An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.
FUTURE-SUPER
1 other identifier
interventional
139
1 country
1
Brief Summary
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2020
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 20, 2020
CompletedStudy Start
First participant enrolled
July 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedDecember 22, 2023
December 1, 2023
2.8 years
May 15, 2020
December 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.
approximately 3 years
Secondary Outcomes (5)
Overall Survival (OS)
approximately 3 years
Objective response rate (ORR)
approximately 3 years
Duration of Response (DoR)
approximately 3 years
Disease Control Rate (DCR)
approximately 3 years
Safety: Adverse Events (AE)
approximately 3 years
Study Arms (5)
LAR-HER2mut
EXPERIMENTALIf patients were LAR subtype with HER2 gene activated mutation
LAR-PI3K/AKTmut
EXPERIMENTALIf patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation
IM
EXPERIMENTALIf patients were IM subtype (CD8 positive T cell more than 10%)
BLIS/MES-PI3K/AKTWT
EXPERIMENTALIf patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation
MES-PI3K/AKTmut
EXPERIMENTALIf patients were MES subtype and had PI3K/AKT/mTOR pathway activation
Interventions
A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
C1: PD-1 antibody SHR1210 200mg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt + famitinib 20mg po qd, 4 weeks as a cycle
D1: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.
D2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks.
E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
Eligibility Criteria
You may qualify if:
- ECOG Performance Status of 0-1
- Expected lifetime of not less than three months
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
- Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection.
- Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
- Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm
- Have the cognitive ability to understand the protocol and be willing to participate and to be followed up.
You may not qualify if:
- Symptomatic, untreated, or actively progressing CNS metastases
- Active or history of autoimmune disease or immune deficiency
- Active hepatitis B or hepatitis C
- 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 taxel-based chemotherapy within 6 months
- Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded)within3 weeks prior to initiation of study treatment.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Previous received anti-VEGFR small molecule tyrosine kinase inhibitors (e.g. famitinib, sorafenib, Sunitinib, regorafenib, etc.) for treatment of the patients .
- A history of bleeding, any serious bleeding events.
- Important blood vessels around tumors has been infringed and high risk of bleeding.
- Long-term unhealing wound or incomplete healing of fracture
- Urine protein ≥2+ and 24h urine protein quantitative \> 1 g.
- Arrhythmia for long-term use of anti-arrhythmic drugs and New York heart association class II or higher cardiac insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
Study Sites (1)
Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
Related Publications (1)
Fan L, Wang ZH, Ma LX, Wu SY, Wu J, Yu KD, Sui XY, Xu Y, Liu XY, Chen L, Zhang WJ, Jin X, Xiao Q, Shui RH, Xiao Y, Wang H, Yang YS, Huang XY, Cao AY, Li JJ, Di GH, Liu GY, Yang WT, Hu X, Xia Y, Liang QN, Jiang YZ, Shao ZM. Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial. Lancet Oncol. 2024 Feb;25(2):184-197. doi: 10.1016/S1470-2045(23)00579-X. Epub 2024 Jan 8.
PMID: 38211606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of General Surgery of Fudan Shanghai Cancer Center
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 20, 2020
Study Start
July 28, 2020
Primary Completion
May 31, 2023
Study Completion
December 31, 2024
Last Updated
December 22, 2023
Record last verified: 2023-12