Comparing radical and palliative treatments for breast cancer with specific bone metastases
A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis
This study is testing whether aggressive treatment for breast cancer with specific bone metastases can help patients feel better and live longer compared to just focusing on pain relief.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 183 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 4 sites (Hangzhou, Zhejiang and 3 other locations) |
| Trial ID | NCT04158843 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized, open-label study designed to evaluate the effectiveness of radical local treatment versus palliative treatment in breast cancer patients who have oligometastasis in the ipsilateral humerus or sternum. A total of 183 subjects will be randomly assigned to either an experimental group receiving radical resection or radiotherapy, or a control group receiving palliative care focused on pain relief. The study aims to determine the benefits of aggressive treatment in this specific patient population, with a focus on improving outcomes and quality of life.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-75 with histologically confirmed breast cancer and oligometastasis to the ipsilateral humerus or sternum, without evidence of metastases elsewhere.
Not a fit: Patients with extensive metastases beyond the humerus or sternum, or those with significant comorbidities that preclude aggressive treatment, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into whether radical treatment improves survival and quality of life for patients with oligometastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with radical treatment approaches in oligometastatic breast cancer, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hangzhou, Zhejiang and 3 other locations
- Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
- The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU) — Hangzhou, Zhejiang, China (Recruiting)
- Jiaxing Second Hospital — Jiaxing, Zhejiang, China (Not_yet_recruiting)
- The Central Hospital of Lishui — Lishui, Zhejiang, China (Not_yet_recruiting)
Study contacts
- Study coordinator: xuexin he, MD
- Email: xuexinhe@zju.edu.cn
- Phone: +86-18329139569
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.