Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
NCT ID: NCT00694577
Last Updated: 2022-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
324 participants
INTERVENTIONAL
2003-09-30
2021-06-30
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Irradiation using 32 Gy / 8 fractions
Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions
32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions
40 Gy-10 Treatments, 5 Treatment days
Irradiation using 36 Gy / 9 fractions
Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions
32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions
40 Gy-10 Treatments, 5 Treatment days
Irradiation using 40 Gy / 10 fractions
Study Participants 201-330 Partial Breast Irradiation using 40 Gy / 10 fractions BID in one week
Partial Breast Irradiation using 32 Gy / 8 fractions
32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions
40 Gy-10 Treatments, 5 Treatment days
Interventions
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Partial Breast Irradiation using 32 Gy / 8 fractions
32 Gy-8 Treatments, 4 Treatment Days
Partial Breast Irradiation using 36 Gy / 9 fractions
36 Gy- 9 Treatments, 4 1/2 Treatment Days
Partial Breast Irradiation using 40 Gy /10 fractions
40 Gy-10 Treatments, 5 Treatment days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Boston Medical Center
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Alphonse Taghian, MD, PhD
Professor of Radiation Oncology, Harvard Medical School
Principal Investigators
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Alphonse Taghian, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Pashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30.
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. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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03-179
Identifier Type: -
Identifier Source: org_study_id
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