Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2022-06-30
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Choline
Choline with anti-PD-1 immunotherapy
Choline
Choline 300mg tid or 500mg bid, p.o
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Sodium cromoglicate
Sodium cromoglicate with anti-PD-1 immunotherapy
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Sodium Cromoglicate
Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Efavirenz
Efavirenz with anti-PD-1 immunotherapy
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Efavirenz
Efavirenz 600mg qd, p.o
HER2 low
HER2 low expression
SHR-A1811
4.8mg/kg q3w
SHR-1316
1200mg q3w
HER2 0
HER2 0 expression
SHR-A2102
6mg/kg q3w
SHR-1316
1200mg q3w
AK131
AK131(CD73/PD1 bispecific antibody)
AK131
AK131, 40mg/kg i.v., q2w
Mecapegfilgrastim
Mecapegfilgrastim with anti-PD-1 immunotherapy
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Mecapegfilgrastim
Mecapegfilgrastim, 6mg, d3, q3w, s.c.
Theophylline
Theophylline with anti-PD-1 immunotherapy
Theophylline
Theophylline, 100mg bid, p.o.
Interventions
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Choline
Choline 300mg tid or 500mg bid, p.o
anti-PD-1 antibody and chemotherapy
PD-1 antibody SHR1210 200mg q2w chemotherapy (whether and which should be given depends on the treatment regimen before enrollment)
Sodium Cromoglicate
Sodium Cromoglicate will be administered intranasally (nasal spray) (5 spray each nostril 4 times a day, 1 mg/spray)
Efavirenz
Efavirenz 600mg qd, p.o
SHR-A1811
4.8mg/kg q3w
SHR-A2102
6mg/kg q3w
SHR-1316
1200mg q3w
Mecapegfilgrastim
Mecapegfilgrastim, 6mg, d3, q3w, s.c.
AK131
AK131, 40mg/kg i.v., q2w
Theophylline
Theophylline, 100mg bid, p.o.
Eligibility Criteria
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Inclusion Criteria
* Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
* Radiologic/objective evidence of recurrence or disease progression after immunotherapy(combined with targeted therapy or chemo ) for metastatic breast cancer(MBC)
* Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
* have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
Exclusion Criteria
* Active or history of autoimmune disease or immune deficiency
* Significant cardiovascular disease
* History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
* Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment.
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* History of allergies to the drug components of this trial
* History of eosinophilosis or mastocytosis
* Patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past
* For the Mecapegfilgrastim group, patients had previously received PEG-rhG-CSF in combination with immunotherapy.
18 Years
70 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
Professor
Principal Investigators
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Zhimin Shao, Professor
Role: PRINCIPAL_INVESTIGATOR
Fudan U
Locations
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Fudan University Shanghai Cancer Center
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Wu SY, Jin X, Liu Y, Wang ZY, Zuo WJ, Ma D, Xiao Y, Fu T, Xiao YL, Chen L, Liu XY, Fan L, Wang ZH, Shen M, Liu R, Chai WJ, Shao ZM, Jiang YZ. Mobilizing antigen-presenting mast cells in anti-PD-1-refractory triple-negative breast cancer: a phase 2 trial. Nat Med. 2025 Jul;31(7):2405-2415. doi: 10.1038/s41591-025-03776-7. Epub 2025 Jun 25.
Other Identifiers
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2107239-9
Identifier Type: -
Identifier Source: org_study_id
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