Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer

Phase I/II clinical trial of radical radiotherapy using carbon-ion beams for early breast cancer - Breast I (Protocol 1301)

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010848

Enrollment

Registered

2013-05-31

Start date

2013-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Carbon ion radiotherapy 48 to 60GyE/4fr/4days

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Pathologically proven invasive ductal carcinoma. 2.Tumor 2 cm or less on MRI. UICC clinical stage I. 3.Estrogen receptor positive, HER2 negative, No Lymphovascular space invasion, No extensive intraductal component 4.Performance status 0 to 2 5.Age 60 years old and over. 6.No other life-threatening illness 7.Written informed consent

Exclusion criteria

Exclusion criteria: 1.Severe complication 2.Previous treatment 3.Active double primary 4.Tumor invasion to skin or chest wall 5.Distance between tumor border to skin less than 5mm. 6.Previous irradiation at tumor site 7. Non invasive ductal carcinoma 8. Medically, psychologically or other reason who are not suitable for candidate

Design outcomes

Primary

Measure	Time frame
1.Acute toxicities of normal tissue 2.Local control	—

Countries

Japan

Contacts

Public ContactKumiko Karasawa

National Institute of Radiological Sciences Research Center Hospital for Charged Particle Therapy National Institute of Radiological Sciences

kkarasaw@nirs.go.jp043-206-3306

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026