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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04158843
Recruitment Status : Recruiting
First Posted : November 12, 2019
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
xuexin he, Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breast Cancer Oligometastasis Procedure: Radical resection Radiation: Radical radiotherapy Other: Palliative treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis
Estimated Study Start Date : May 9, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 4 years ]
    PFS is defined as time from randomization to disease progression or death, whichever occurs first


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 4 years ]

    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.


  2. Patient Reported Outcomes [ Time Frame: 4 years ]
    Breast cancer specific health treatment related quality of life and general health status (Functional Assessment of Cancer Therapy-Breast (FACT-B) [version 4])



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04158843


Contacts
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Contact: xuexin he, MD +86-18329139569 xuexinhe@zju.edu.cn

Locations
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China, Zhejiang
Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Gu Jin, MD    +86-0571-88122222      
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xiaobo Yan, MD    +86-13588153306      
Contact: xuexin he, MD    +86-18329139569      
Jiaxing Second Hospital Not yet recruiting
Jiaxing, Zhejiang, China, 314000
Contact: Zhenhai Cai, MD    +86-0573-82080930      
The Central Hospital of Lishui Not yet recruiting
Lishui, Zhejiang, China, 323000
Contact: Xiaoguang Wu, MD    +86-0578-2285777      
Sponsors and Collaborators
xuexin he
Investigators
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Study Director: Xiaobo Yan, MD The Second Affiliated Hospital of Zhejiang University School of Medicidne
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Responsible Party: xuexin he, Associate chief physician, Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04158843    
Other Study ID Numbers: BOMB
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by xuexin he, Second Affiliated Hospital, School of Medicine, Zhejiang University:
Breast Cancer
Oligometastasis
Humerus
Sternum
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases