Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04849871
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Breast Cancer Stage 0 Breast Cancer Stage I Breast Cancer Radiation: External Beam Accelerated Partial Breast Irradiation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Single Fraction Accelerated Partial Breast Irradiation vs. Five Fraction Accelerated Partial Breast Irradiation for Low-risk Stage 0 and I Breast Carcinoma
Actual Study Start Date : August 12, 2021
Estimated Primary Completion Date : June 30, 2029
Estimated Study Completion Date : June 30, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)
-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)
Radiation: External Beam Accelerated Partial Breast Irradiation
APBI simulation must take place no more than 8 weeks from final definitive breast surgery.
Other Name: APBI

Experimental: Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)
-External Beam APBI 30 Gy in 5 fractions over 5 days.
Radiation: External Beam Accelerated Partial Breast Irradiation
APBI simulation must take place no more than 8 weeks from final definitive breast surgery.
Other Name: APBI




Primary Outcome Measures :
  1. Proportion of patients who are free of breast cancer in the treated breast (IBTR) [ Time Frame: At 5 years ]
    -IBTRs will be categorized as local (infield) if they occur within the prescription isodose volume, peripheral if between the prescription isodose volume and a volume 2 cm outside of the prescription isodose volume, and non-contiguous or extrafield if they are beyond the peripheral volume described above.

  2. Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years [ Time Frame: Through enrollment of all participants (estimated to be 3 years) ]

Secondary Outcome Measures :
  1. Proportion of patients who are free of breast cancer in the regional lymph nodes [ Time Frame: At 5 years ]
    -Regional lymph nodes are ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups.

  2. Proportion of patients who are free of distant disease [ Time Frame: At 5 years ]
  3. Proportion of patients who are alive [ Time Frame: At 5 years ]
  4. Change in quality of life as measured by EORTC QLQ-C30 [ Time Frame: Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT ]
    • The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
    • All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  5. Change in quality of life as measured by EORTC QLQ-BR23 [ Time Frame: Baseline, 6 months post-end of radiation therapy (RT), 12 months post-end of RT, 24 months post-end of RT, 36 months post-end of RT, 4 years post-end of RT, and 5 years post-end of RT ]
    • The QLQ-BR23 is a breast-specific module that comprises of 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects, breast symptoms, arm symptoms and upset by hair loss.
    • All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

  6. Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA) [ Time Frame: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years) ]
    -Breast Retraction Assessment (BRA) is an objective evaluation of the amount of cosmetic retraction of the treated breast in comparison to the untreated breast in patients. A clear acrylic sheet supported vertically and marked as a grid at 1 cm intervals is employed to perform the measurements.

  7. Change in cosmesis as measured quantitatively by the Percent Breast Retraction Assessment (pBRA) [ Time Frame: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years ]
    -Breast Retraction Assessment (BRA) is an objective evaluation of the amount of cosmetic retraction of the treated breast in comparison to the untreated breast in patients. A clear acrylic sheet supported vertically and marked as a grid at 1 cm intervals is employed to perform the measurements.

  8. Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded) [ Time Frame: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years ]

    -The following general descriptors will be used:

    • Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
    • Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
    • Fair - there is obvious difference in the size and shape of the treated breast. This change involves ¼ or less of the breast.
    • Poor - marked change in the appearance of the treated breast involving more than ¼ of the breast tissue.

  9. Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (patient graded) [ Time Frame: Before treatment, 4-8 month follow-up, 10-14 month follow-up, 2 years, 3 years, 4 years, and 5 years (estimated to be 5 years ]

    -The following general descriptors will be used:

    • Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance.
    • Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
    • Fair - there is obvious difference in the size and shape of the treated breast. This change involves ¼ or less of the breast.
    • Poor - marked change in the appearance of the treated breast involving more than ¼ of the breast tissue.

  10. Presence of complications [ Time Frame: From start of treatment through 5 years (estimated to be 5 years) ]
  11. Occurrence of mastectomy after completion of initial breast-conserving treatment [ Time Frame: At 5 years ]
  12. Frequency of any CTCAE v5.0 grade 3-4 toxicities [ Time Frame: From start of treatment through 5 years (estimated to be 5 years) ]
  13. Proportion of patients who are free of acute serious treatment related toxicity [ Time Frame: From start of treatment until 6 months post-treatment (estimated to be 6 months) ]
    • Serious treatment related toxicity are those treatment-related grade 3 or higher adverse events as measured by CTCAE v5.0
    • Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis.

  14. Proportion of patients who are free of late serious treatment related toxicity [ Time Frame: From 6 months through 5 years (estimated to be 4.5 years) ]
    • Serious treatment related toxicity are those treatment-related grade 3 or higher adverse events as measured by CTCAE v5.0
    • Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis, and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis, coronary artery disease, and pericarditis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes as assessed by axillary ultrasound, axillary sampling, or axillary sentinel node procedure.
  • Negative histologic margins of partial mastectomy or re-excision specimen. The posterior margin is always considered widely negative if the partial mastectomy extended to the pectoralis fascia and there is no tumor on ink. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.[42]
  • Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive.
  • Neoadjuvant hormone therapy, chemotherapy, or biologic therapy is not allowed prior to APBI, but adjuvant hormone therapy may have been started after surgery. Planned chemotherapy or biologic therapy must not start for at least 4 weeks after the completion of APBI.
  • Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
  • Postmenopausal status.
  • Age ≥ 50 years at diagnosis.
  • Able to understand and willing to sign IRB-approved written informed consent document.
  • All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with the following stipulations: F_APBI may be delivered at any Siteman location. S_APBI treatment must occur at the main Siteman location at BJH and will be delivered on a Viewray Unit, the Varian Edge unit, or the Varian Halcyon unit. Pre and post treatment care is allowed at any Siteman center.

Exclusion Criteria:

  • Presence of distant metastases.
  • Nonepithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
  • Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
  • Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
  • Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
  • Paget's disease of the nipple.
  • Skin involvement, regardless of tumor size.
  • Unsatisfactory breast for APBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with APBI is technically problematic.
  • Partial mastectomy so extensive that the cosmetic result is fair or poor prior to APBI as determined by the treating physician.
  • Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
  • Time between final definitive breast surgical procedures to APBI simulation is greater than 8 weeks.

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): NCT04849871


Contacts
Layout table for location contacts
Contact: Imran Zoberi, M.D. 314-362-8610 izoberi@wustl.edu

Locations
Layout table for location information
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Imran Zoberi, M.D.    314-362-8610    izoberi@wustl.edu   
Principal Investigator: Imran Zoberi, M.D.         
Sub-Investigator: Maria Thomas, M.D., Ph.D.         
Sub-Investigator: Carmen Bergom, M.D., Ph.D.         
Sub-Investigator: Joanna Yang, M.D.         
Sub-Investigator: Laura Ochoa, ANP, Ph.D.         
Sub-Investigator: Alex Price, M.S.         
Sub-Investigator: Yi Huang, M.S.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Layout table for investigator information
Principal Investigator: Imran Zoberi, M.D. Washington University School of Medicine
Additional Information:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04849871    
Other Study ID Numbers: 202104085
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Breast Neoplasms
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Carcinoma in Situ