Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progressio… (NCT07514728) | Clinical Trial Compass
By InvitationNot Applicable
Concept-verification Clinical Trial on the Inhibition of Breast Cancer Lung Metastasis Progression by Hyperbaric Oxygen
China10 participantsStarted 2025-11-24
Plain-language summary
This is a proof-of-concept clinical trial focused on exploring whether hyperbaric oxygen therapy (HBOT) can inhibit the progression of lung metastasis in breast cancer patients. Patients enrolled in this arm will receive standard breast cancer treatment combined with HBOT.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Aged 18-75 years, female;
✓. Histologically confirmed invasive breast cancer with lung metastasis (diagnosed via contrast-enhanced chest CT, PET-CT, or MRI);
✓. Disease progression after at least 1 line of systemic therapy containing chemotherapy for recurrent/metastatic disease (per RECIST 1.1 criteria);
✓. At least one measurable lung metastatic lesion (≥10 mm on spiral CT/MRI, not previously treated with radiotherapy) per RECIST 1.1;
✓. Adequate organ function (e.g., hemoglobin ≥90 g/L, alanine transaminase/aspartate transaminase ≤3× upper limit of normal \[ULN\], serum creatinine ≤1× ULN, no severe arrhythmia or myocardial ischemia on ECG);
✓. ECOG performance status ≤2 and life expectancy ≥3 months;
✓. Use of medically approved contraception (for women of childbearing potential) during treatment and for at least 3 months after the last treatment;
✓. Voluntary participation, signed informed consent, and willingness to comply with treatment and follow-up.
Exclusion criteria
✕. Received radiotherapy (excluding palliative radiotherapy) within 3 weeks prior to treatment; received major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment;
✕. Persistent grade ≥2 adverse events from prior treatments (e.g., chemotherapy, surgery) (except alopecia or conditions the investigator deems should not result in exclusion);
What they're measuring
1
Objective Response Rate
Timeframe: From the time of registration to 6 weeks after the end of treatment (that is, at 8 weeks)
✕. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina pectoris, myocardial infarction within the past 6 months, or ventricular arrhythmias;
✕. Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods;
✕. Active HBV or HCV infection (HBV DNA ≥500 IU/ml or positive HCV RNA) with abnormal liver function;
✕. Currently pregnant or breastfeeding;
✕. Allergic diathesis, or known history of allergy to components of the conventional treatment medications in this study, or to HBOT-related equipment/gas components (e.g., pure oxygen);
✕. Presence of contraindications to HBOT, such as untreated pneumothorax, pulmonary bullae, severe emphysema, history of epilepsy (with seizures within the past 2 years), or acute exacerbation of severe sinusitis/otitis media.