NCT05692674

Brief Summary

The incidence of breast reconstruction failure after conventional photon radiotherapy for breast cancer is about 18.7%. At present, there is limited data on proton radiotherapy for post operative breast cancer with implantation reconstruction. Proton radiotherapy for breast cancer can significantly reduce the radiation dose of the ipsilateral heart and lung, thereby reducing the incidence of cardiac events and radiation pneumonia. This study is aimed at the study of adjuvant hypofractionated intensity-modulated proton radiotherapy for post operative breast cancer with implantation reconstruction. It can provide an ideal treatment option for such patients to effectively protect the heart and lungs without increasing the failure rate of breast reconstruction after adjuvant radiotherapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
28mo left

Started Jan 2023

Typical duration for phase_2 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 Progress60%
Jan 2023Sep 2028

Study Start

First participant enrolled

January 10, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

5.6 years

First QC Date

January 11, 2023

Last Update Submit

January 11, 2023

Conditions

Breast Cancer

Keywords

breast cancerhypofractionatedproton radiotherapyimplantation reconstructionpostoperative adjuvant radiotherapy

Outcome Measures

Primary Outcomes (1)

  • the failure rate of breast reconstruction after hypofractionated proton radiotherapy

    Reoperation

    within 2 years after hypofractionated proton radiotherapy

Secondary Outcomes (2)

  • Acute and late toxicities

    within 5 years after radiotherapy

  • Tumor local control rate, overall survival rate and progression free survival rate

    within 5 years after radiotherapy

Study Arms (1)

adjuvant hypofractionated intensity-modulated proton radiotherapy

EXPERIMENTAL

CTV1: chest wall ± regional lymph drainage area, proton therapy.

Radiation: adjuvant hypofractionated intensity-modulated proton radiotherapy

Interventions

adjuvant hypofractionated intensity-modulated proton radiotherapyRADIATION

CTV1: chest wall ± regional lymph drainage area, 40.05Gy (RBE) in 15 fractions with proton radiotherapy;

adjuvant hypofractionated intensity-modulated proton radiotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • : Patients with pathologically confirmed breast cancer
  • : Indications: patients who need adjuvant radiotherapy after mastectomy and implant reconstruction
  • : No distant metastasis
  • : Had no chest and breast radiotherapy history
  • : Between the ages of 18 and 80
  • : ECOG general status score is 0-2,There are no serious pulmonary hypertension, cardiovascular disease, peripheral vascular disease, serious chronic heart disease and other complications that may affect the radiotherapy
  • : Non pregnancy (confirmed by serum or urine β- HCG test) or lactating women
  • : The patient must sign the informed consent form for receiving radiotherapy.

You may not qualify if:

  • : No pathological confirmation；
  • : Distant metastasis；
  • : Had chest and breast radiotherapy history
  • : Organs at risk could not achieve safe dose
  • : Pregnancy (confirmed by serum or urine β- HCG test) or lactating women
  • : Poor general health status, i.e. KPS\<70, or ECOG\>2
  • : There are serious complications that may affect the radiotherapy, including: a) unstable angina, congestive heart failure and myocardial infarction requiring hospitalization in the past 6 months； b) Acute bacterial or systemic fungal infection；c) Chronic obstructive pulmonary disease exacerbation or other respiratory diseases need hospitalization； d) Patients with immunosuppression；e) With connective tissue disease, such as active scleroderma or lupus and other contraindications to radiotherapy；
  • : Unable to understand the purpose of treatment or unwilling/unable to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Proton and Heavy Ion center

Shanghai, Shanghai Municipality, 201321, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

January 10, 2023

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

CN(1)