A multicenter, single-arm, phase II clinical trial of SBRT in the treatment of postoperative breast cancer with pulmonary oligometastasis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300068914

Enrollment

Unknown

Registered

2023-03-01

Start date

2023-03-01

Completion date

Unknown

Last updated

2023-05-22

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

Conditions

Breast cancer

Interventions

Group of breast cancer:SBRT

Eligibility

Sex/Gender

Female

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Histopathologically confirmed postoperative breast cancer patients with pulmonary oligometastasis, which was defined as a maximum of 5 metastases in bilateral lung lobes; 2. Lung metastases improved or stabilized after standard systemic treatment; After drug withdrawal or maintenance treatment for 2 months, the lesions in the lung were well controlled; 3. Maximum diameter of lung metastasis =6 months; 7. Adequate blood function: absolute neutrophil count (ANC) >=1.5x10^9/L and platelet count >=80x10^9/L and hemoglobin >=8g/dL; 8. Adequate liver function: total bilirubin =50mL/min; 10. Electrocardiogram is basically normal; 11. Women with an intact uterus must have had a negative pregnancy test result within 28 days of enrollment in the study (unless they have had amenorrhea for 24 months); 12. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Lactating patients, or female patients who are fertile but have not taken contraceptive measures; 2. There is a severe acute infection that has not been controlled; Or have suppurative and chronic infection, the wound prolonged does not heal; 3. Patients with pre-existing severe heart disease, including congestive heart failure, uncontrolled high-risk arrhythmias, unstable angina, myocardial infarction, severe valvular heart disease, and refractory hypertension; 4. Patients with bleeding tendency; 5. Patients with mental disorders; 6. Patients with drug and chronic alcohol abuse that affect the evaluation of test results; 7. Other conditions in which the investigator thinks the patient should not participate in the study; 8. Patients with recurrence of the primary breast lesion.

Design outcomes

Primary

Measure	Time frame
objective response rate;	—

Secondary

Measure	Time frame
progression-free survival;safety assessment;	—

Countries

China

Contacts

Public ContactPeng Peijian

The Fifth Affiliated Hospital of Sun Yat-Sen University

pengpj@163.com+86 13926925425

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026