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Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT03583580
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Shu lian Wang, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Neoplasm Recurrence, Local Radiation: Accelerated Partial Breast Irradiation Not Applicable

Detailed Description:
This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 537 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Accelerated Partial Breast Irradiation
Accelerated partial breast irradiation (APBI) to the region of tumour bed
 Radiation: Accelerated Partial Breast Irradiation
Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)


Outcome Measures
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Primary Outcome Measures :
  1. locoregional control rate [ Time Frame: 5 years ]
    ipsilateral breast and axilla nodal relapse rate


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
    any death

  2. disease-free survival [ Time Frame: 5 years ]
    any recurrence or death

  3. distant-metastasis survival [ Time Frame: 5 years ]
    distant metastasis


Other Outcome Measures:
  1. acute and late adverse events assessed by CTCAE v4.0 [ Time Frame: 5 years ]
    acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result

  2. quality of life measured with BR-23 questionnaire [ Time Frame: 2 years ]
    BR-23 questionnaire

  3. the incidence of second malignancy [ Time Frame: 5 year ]
    pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Life Expectation: > 5 years
  • Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
  • Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
  • Unifocal tumour (confirmed by diagnostic MRI)
  • No lymphovascular invasion
  • ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
  • Negative radial resection margins of >= 2 mm
  • Surgical clips placed in the tumor bed
  • Written informed consent.

Exclusion Criteria:

  • Stage Ⅱ-Ⅲ
  • Multifocal tumors
  • Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive lobular carcinoma
  • Paget's disease of the nipple
  • Underwent oncoplastic surgery of ipsilateral breast
  • Underwent neoadjuvant chemotherapy or hormonal therapy
  • Previous or simultaneous contralateral breast cancer
  • Undergone ipsilateral chest wall radiotherapy
  • Active collagen vascular disease.
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): NCT03583580


Contacts
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Contact: Guangyi Sun, M.D. 08618811100731 sunliving@yahoo.com
Contact: Shulian Wang, M.D. 8610-87788803 wangsl@cicams.ac.cn

Locations
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China, Beijing
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Shu-lian Wang, M.D.         
Principal Investigator: Shulian Wang, M.D.         
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Shulian Wang, M.D. National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences
More Information
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Responsible Party: Shu lian Wang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT03583580    
Other Study ID Numbers: NCC201804006
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
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 Shu lian Wang, Chinese Academy of Medical Sciences:
Breast conserving surgery
Accelerate partial breast irradiation
intensity-modulated radiation therapy
phase II
Additional relevant MeSH terms:
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Neoplasms
Breast Neoplasms
Neoplasm Recurrence, Local
Recurrence
Disease Attributes
 Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes