Clinical trial NCT06825975: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancers
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 348
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to explore the efficacy and safety of hyperbaric oxygen therapy in the neoadjuvant treatment of triple-negative and HER2+ breast cancer patients


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

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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

Primary outcomes:
measure: pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients
timeFrame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
Secondary outcomes:
measure: The Miller and payne classification
timeFrame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
measure: RCB 0/1 rate
timeFrame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
measure: RECIST criteria
timeFrame: After completion of the first cycle of neoadjuvant therapy (at about 1 month), After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)
measure: Life quality (EORTC QLQ C-30、EORTC QLQ BR-23 questionnaire)
timeFrame: At the time of patient enrolment, Each cycle of chemotherapy (8cycle, each cycle is 3 weeks) , Day before surgery, 3 months after surgery.
measure: Side effects of hyperbaric oxygen therapy
timeFrame: during the hyperbaric oxygen therapy (up to half a year)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
timeFrame: through study completion ( an average of half a year)
measure: the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy
timeFrame: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
Study officials:
References: