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

Официальное название

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

Обзор

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

Вмешательства

• Устройство 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).

Первичные конечные точки

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

Вторичные конечные точки (7)

• pCR rate after hyperbaric oxygen combined with neoadjuvant therapy in breast cancer patients [Срок оценки: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]
• The Miller and payne classification [Срок оценки: After completion of standard cycle of neoadjuvant therapy (through study completion, an average of half a year)]
• RECIST criteria [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: during the hyperbaric oxygen therapy (up to half a year)]
• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [Срок оценки: through study completion ( an average of half a year)]
• the Tumor immune microenvironment of the Hyperbaric Oxygen Therapy and neoadjuvant therapy [Срок оценки: the time when the patient enrollment, at the end of the first cycle of neoadjuvant therapy (at about the first month) , surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT06825949 · KY2024-1084-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗