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Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

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: NCT03411174
Recruitment Status : Unknown
Verified January 2019 by Jinli Ma, Fudan University.
Recruitment status was:  Recruiting
First Posted : January 26, 2018
Last Update Posted : February 4, 2019
Sponsor:
Information provided by (Responsible Party):
Jinli Ma, Fudan University

Study Description
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Brief Summary:
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: hypofractionated partial breast irradiation Not Applicable

Detailed Description:
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients
Study Start Date : April 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

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: HF-PBI
Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.
 Radiation: hypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas


Outcome Measures
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Primary Outcome Measures :
  1. The change of breast cosmetic outcome [ Time Frame: Baseline, and three years after the completion of radiation therapy ]
    The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system


Secondary Outcome Measures :
  1. Acute radiation-induced toxicity assessed by CTCAE v4.0 [ Time Frame: 3weeks, 5weeks,1 and 3 months after treatment beginning ]
    acute toxicity related to skin and lung

  2. Late complications [ Time Frame: 3 years ]
    Complications related to radiation treatment after more than 3 months.

  3. Ipsilateral breast tumor recurrence rate [ Time Frame: 5 years ]
    The pathological confirmed tumor recurrence in the same breast

  4. Local-regional recurrence [ Time Frame: 5 years ]
    Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain.

  5. Disease free survival [ Time Frame: 5 years ]
    The interval from diagnosis to disease recurrence or death or last visit.

  6. Overall survival [ Time Frame: 5 years ]
    The interval from diagnosis to death or last visit


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female
  • Age≥ 50 years
  • Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
  • Negative surgical margins
  • Pathologically confirmed invasive breast cancer
  • A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
  • Tumor bed is labeled with Titanium clips
  • Received adjuvant hormonal treatment
  • No adjuvant chemotherapy
  • ECOG:0-1
  • Written informed consent.

Exclusion Criteria:

  • Age<50 years
  • KPS<70
  • Treated with neoadjuvant chemotherapy
  • Treated or being treated with chemotherapy
  • With severe comorbidity
  • Previous breast cancer or other malignant tumor history
  • Previous radiotherapy for breast or thorax
  • Medical contraindication for radiotherapy
  • Pregnant or nursing
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): NCT03411174


Contacts
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Contact: Jinli Ma, MD,PhD +86 15221033376 jinli.ma@aliyun.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Jinli Ma, MD,PhD    +86 15221033376    jinli.ma@aliyun.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Jinli Ma, MD,PhD Fudan University
More Information
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Responsible Party: Jinli Ma, Associate Professor of department of radiation oncology, Fudan University
ClinicalTrials.gov Identifier: NCT03411174    
Other Study ID Numbers: FDRT-BC003
First Posted: January 26, 2018    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Keywords provided by Jinli Ma, Fudan University:
breast cancer
hypofractionated partial breast irradiation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases