Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis

Официальное название

A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis

Обзор

A Randomized, Open Label, Phase III Trial to Evaluate Radical Local Treatment versus Palliative Treatment for Breast Cancer Patients with Primary Ipsilateral Humerus or Sternum Oligometastasis

Подробное описание

This is a prospective, randomized, and multicenter study to compare the radical local treatment versus palliative treatment for breast cancer patients with primary ipsilateral humerus or sternum oligometastasis.

183 subjects will be randomized divided into two groups (experimental group and control group) at a ratio of 2 to 1.

Control group: Palliative treatment. No radical surgical resection or radiotherapy is performed in this group. But palliative internal fixation or radiotherapy for pain relief is permitted. Moreover, systemic chemotherapy, endocrine therapy and targeted therapy are allowed.

Experimental group：Radical local treatment. Radical resection is performed, and the cutting edge is negative, or radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). Systemic endocrine therapy and targeted therapy are allowed after radical local therapy. However, whether systemic chemotherapy should be used is determined by clinicians according to clinical experience or guidelines.

Вмешательства

• Процедура Radical resection
  Radical resection is performed, and the cutting edge is negative.
• Лучевая терапия Radical radiotherapy
  Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
• Другое Palliative treatment
  Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy

Первичные конечные точки

• Progression-free Survival (PFS) [Срок оценки: 4 years]

Вторичные конечные точки (2)

• Overall Survival (OS) [Срок оценки: 4 years]
• Patient Reported Outcomes [Срок оценки: 4 years]

Критерии участия

Критерии включения

• Patients provided written informed consent
• Women aged 18-75 years old
• Histologically confirmed breast cancer and after radical mastectomy
• Patients of breast cancer with ipsilateral humerus or sternum oligometastasis, and there is no imaging evidence of other site metastases
• Patients must have recovered to baseline condition or to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade = 1 from any acute CTCAE v. 5.0 grade =2 side effects of previous treatments
• Without infection of human immunodeficiency virus (HIV) on central laboratory assay results prior to randomization
• Alanine aminotransferase (ALT) </= 2.5 × the upper limit of normal (ULN), Aspartate aminotransferase (AST) </= 2.5 × ULN prior to randomization
• Total bilirubin (TBIL) </= 1.25 × ULN
• Alkaline phosphatase (ALK) </= 2.5 × ULN
• Gamma glutamyl transpeptidase (GGT) </= 2.5 × ULN
• Albumin >/= 30g/L
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
• Women of child-bearing age should take effective contraceptive measures
• Serum total bilirubin (TBil) </= 1.5 × ULN
• Serum creatinine (Scr) </= 1.5 × ULN
• White blood cell count (WBC) >/= 3×109/L, Blood neutrophil count >/= 1.5×109/L, Platelet count >/= 100×109/L, Hemoglobin (HB) >/= 9 g/dL

Критерии исключения

• Without radical mastectomy of the primary breast lesions
• No radical resection or radiotherapy is possible for metastatic lesions
• Other site metastases except ipsilateral humerus or sternum are present
• With multiple metastatic lesions
• Any other current malignancy or malignancy diagnosed within the past five years (other than carcinoma in situ or stage Ia carcinoma of the cervix, skin basal cell carcinoma and papillary thyroid carcinoma at early stage)
• Active infection with human immunodeficiency virus (HIV) prior to first study treatment administration.
• History of participating any other clinical trials within 30 days prior to randomization
• Known unable to tolerate humerus or sternal surgery or radical radiotherapy
• Pregnancy or lactation
• Current severe systemic disease (for example, clinically significant cardiovascular, pulmonary, or renal disease)
• Legal incompetence or limitation.
• Considered unable to complete the study or sign the informed consent due to a medical or mental disorder by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 4 центра

• Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University o — Ханчжоу
• The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) — Ханчжоу
• Jiaxing Second Hospital — Jiaxing
• The Central Hospital of Lishui — Lishui

Идентификаторы

NCT: NCT04158843 · BOMB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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