Breast CancerBOMBNCT04158843
Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
A study testing Radical resection, Radical radiotherapy and Palliative treatment in people with Breast Cancer and Oligometastasis, run by xuexin he at 4 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Oligometastasis
- What is being tested?
- Radical resection, Radical radiotherapy and Palliative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 4 sitesChina
- Study dates
- 9 May 2020to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Not yet recruiting
Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Gu Jin, MD, +86-0571-88122222
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, 310000
Xiaobo Yan, MD, +86-13588153306
xuexin he, MD, +86-18329139569
- Not yet recruiting
Jiaxing Second Hospital
Jiaxing, Zhejiang, 314000
Zhenhai Cai, MD, +86-0573-82080930
- Not yet recruiting
The Central Hospital of Lishui
Lishui, Zhejiang, 323000
Xiaoguang Wu, MD, +86-0578-2285777
About this study
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
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
Read the 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.
- Conditions
- Breast Cancer, Oligometastasis
- Being tested
- Radical resection, Radical radiotherapy, Palliative treatment
- Keywords
- Breast Cancer, Oligometastasis, Humerus, Sternum
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radical resectionProcedure or surgery
Radical resection is performed, and the cutting edge is negative.
Radical radiotherapyRadiation
Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
Palliative treatmentOther
Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy
| Study group | Role | What they receive |
|---|---|---|
| Radical local treatment | Experimental | 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. Receives: Procedure: Radical resection; Radiation: Radical radiotherapy |
| Palliative treatment | Active comparator | 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. Receives: Other: Palliative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as time from randomization to disease progression or death, whichever occurs first
Measured: 4 years
Secondary outcomes (2)
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.
Measured: 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])
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start9 May 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- xuexin he
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, xuexin he, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Xiaobo Yan, MD, Study director, The Second Affiliated Hospital of Zhejiang University School of Medicidne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04158843
- Sponsor's protocol ID
- BOMB
- Acronym
- BOMB
- Status last verified
- May 2020
- First submitted
- 7 Nov 2019
- Last updated
- 12 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04158843
- Acronym / sponsor ID
- BOMB / BOMB
- Conditions
- Breast Cancer, Oligometastasis
- Keywords
- Breast Cancer, Oligometastasis, Humerus, Sternum
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- xuexin heUniversity, hospital or other
- Study start
- 9 May 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radical local treatment | Experimental | Procedure: Radical resection, Radiation: Radical radiotherapyRadical 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. |
| Palliative treatment | Active comparator | Other: Palliative treatmentNo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radical resectionRadical resection is performed, and the cutting edge is negative. | Procedure or surgery | Radical local treatment |
| Radical radiotherapyRadical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). | Radiation | Radical local treatment |
| Palliative treatmentIncluding palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy | Other | Palliative treatment |
Primary outcome
Progression-free Survival (PFS)
Time frame: 4 years
PFS is defined as time from randomization to disease progression or death, whichever occurs first
2 secondary outcomes
Overall Survival (OS)
Time frame: 4 years
Patient Reported Outcomes
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaobo Yan, MD study director
The Second Affiliated Hospital of Zhejiang University School of Medicidne
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radical resection, Radical radiotherapy and Palliative treatment in people with Breast Cancer and Oligometastasis, run by xuexin he at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xuexin he, MD (+86-18329139569, xuexinhe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.