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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Oligometastasis
• Intervention / Treatment: Procedure: Radical resection; Radiation: Radical radiotherapy; Other: Palliative treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
      • Contact: Xiaobo Yan, MD; Phone Number: +86-13588153306
      • Contact: xuexin he, MD; Phone Number: +86-18329139569
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
      • Contact: Gu Jin, MD; Phone Number: +86-0571-88122222
    • Jiaxing, Zhejiang, China, 314000
      • Not yet recruiting
      • Jiaxing Second Hospital
      • Contact: Zhenhai Cai, MD; Phone Number: +86-0573-82080930
    • Lishui, Zhejiang, China, 323000
      • Not yet recruiting
      • The Central Hospital of Lishui
      • Contact: Xiaoguang Wu, MD; Phone Number: +86-0578-2285777

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Radical resection; Radical resection is performed, and the cutting edge is negative.; Radiation: Radical radiotherapy; Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
Active Comparator: Palliative treatment; No radical surgical resection or 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.	Other: Palliative treatment; Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	PFS is defined as time from randomization to disease progression or death, whichever occurs first	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as time from randomization to death for any cause. If there is no death reported for a subject before the date cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive. For patients who had not died up to the cut-off date, the date they were last known to be alive was derived from the patient status records, the trial completion record, radiological imaging assessments, the study treatment termination record, and the randomization date.	4 years
Patient Reported Outcomes	Breast cancer specific health treatment related quality of life and general health status (Functional Assessment of Cancer Therapy-Breast (FACT-B) [version 4])	4 years

Collaborators and Investigators

• Sponsor: xuexin he
• Investigators: Study Director: Xiaobo Yan, MD, The Second Affiliated Hospital of Zhejiang University School of Medicidne

Study record dates

Study Major Dates

• Study Start (Anticipated): May 9, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 12, 2019

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Breast Cancer; Humerus; Oligometastasis; Sternum
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: BOMB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No