A Phase II Single-Arm Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Triple-Negative and HER2+ Breast Cancer Patients

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Feb 10, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how effective and safe hyperbaric oxygen therapy might be as a treatment before surgery for women with specific types of breast cancer, including triple-negative and HER2-positive breast cancer. Hyperbaric oxygen therapy involves breathing pure oxygen in a pressurized room, which may help improve treatment outcomes. The study is currently not recruiting participants, but it aims to include women aged 18 to 60 who have been diagnosed with certain types of invasive breast cancer that can be treated with neoadjuvant therapy, meaning treatment given before surgery.

To be eligible for the study, participants need to meet several criteria, such as having a confirmed diagnosis of breast cancer, being in good overall health, and not having certain medical conditions that could interfere with the treatment. Women who join the study can expect to receive hyperbaric oxygen therapy along with their regular treatments and will be closely monitored for any effects. It's important for potential participants to understand the requirements and to discuss any questions or concerns with their healthcare provider before considering joining the trial.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Understand the study process, participate in the study voluntarily, and sign the informed consent form.
• • 2. have an initial histopathologically confirmed diagnosis of unilateral primary invasive breast cancer, excluding occult breast cancer, inflammatory breast cancer and eczema-like carcinoma
• • 3. aged ≥ 18 years and ≤ 60 years, female
• • 4. patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (patients with locally advanced breast cancer (AJCC Stage III, except T3N1M0) or operable but not in breast-conserving or axillary-sparing condition (Stage IIA-IIB and T3N1M0), or patients with a certain tumour load of HER2-positive or TNBC with clinical lymph node positivity, or patients with a tumour size of 2cm and above). or tumour size 2cm and above).
• • 5. ECOG performance status 0-1.
• • 6. LVEF ≥ 55%
• • 7. Adequate bone marrow functional reserve: white blood cell count ≥3.0 x 109/L, neutrophil count ≥1.5 x 109/L; platelet count ≥100 x 109/L; haemoglobin ≥90 g/L;
• • 8. AST, ALT ≤ 2.5 times the upper limit of normal value, alkaline phosphatase ≤ 2.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value; serum creatinine ≤ 1.5 times the upper limit of normal value
• • 9. For non-menopausal or non-surgically sterilised female patients: consent to contraception during treatment and for at least 7 months after the last dose of the study treatment
• • -
• Exclusion Criteria:
• • 1. Contraindication to hyperbaric oxygen therapy: untreated pneumothorax. Concurrent use of disulfiram. concomitant administration of anti-tumour drugs such as bleomycin, cisplatin, adriamycin concomitant administration of antineoplastic drugs such as bleomycin, cisplatin, adriamycin. Premature and/or low body mass neonates. Lung disease (severe chronic obstructive pulmonary disease). Diseases of the lungs (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, uncontrolled diarrhoea). controlled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear disease (eustachian tube Dysfunction of the eustachian tube, recurrent episodes of vertigo), ocular disease (retinal detachment).
• • 2. previous hyperbaric oxygen therapy.
• • 3. distant metastases, including lymph node metastases to the contralateral breast and mediastinum.
• • 4. other malignant tumours within the last two years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. Tumour.
• • 5. pregnancy or lactation
• • 6. uncontrolled hypertension, cardiac, hepatic, renal related disease or other medical or psychiatric conditions.
• • 7. major surgical procedure unrelated to breast cancer within 4 weeks prior to randomisation, or the patient has not fully recovered from such procedure; or has not fully recovered from such surgical intervention.
• • 8. serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to Serious or uncontrolled infections that may interfere with study treatment or the evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, and pulmonary infections.
• • 9. recent history of thromboembolism and taking full dose anticoagulant medication.
• • 10. any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study