A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer

Sponsor
Shanghai Proton and Heavy Ion Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05692661
Collaborator
(none)
24
1
1
36
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: proton plus carbon ion radiotherapy
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
Anticipated Study Start Date :
Jan 10, 2023
Anticipated Primary Completion Date :
Oct 10, 2025
Anticipated Study Completion Date :
Jan 10, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: proton plus carbon ion radiotherapy

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

Radiation: proton plus carbon ion radiotherapy
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 ].

Outcome Measures

Primary Outcome Measures

  1. Acute toxicity [3 months after the completion of CIRT]

    Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

  1. Local regional recurrence [within 5 years after radiotherapy.]

    The Ipsilateral breast and regional lymph nodes recurrence

  2. Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale [within 5 years after radiotherapy.]

    Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.

  3. Cosmetic outcome as measured by BCCT.core software [within 5 years after radiotherapy.]

    Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC) cosmetic outcome will be assessed.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • Invasive breast cancer not confirmed by pathology.

  • Distant metastasis

  • Prior thoracic radiation.

  • Pregnancy or lactating.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Proton and Heavy Ion center Shanghai China

Sponsors and Collaborators

  • Shanghai Proton and Heavy Ion Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qing Zhang,MD, Professor, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT05692661
Other Study ID Numbers:
  • SPHIC-TR-BCa2022-01
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Qing Zhang,MD, Professor, Shanghai Proton and Heavy Ion Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023