Breast cancer with lung metastasis
Conditions
Interventions
Hyperbaric oxygen-combined treatment group:hyperbaric oxygen therapy
Sponsors
Jinan Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed breast cancer with evidence of lung metastasis (confirmed by imaging such as chest CT, PET-CT); 2. At least one measurable lung metastatic lesion according to RECIST version 1.1 (>=10 mm on spiral CT or MRI, and the lesion has not received prior radiotherapy); 3. Prior systemic therapy for breast cancer (e.g., chemotherapy, targeted therapy, endocrine therapy, etc.) with documented progression of lung metastases after prior treatment; 4. Essential normal functions of major organs: Routine blood tests: HB >= 90 g/L (no blood transfusion within 14 days); ANC >= 1.5 × 10?/L; PLT >= 75 × 10?/L. Biochemical tests: TBIL 50 mL/min (calculated using the Cockcroft-Gault formula). Electrocardiogram (ECG): No severe arrhythmias, myocardial ischemia, or other significant abnormalities. 5. Patients must not have received radiotherapy or undergone surgery (with the exception of minor outpatient surgeries such as vascular access device placement) within 3 weeks before study initiation, and must have recovered from any acute toxicity related to previous therapies (excluding hair loss); 6. ECOG performance status = 3 months; 7. Female subjects of childbearing potential must agree to use a medically approved contraceptive method during the study treatment period and for at least 3 months after the last use of the intervention; 8. Willing to participate voluntarily in this study, sign informed consent form, have good compliance, and cooperate with follow-up; 9. Female patients aged >= 18 years and <= 75 years old.
Exclusion criteria
Exclusion criteria: 1. Presence of uncontrolled cardiac diseases, including congestive heart failure, myocardial infarction within the past 6 months, unstable angina, severe ventricular arrhythmias, etc; 2. Presence of severe pulmonary diseases, such as active pulmonary tuberculosis, pulmonary bullae, uncontrolled pneumothorax, or recent pulmonary embolism; 3. Persistent adverse reactions of Grade >= 2 (per CTCAE criteria) resulting from prior treatment, with the exception of alopecia; 4. Presence of third-space fluid accumulation that cannot be controlled by drainage (e.g., massive pleural effusion, ascites); 5. Active phase of known HBV or HCV infection (HBV DNA >= 500 IU/mL or HCV RNA positive) with abnormal liver function; 6. Clear contraindications to hyperbaric oxygen therapy, such as history of epilepsy, claustrophobia with inability to tolerate the hyperbaric chamber environment, severe uncontrolled sinusitis or otitis media, etc; 7. Pregnant or breastfeeding women; 8. Allergic constitution, or known allergy to any components of the conventional study treatment regimen.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events;Progression-Free Survival;Disease Control Rate (DCR);CTC Number and Viability; | — |
Countries
China
Contacts
Public ContactZhang Nan
Jinan Central Hospital
Outcome results
None listed