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Proton Accelerated Partial Breast Irradiation (APBI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940248
Recruitment Status : Withdrawn (Due to insurance non-payment, no subjects were enrolled.)
First Posted : May 7, 2019
Last Update Posted : October 6, 2021
Sponsor:
Information provided by (Responsible Party):
Teresa Meier, University of Cincinnati

Study Description
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Brief Summary:

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.


Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Proton Accelerated Partial Breast Irradiation Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : July 8, 2021
Actual Study Completion Date : July 8, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Early Stage Breast Cancer
Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.
 Radiation: Proton Accelerated Partial Breast Irradiation
38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions


Outcome Measures
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Primary Outcome Measures :
  1. Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]

  2. Cosmetic outcome (change in appearance as compared to untreated breast) [ Time Frame: Through Study Completion, an average of 2 years ]
    Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]


Secondary Outcome Measures :
  1. Rates of acute (within 3 months of treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. Rates of late (> 3 months after treatment) toxicity [ Time Frame: Through Study Completion, an average of 2 years ]
    Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease. [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy

  4. Rate of regional recurrence [ Time Frame: Through Study Completion, an average of 2 years ]
    Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  • Patients must be ≥ 50 years old.
  • Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
  • Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
  • Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
  • On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.
  • Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
  • Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
  • The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
  • Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
  • Proton APBI should start within 12 weeks from the time of surgery.

Exclusion Criteria:

  • Male
  • Patients < 50 years of age.
  • Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
  • If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
  • Patients with persistently positive margins despite attempted re-excision.
  • Proven multicentric disease or extensive LVSI.
  • Clear delineation of the extent of the target partial mastectomy cavity is not possible.
  • Patients who have undergone oncoplastic reconstruction.
  • Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
  • Any patients who require adjuvant chemotherapy following lumpectomy.
  • Patients whose primary tumor is ER negative.
  • Patients with high grade ductal carcinoma in situ.
  • Patients with known BRCA1 or BRCA2 mutation.
  • Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
  • Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
  • Pregnancy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940248


Locations
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United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
More Information
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Additional Information:

Publications:
Howlader N, N.A., Krapcho M, Miller D, Bishop K, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). . SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. . 2017; Available from: https://seer.cancer.gov/csr/1975_2014/
Byun, D.J., et al., Omission of Adjuvant Radiation Therapy Following Breast Conservation Surgery for Ductal Carcinoma In Situ: Analysis of the National Cancer Data Base. International Journal of Radiation Oncology • Biology • Physics. 96(2): p. E38.
Julian, T.B., et al., Early Toxicity Results with 3-D Conformal External Beam Therapy (CEBT) from the NSABP B-39/RTOG 0413 Accelerated Partial Breast Irradiation (APBI) Trial. International Journal of Radiation Oncology • Biology • Physics. 81(2): p. S7.

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Responsible Party: Teresa Meier, Associate Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT03940248    
Other Study ID Numbers: 2019-0088
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: October 6, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teresa Meier, University of Cincinnati:
Proton Therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases