NCT05692661

Brief Summary

Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant. Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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 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
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2.8 years

First QC Date

January 11, 2023

Last Update Submit

January 11, 2023

Conditions

Triple Negative Breast CancerHER2-positive Breast Cancer

Keywords

Breast CancerHER2 PositiveTriple NegativeProton and Carbon IonDose Escalation

Outcome Measures

Primary Outcomes (1)

  • Acute toxicity

    Treatment related acute toxicity assessed by CTCAE v4.03

    3 months after the completion of CIRT

Secondary Outcomes (3)

  • Local regional recurrence

    within 5 years after radiotherapy.

  • Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale

    within 5 years after radiotherapy.

  • Cosmetic outcome as measured by BCCT.core software

    within 5 years after radiotherapy.

Study Arms (1)

proton plus carbon ion radiotherapy

EXPERIMENTAL

CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.

Radiation: proton plus carbon ion radiotherapy

Interventions

proton plus carbon ion radiotherapyRADIATION

CTV1: whole breast, 40.05Gy(RBE) in 15 fractions with proton ion therapy; CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels \[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \].

proton plus carbon ion radiotherapy

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry \[IHC\] 3+ and or fluorescence in situ hybridization \[FISH\] amplified; Triple Negative: estrogen receptor \[ER\] and progesterone receptor \[PR\] \< 1%, HER2 negative \[IHC 1+ or 2+ FISH non-amplified\])
  • Age ≥ 18 years and ≤ 80 years.
  • The primary tumor must be excised via breast conserving surgery.
  • Stage p T1-2 N0 M0
  • ECOG performance status ≤2.

You may not qualify if:

  • Invasive breast cancer not confirmed by pathology.
  • Distant metastasis
  • Prior thoracic radiation.
  • Pregnancy or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Proton and Heavy Ion center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast NeoplasmsBreast Neoplasms

Interventions

ProtonsHeavy Ion Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical PhenomenaRadiotherapyTherapeutics

Study Design

Study Type
interventional
Phase
phase 1
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

October 10, 2025

Study Completion

January 10, 2026

Last Updated

January 20, 2023

Record last verified: 2023-01

Locations

CN(1)