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

Primary Purpose

Triple Negative Breast Cancer, HER2-positive Breast Cancer

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

proton plus carbon ion radiotherapy

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Breast Cancer, HER2 Positive, Triple Negative, Proton and Carbon Ion, Dose Escalation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Shanghai Proton and Heavy Ion centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

proton plus carbon ion radiotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

Acute toxicity

Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

Local regional recurrence

The Ipsilateral breast and regional lymph nodes recurrence

Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale

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

Cosmetic outcome as measured by BCCT.core software

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.

Full Information

NCT ID

NCT05692661

First Posted

January 11, 2023

Last Updated

January 11, 2023

Sponsor

Shanghai Proton and Heavy Ion Center

1. Study Identification

Unique Protocol Identification Number

NCT05692661

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 10, 2023 (Anticipated)

Primary Completion Date

October 10, 2025 (Anticipated)

Study Completion Date

January 10, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Proton and Heavy Ion Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer, HER2-positive Breast Cancer

Keywords

Breast Cancer, HER2 Positive, Triple Negative, Proton and Carbon Ion, Dose Escalation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

proton plus carbon ion radiotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

proton plus carbon ion radiotherapy

Intervention Description

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 ].

Primary Outcome Measure Information:

Title

Acute toxicity

Description

Treatment related acute toxicity assessed by CTCAE v4.03

Time Frame

3 months after the completion of CIRT

Secondary Outcome Measure Information:

Title

Local regional recurrence

Description

The Ipsilateral breast and regional lymph nodes recurrence

Time Frame

within 5 years after radiotherapy.

Title

Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale

Description

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

Time Frame

within 5 years after radiotherapy.

Title

Cosmetic outcome as measured by BCCT.core software

Description

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.

Time Frame

within 5 years after radiotherapy.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Shanghai Proton and Heavy Ion center

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ping Li

Phone

+86 021-38296666

ping.li@sphic.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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