Breast Cancer Clinical Trial

Hypofractionated Partial Breast Irradiation in Treating Patients With Early Stage Breast Cancer

Summary

This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

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Full Description

PRIMARY OBJECTIVE:

I. The risk of grade 2 or higher toxicity occurring during radiation and through the 6 month post-radiation follow up visit in patients treated with Optimizing Preventative Adjuvant Linac-based Radiation (OPAL) regimen.

SECONDARY OBJECTIVES:

I. To measure patient-reported cosmetic outcome, functional status, and breast pain with the OPAL regimen at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen.

II. To measure physician-reported and photographically-assessed cosmetic outcome at 6 months, one year, two years, three years, four years, and five years after completing the OPAL regimen and to compare this to the best performing arm of 2010-0559.

III. To determine the 5-year risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal breast carcinoma in situ (DCIS) and early invasive breast cancer.

IV. To determine the 5-year risk of any recurrence of breast cancer, disease-free survival, and overall survival.

V. To determine maximal late (within 5 years) toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 scale.

VI. To establish the feasibility of conducting multi-center radiation therapy trials within the MD Anderson Network.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo hypofractionated partial breast irradiation daily for 10 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.

ARM II: Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.

After completion of study treatment, patients are followed up at 6 months, and at 1.5, 3.5, and 5.5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis of pathologically-confirmed invasive breast cancer or ductal carcinoma in situ
Pathologic T stage of Tis, T1, or T2 with total size of tumor =< 3 cm (this size criteria applies to both pure DCIS and invasive tumors)
For patients with invasive breast cancer, pathologic N stage of N0, N0 (i-), or N0 (i+); pathologic staging of the axilla is not required for patients with pure DCIS
Treatment with breast conserving surgery
Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
Final surgical margins negative defined as no tumor on ink; lobular carcinoma in situ involving the final surgical margin will be disregarded
For invasive cancers, the tumor must be estrogen receptor positive (defined as 10% or greater expression of estrogen receptor)
If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed at least one month prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of cytotoxic chemotherapy
Final criteria for eligibility established after simulation: The tumor bed can be readily visualized on simulation computed tomography (CT) and is localized to one quadrant or region of the breast that is amenable to partial breast irradiation

Exclusion Criteria:

Tumor invasion of the skin including dermis, chest wall, or pectoralis musculature
Any evidence of nodal positivity beyond pathologic stage of pN0(i+)
Systemic chemotherapy prior to final breast conserving surgery
Patient is pregnant or nursing
History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
History of prior invasive or in situ cancer in either breast
Current diagnosis of bilateral breast cancer
History of lupus or scleroderma

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

778

Study ID:

NCT03077841

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There are 15 Locations for this study

See Locations Near You

Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States More Info
Cynthia S. Anderson
Contact
[email protected]
Cynthia S. Anderson
Principal Investigator
Piedmont Hospital
Atlanta Georgia, 30309, United States More Info
Adam W. Nowlan
Contact
[email protected]
Adam W. Nowlan
Principal Investigator
Community Cancer Center East
Indianapolis Indiana, 46219, United States More Info
Benjamin D. Smith
Contact
713-563-2380
Daniel W. Weed
Principal Investigator
Covenant Medical Center Harrison
Saginaw Michigan, 48602, United States More Info
James Fugazzi
Contact
[email protected]
James Fugazzi
Principal Investigator
Summit Medical Group
Berkeley Heights New Jersey, 07922, United States More Info
Benjamin D. Smith
Contact
713-563-2380
Molly Gabel
Principal Investigator
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States More Info
Ashish B. Patel
Contact
[email protected]
Ashish B. Patel
Principal Investigator
MD Anderson Cancer Center at Cooper-Voorhees
Voorhees New Jersey, 08043, United States More Info
Stuti Ahlawat
Contact
[email protected]
Stuti Ahlawat
Principal Investigator
Presbyterian Hospital
Albuquerque New Mexico, 87106, United States
OhioHealth Mansfield Hospital
Mansfield Ohio, 44903, United States More Info
Praveen Dubey
Contact
614-566-1250
Praveen Dubey
Principal Investigator
MD Anderson in The Woodlands
Conroe Texas, 77384, United States More Info
Elizabeth S. Bloom
Contact
713-563-9600
Elizabeth S. Bloom
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Benjamin D. Smith
Contact
713-563-2380
Benjamin D. Smith
Principal Investigator
MD Anderson West Houston
Houston Texas, 77079, United States More Info
Elizabeth S. Bloom
Contact
713-563-9600
Elizabeth S. Bloom
Principal Investigator
MD Anderson League City
League City Texas, 77573, United States More Info
Elizabeth S. Bloom
Contact
713-563-9600
Elizabeth S. Bloom
Principal Investigator
Saint Luke's Baptist Health System
San Antonio Texas, 78229, United States More Info
Cynthia S. Anderson
Contact
[email protected]
Cynthia S. Anderson
Principal Investigator
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
MD Anderson in Sugar Land
Sugar Land Texas, 77478, United States More Info
Elizabeth S. Bloom
Contact
713-563-9600
Elizabeth S. Bloom
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

778

Study ID:

NCT03077841

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

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