
Required laboratory data as outlined in the protocol

Exclusion Criteria:

Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue
Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region
Tumor > 2.0cm, nodal involvement, or metastatic involvement
Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma
Known mutation carrier, including BRCA1 and BRCA2
History of cosmetic or reconstructive breast surgery
Psychiatric illness which would prevent the patient from giving informed consent
Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease
Participants with a "currently active" second malignancy other than non-melanoma skin cancers
Patients with diffuse (> 1 quadrant or >5cm) suspicious microcalcifications
Women who are pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00694577

Contacts

Contact: Alphonse Taghian, MD, PhD

617-726-6050

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02214
Principal Investigator: Alphonse Taghian, MD, PhD
Dana-Farber Cancer Institute	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jay Harris, MD
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Abram Recht, MD
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Lisa Kachnic, MD 617-638-7070

Sponsors and Collaborators

Massachusetts General Hospital

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Boston Medical Center

Investigators

Principal Investigator:

Alphonse Taghian, MD, PhD

Massachusetts General Hospital

More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Recht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. Epub 2009 Jul 20.

Responsible Party:	Massachusetts General Hospital ( Alphonse Taghian, MD, PhD )
Study ID Numbers:	03-179
Study First Received:	June 6, 2008
Last Updated:	September 25, 2009
ClinicalTrials.gov Identifier:	NCT00694577 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

non-invasive breast cancer
early invasive breast cancer
radiation
PBI

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 22, 2009