NCT03829553

Brief Summary

The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
801

participants targeted

Target at P50-P75 for phase_3 breast-cancer

Timeline
19mo left

Started Feb 2019

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Feb 2019Dec 2027

First Submitted

Initial submission to the registry

January 27, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

February 21, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

3.8 years

First QC Date

January 27, 2019

Last Update Submit

May 29, 2022

Conditions

Breast Cancer

Keywords

regional nodal irradiationIMRTHypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Locoregional recurrence (LRR)

    any first recurrence confirmed by histology or cytology in the ipsilateral chest wall or breast or regional nodes areas (including axillary, supraclavicular, infraclavicular lymph nodes or IMN)

    5 years

Secondary Outcomes (7)

  • Distant metastasis free survival (DMFS)

    5 years

  • Invasive recurrence-free survival (IRFS)

    5 year

  • over survival (OS)

    5 years

  • Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/NSABP/RTOG scoring scale

    5 years

  • Number of Participants with ≥Grade1 Acute Radiation-induced Toxicity

    6 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Quality of Life-EORTC QLQ-C30

    1 years

  • Quality of Life-EORTC QLQ-C30

    5 years

  • Quality of Life-EORTC QLQ-BR23

    1 years

  • +1 more other outcomes

Study Arms (2)

Hypofractionated radiotherapy

EXPERIMENTAL

Patients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery

Radiation: Hypofractionated radiotherapy

Conventional radiotherapy

ACTIVE COMPARATOR

Patients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.

Radiation: Conventional radiotherapy

Interventions

Hypofractionated radiotherapyRADIATION

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

Also known as: Experimental Arm
Hypofractionated radiotherapy
Conventional radiotherapyRADIATION

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Also known as: Active Comparator Arm
Conventional radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years old
  • unilateral histologically confirmed invasive breast carcinoma of pT1-3
  • breast conservation surgery or mastectomy
  • Breast reconstruction is allowed
  • histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
  • Life expectancy of \>5 years
  • A minimum negative surgical margin width of \>2mm
  • Karnofsky Performance Status ≥80
  • Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
  • Written informed consent

You may not qualify if:

  • Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
  • Pregnant or lactating
  • Severe non-neoplastic medical comorbidities
  • Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
  • Simultaneous contralateral breast cancer
  • Previous RT to thoracic and/or axillary, cervical region
  • Active collagen vascular disease
  • Evidence of distant metastatic disease and/or T4 disease
  • Notes for exlusion criteria:
  • Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
  • Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (1)

  • Xie J, Xu F, Zhao Y, Cai G, Lin X, Zhu Q, Lin Q, Yao Y, Xu C, Cai R, Wang S, Tang X, Chen C, Zheng S, Chen M, Chen M, Qian X, Shen C, Li J, Xu H, Xu F, Han Y, Li M, Ou D, Shen KW, Qi WX, Cao L, Huang X, Chen J. Hypofractionated versus conventional intensity-modulated radiation irradiation (HARVEST-adjuvant): study protocol for a randomised non-inferior multicentre phase III trial. BMJ Open. 2022 Sep 1;12(9):e062034. doi: 10.1136/bmjopen-2022-062034.

    PMID: 36581983DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeutics

Study Officials

  • Jia-Yi Chen

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Jia-Yi Chen

CONTACT

+86-021-64370045chenjiayi0188@aliyun.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Department of Radiation Oncology

Study Record Dates

First Submitted

January 27, 2019

First Posted

February 4, 2019

Study Start

February 21, 2019

Primary Completion

December 1, 2022

Study Completion (Estimated)

December 1, 2027

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

CN(1)