Back to resultsRadical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis (BOMB)
Primary Purpose
Breast Cancer, Oligometastasis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Radical resection
Radical radiotherapy
Palliative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Oligometastasis, Humerus, Sternum
Eligibility 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.
Sites / Locations
- Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)Recruiting
- Jiaxing Second Hospital
- The Central Hospital of Lishui
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Radical local treatment
Palliative treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Progression-free Survival (PFS)
PFS is defined as time from randomization to disease progression or death, whichever occurs first
Secondary Outcome Measures
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.
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])
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04158843
Brief Title
Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
Acronym
BOMB
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 9, 2020 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
xuexin he
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Oligometastasis
Keywords
Breast Cancer, Oligometastasis, Humerus, Sternum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radical local treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Palliative treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radical resection
Intervention Description
Radical resection is performed, and the cutting edge is negative.
Intervention Type
Radiation
Intervention Name(s)
Radical radiotherapy
Intervention Description
Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
Intervention Type
Other
Intervention Name(s)
Palliative treatment
Intervention Description
Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
PFS is defined as time from randomization to disease progression or death, whichever occurs first
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
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.
Time Frame
4 years
Title
Patient Reported Outcomes
Description
Breast cancer specific health treatment related quality of life and general health status (Functional Assessment of Cancer Therapy-Breast (FACT-B) [version 4])
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuexin he, MD
Phone
+86-18329139569
Email
xuexinhe@zju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaobo Yan, MD
Organizational Affiliation
The Second Affiliated Hospital of Zhejiang University School of Medicidne
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gu Jin, MD
Phone
+86-0571-88122222
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobo Yan, MD
Phone
+86-13588153306
First Name & Middle Initial & Last Name & Degree
xuexin he, MD
Phone
+86-18329139569
Facility Name
Jiaxing Second Hospital
City
Jiaxing
State/Province
Zhejiang
ZIP/Postal Code
314000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhenhai Cai, MD
Phone
+86-0573-82080930
Facility Name
The Central Hospital of Lishui
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoguang Wu, MD
Phone
+86-0578-2285777
12. IPD Sharing Statement
Learn more about this trial
Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
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