A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca

NCT02453737 | Completed Phase 2 Results DMC

• 3 other identifiers: 14-002566NCI-2017-02363MC1532
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.

Conditions

Breast Cancer

Keywords

Proton; Brachytherapy; Partial Breast Irradiation; 3D Conformal Photon

Outcome Measures

Primary Outcomes (1)

• Change in the Rate of Adverse Cosmesis (Defined as Fair or Poor Cosmesis) Compared to Baseline Using the Harvard Cosmetic Rating:

  Participants end up being rated as fair or poor cosmesis from baseline. Excellent: treated breast nearly identical to untreated breast Good: treated breast slightly different than untreated (minimal but identifiable effects of the treated breast) Fair: Treated breast clearly different from untreated but not seriously distorted (significant radiation effects readily observable) Poor: Treated breast seriously distorted (severe sequelae of breast tissue secondary to radiation effects)

  Baseline, 3 years

Study Arms (3)

Catheter-based brachytherapy APBI

OTHER

7 Gy x 3 fractions

Radiation: Brachytherapy APBI

3D-CRT APBI

OTHER

7.3 Gy x 3 fractions

Radiation: 3D-CRT (photon) APBI

Proton APBI

OTHER

7.3 Gy x 3 fractions

Radiation: Proton APBI

Interventions

Brachytherapy APBI RADIATION

Catheter-based brachytherapy APBI

3D-CRT (photon) APBI RADIATION

3D-CRT APBI

Proton APBI RADIATION

Proton APBI

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female Age ≥ 50 years at diagnosis
• Grade 1-3 invasive ductal, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring ≤ 2cm (clinical stage T1).
• 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 \<2cm.
• Surgical treatment of the breast must have been lumpectomy.
• The final margins of the resected specimen must be histologically free of tumor.
• Pathologically node negative Note: For patients with T1a, T1b, T1c 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). Patients with N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e., if the tumor deposit is 0.2mm or less as determined by immunohistochemistry or hematoxylin and eosin staining) will also be eligible.
• 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
• Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136

You may not qualify if:

• 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 angiolympatic 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 \>2cm in size
• Metastatic disease

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy, Conformal; Photons

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Elementary Particles; Physical Phenomena; Light; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Optical Phenomena; Radiation; Radiation, Nonionizing

Results Point of Contact

• Title: Dr. Robert W. Mutter
• Organization: Mayo Clinic

Mutter.Robert@mayo.edu

507-284-3191

Study Officials

• Robert Mutter, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: May 25, 2015
• Study Start: June 16, 2015
• Primary Completion: October 3, 2020
• Study Completion: September 21, 2022
• Last Updated: September 19, 2024
• Results First Posted: August 1, 2023

Record last verified: 2024-04

Locations

US (3)