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Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery


Phase 3
18 Years
70 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery


Inclusion Criteria:



1. KPS>=60

2. histology confirmed invasive breast cancer

3. received breast conservative surgery(wide local excision and axilla dissection, or
axillary sentinel node biopsy if sentinel node is negative)

4. surgical margins negative

5. primary tumor ≤5cm in the largest diameter

6. no internal mammary node or supraclavicular node metastases or distant metastasis

7. can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy

8. for patients not need chemotherapy,enrollment date is required no more than 8 weeks
from surgery date

9. for patients with chemotherapy first,enrollment date is required no more than 8 weeks
from the last date of chemotherapy

10. patients signed written inform consent form

Exclusion Criteria:

1. ductal carcinoma in situ

2. prior neoadjuvant chemotherapy

3. prior breast cancer history

4. bilateral breast cancer

5. pregnant or during lactation

6. prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and
cervix carcinoma in situ

7. active collagen vascular disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

in-breast recurrence rate

Outcome Description:

evidence of ipsilateral breast local recurrence confirmed by histology

Outcome Time Frame:

5 year

Safety Issue:

No

Principal Investigator

ye-xiong Li, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Hospital, Chinese Academy of Medical Sciences

Authority:

China: Food and Drug Administration

Study ID:

CH-BC-013

NCT ID:

NCT01413269

Start Date:

June 2010

Completion Date:

June 2019

Related Keywords:

  • Breast Cancer
  • breast cancer patients
  • breast conservation surgery
  • hypofractionated radiotherapy
  • Breast Neoplasms

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