Actively Recruiting
Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
Led by xuexin he · Updated on 2020-05-12
183
Participants Needed
4
Research Sites
346 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 75 years old
- Provided written informed consent
- Histologically confirmed breast cancer after radical mastectomy
- Breast cancer with ipsilateral humerus or sternum oligometastasis only, no other metastases seen in imaging
- Recovered to baseline condition or mild side effects (CTCAE v5.0 grade 1) from previous treatments
- Negative for HIV infection by lab test before randomization
- Liver function tests within defined safe limits (ALT, AST </= 2.5x ULN; TBIL </= 1.25x ULN; ALK, GGT </= 2.5x ULN)
- Albumin level >/= 30 g/L
- ECOG performance status 0 to 2
- Women of child-bearing age using effective contraception
- Kidney function tests within defined safe limits (TBil </= 1.5x ULN; Scr </= 1.5x ULN)
- Adequate blood counts (WBC >/= 3x10^9/L; neutrophils >/= 1.5x10^9/L; platelets >/= 100x10^9/L; hemoglobin >/= 9 g/dL)
You will not qualify if you...
- No radical mastectomy of primary breast lesions
- Metastatic lesions not suitable for radical resection or radiotherapy
- Presence of metastases in sites other than ipsilateral humerus or sternum
- Multiple metastatic lesions
- Other current malignancies or cancer diagnosed within past 5 years except certain early-stage cancers
- Active HIV infection before study treatment
- Participation in another clinical trial within 30 days before randomization
- Unable to tolerate humerus or sternal surgery or radical radiotherapy
- Pregnancy or breastfeeding
- Severe systemic diseases (like serious heart, lung, or kidney disease)
- Legal incompetence or limitations
- Medically or mentally unable to complete study or provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Institute of Cancer Research and Basic Medical Sciences, CAS Cancer Hospital, University of Chinese Academy of Sciences Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310000
Not Yet Recruiting
2
The Second Affiliated Hospital of Zhejiang University School of Medicine (SAHZU)
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
3
Jiaxing Second Hospital
Jiaxing, Zhejiang, China, 314000
Not Yet Recruiting
4
The Central Hospital of Lishui
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
Research Team
X
xuexin he, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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