Breast Cancer Clinical Trial

3D-CRT, Proton, or Brachytherapy APBI in Treating Patients With Invasive and Non-invasive Breast Cancer

Summary

This phase II trial studies the side effects of three-dimensional conformal external-beam photon radiotherapy (3D-CRT), proton, or brachytherapy accelerated partial breast irradiation (APBI) in treating patients with breast cancer that has or hasn't spread from where it began in the breast to surrounding normal tissue. Radiation therapy such as photon and proton partial breast external beam radiotherapy, uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in different ways may kill more tumor cells. Brachytherapy, also known as internal radiation therapy, uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether photon or proton partial breast external beam radiotherapy or partial breast brachytherapy works better in treating patients with breast cancer.

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Full Description

PRIMARY OBJECTIVES:

I. To evaluate the rate of adverse cosmesis (defined as fair or poor cosmesis) with accelerated 3 fraction APBI at 3 years, compared to baseline.

SECONDARY OBJECTIVES:

I. To evaluate the acute and late toxicities of accelerated 3 fraction APBI. II. To evaluate local disease control of accelerated 3 fraction APBI. III. To assess the rate of patient reported adverse cosmesis at 2 years, compared to baseline.

IV. To assess quality of life and other patient reported outcomes following accelerated 3 fraction APBI.

V. To compare the local control, acute and late toxicities, cosmesis, quality of life and other patient reported outcomes between the three radiation therapy techniques (3D-CRT, proton, brachytherapy).

VI. To evaluate clinical features, dose-volume parameters, and genetic variants associated with fair and poor cosmetic outcome.

OUTLINE: Patients are assigned to 1 of 3 cohorts.

COHORT I: Patients undergo 3D-CRT APBI for 3-5 days.

COHORT II: Patients undergo proton beam radiation therapy APBI for 3-5 days.

COHORT III: Patients undergo brachytherapy ABPI for 3-5 days.

After completion of study treatment, patients are followed up at 12 weeks, 12 months, and annually for 5 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Grade 1-3 invasive ductal, mammary, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring =< 2.5 cm on final pathology (the tumor should be clinical stage T1N0M0 in patients electing brachytherapy in whom the catheter will be placed intraoperatively)
Estrogen receptor (ER)+ (ER- DCIS meeting other eligibility criteria are eligible)
Unicentric: patients with microscopic multifocality are eligible as long as the total pathologic tumor size is =< 2.5 cm
Surgical treatment of the breast must have been lumpectomy
The final margins of the resected specimen must be histologically free of tumor
Patients with DCIS do not require an axillary staging procedure; for patients with invasive breast cancer (except T1mi), an axillary staging procedure should be performed (either sentinel lymph node biopsy alone or axillary dissection and the axillary node must be pathologically negative) and they should be pathologically node negative; Note: Patients with N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e., if the tumor deposit is 0.2 mm or less as determined by immunohistochemistry or hematoxylin and eosin staining) will also be eligible
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
Ability to complete questionnaire(s) by themselves or with assistance
Ability to elect radiotherapy care in conjunction with their physician
Able and willing to provide written informed consent
Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)
Willing to provide tissue and blood samples for correlative research purposes
Rochester and Arizona patients: Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study and collect involved blood specimen prior to the start of radiation therapy, IRB number 15-000136.

Exclusion Criteria:

Any of the following because this study involves therapy that has known genotoxic, mutagenic and teratogenic effects:

Pregnant women
Nursing women
Women of childbearing potential who are unwilling to employ adequate contraception
Neoadjuvant chemotherapy
Prior history of ipsilateral breast cancer
Prior radiation therapy to the ipsilateral breast or thorax
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Active collagen-vascular disease that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient
Paget?s disease of the breast
Proven multicentric carcinoma (DCIS or invasive) in more than one quadrant or separated by 4 or more centimeters or diffuse (> 1 quadrant) suspicious calcifications
Histologic evidence of angiolymphatic invasion (ALI); Note: Cases termed focally suspicious for ALI but where no definitive ALI is found are eligible
Surgical margins that cannot be microscopically assessed or that are positive
Pathologic tumor > 2.5 cm in size
Metastatic disease
Patients for whom the delivery of APBI is not feasible or any of the dosimetric treatment criteria have not been met
BRCA 1/2 mutation; Note: Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study
Breast implants (patients who have had implants removed are eligible)
Extensive intraductal component
Active connective tissue disease
Reduction mammoplasty if 3DCRT or proton APBI are planned
Last surgery > 10 weeks from enrollment

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT03391388

Recruitment Status:

Active, not recruiting

Sponsor:

Mayo Clinic

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There are 3 Locations for this study

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Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Mayo Clinic
Rochester Minnesota, 55905, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

168

Study ID:

NCT03391388

Recruitment Status:

Active, not recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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