A Clinical Study to Explore the Efficacy and Safety of Hyperbaric Oxygen in the Neoadjuvant Treatment of Hormone Receptor Positive 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 Hormone Receptor Positive Breast Cancer Patients

Overview

The goal of this study is to explore the efficacy and safety of hyperbaric oxygen in the neoadjuvant treatment of hormone receptor positive breast cancer patients

Interventions

• Device Hyperbaric oxygen treatment
  Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, with a minimum of 5 hyperbaric oxygen treatments per chemotherapy cycle, one per day for 60-90 minutes, for a total of 30-40 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA).

Primary outcome measures

• RCB 0/1 rate [Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]

Secondary outcome measures (7)

• pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients [Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]
• The Miller and payne classification [Time frame: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]
• RECIST criteria [Time frame: After completion of the first cycle of adjuvant therapy, After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]
• Life quality (EORTC QLQ C-30、EORTC QLQ BR-23 questionnaire) [Time frame: At the time of patient enrolment, Each cycle of chemotherapy (8 cycle, each cycle is 3 weeks) , Day before surgery, 3 months after surgery]
• Side effects of hyperbaric oxygen therapy [Time frame: during the hyperbaric oxygen therapy (up to half a year)]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Time frame: through study completion ( an average of half a year)]
• the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy [Time frame: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery]

Eligibility criteria

Inclusion criteria

• understood the study process, volunteered to participate in this study and signed an informed consent form
• Patients with histopathologically confirmed diagnosis of initial unilateral primary invasive breast cancer, occult breast cancer, Inflammatory breast cancer and eczema-like carcinoma are excluded.
• Female, aged ≥ 18 years and ≤ 60 years.
• Patients who meet the inclusion criteria of neoadjuvant therapy to receive neoadjuvant therapy for breast cancer (locally advanced breast cancer (AJCC Stage III, except T3N1M0), or operable, but do not meet the conditions of breast conservation or axillary preservation (Stage IIA-IIB and T3N1M0).
• Hormone receptor-positive breast cancer (Luminal/HER2-low (IHC 2+/FISH-negative)).
• ECOG performance status 0-1.
• LVEF ≥ 55 per cent
• 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 ≥ 90g/L;
• 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
• 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 study treatment

Exclusion criteria

• have contraindications to hyperbaric oxygen therapy: lung disease (severe chronic obstructive airway disease, herpetic lung disease, acute or chronic lung infections, uncontrolled asthma, untreated pneumothorax), previous history of middle ear surgery, middle ear disease (eustachian tube dysfunction\\recurrent vertigo), eye disease (retinal detachment).
• Previous hyperbaric oxygen therapy.
• Distant metastases, including lymph node metastases in the contralateral breast and mediastinum.
• Malignancy other than radically treated basal or squamous cell carcinoma of the skin or CIS of the uterine cervix within the last two years.
• Pregnancy or lactation.
• Uncontrolled hypertension, cardiac, hepatic, renal related diseases or other medical or psychiatric disorders.
• Major surgical procedures unrelated to breast cancer within 4 weeks prior to randomisation, or patients who have not fully recovered from such surgical procedures.
• Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, pulmonary infection, or other infections.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Guangdong Provincial People's Hospital — Guangzhou

Identifiers

NCT: NCT06825949 · KY2024-1084-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗