NCT03856372

Brief Summary

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,494

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
30mo left

Started Sep 2018

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

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 Progress76%
Sep 2018Oct 2028

Study Start

First participant enrolled

September 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 27, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2028

Expected
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

5.1 years

First QC Date

February 20, 2019

Last Update Submit

February 25, 2019

Conditions

Breast Cancer

Keywords

Postmastectomy Hypofractionated Adjuvant Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Loco-regional recurrence (LRR)

    Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes). Time to loco-regional recurrence is defined as the interval starting from the date of randomization until the event. LRR will be assessed every 3 months during the first 2 years after the last fraction received, every 6 months during the following 3-5 years and every year thereafter through 10 years

    every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

Secondary Outcomes (14)

  • Distant metastasis free survival (DMFS)

    every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

  • Disease free survival (DFS)

    every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

  • Overall survival (OS)

    every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years

  • CTCAE Toxicity Assessment-Acute toxicity

    before treatment, every week of treatment, the end of treatment, 2 weeks, 3 months after the last fraction received, every year through 10 years

  • CTCAE Toxicity Assessment-Late toxicity

    before treatment, every year after the last fraction received through 10 years

  • +9 more secondary outcomes

Study Arms (2)

Hypofractionated

EXPERIMENTAL

42.5 Gy / 16 fractions, 2.66 Gy per fraction, 5 fractions weekly

Radiation: Hypofractionated

Conventional

ACTIVE COMPARATOR

50 Gy / 25 fractions, 2.00 Gy per fraction, 5 fractions weekly

Radiation: Conventional

Interventions

HypofractionatedRADIATION

daily fractions, five fractions per week.

Also known as: Experimental Arm
Hypofractionated
ConventionalRADIATION

daily fractions, five fractions per week.

Also known as: Standard Arm
Conventional

Eligibility Criteria

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

You may qualify if:

  • Female
  • Age18-75 years
  • Pathologically confirmed invasive breast cancer
  • Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
  • Negative surgical margins
  • Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
  • No distant metastases
  • No supraclavicular or internal mammary nodes metastases
  • ECOG:0-1
  • Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted.
  • No neoadjuvant chemotherapy
  • Fit for postoperative radiotherapy. No contraindications to radiotherapy
  • Signed informed consent

You may not qualify if:

  • Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
  • Previous radiotherapy to the chest wall or regional lymph node areas
  • Patients with severe non-malignant comorbidity in cardiovascular or respiration system
  • Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
  • pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
  • Patients with supraclavicular or internal mammary nodes metastases
  • Known definitive clinical or radiologic evidence of metastatic disease
  • Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
  • Treated with neoadjuvant chemotherapy
  • ECOG: 3-4
  • Pregnant or lactating
  • Conditions indicating that the patient cannot go through the radiation therapy or follow up
  • Unable or unwilling to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Suzhou Municipal hospital

Suzhou, Jiangsu, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Huangpu Branch, Shanghai ninth people's hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose HypofractionationCongresses as Topic

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageRadiotherapyTherapeuticsOrganizationsHealth Care Economics and Organizations

Study Officials

  • Jinli Ma, MD, PhD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinli Ma, MD, PhD

CONTACT

+86-15221033376jinli.ma@aliyun.com

Xingxing Chen, MD, PhD

CONTACT

+86-13585547068xingxing@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of department of radiation oncology

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 27, 2019

Study Start

September 1, 2018

Primary Completion

September 30, 2023

Study Completion (Estimated)

October 30, 2028

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

CN(3)