Clinical trial · Interventional
An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.
An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)
NCT04395989CI-TRIAL-00072492FUTURE-SUPERunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| TNBC - Triple-Negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| A1: Pyrotinib with nab-paclitaxel | Drug | — | UNRESOLVED |
| A2: nab-paclitaxel | Drug | — | UNRESOLVED |
| B1: everolimus with nab-paclitaxel | Drug | — | UNRESOLVED |
| B2: nab-paclitaxel | Drug | — | UNRESOLVED |
| C1: PD-1 with nab-paclitaxel and famitinib | Drug | — | UNRESOLVED |
| C2: nab-paclitaxel | Drug | — | UNRESOLVED |
| D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine | Drug | — | UNRESOLVED |
| D2: nab-paclitaxel, with maintenance of capecitabine | Drug | — |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- LAR-HER2mut
- description
- If patients were LAR subtype with HER2 gene activated mutation
- interventionNames
- Drug: A1: Pyrotinib with nab-paclitaxel
- Drug: A2: nab-paclitaxel
- type
- EXPERIMENTAL
- label
- LAR-PI3K/AKTmut
- description
- If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation
- interventionNames
- Drug: B1: everolimus with nab-paclitaxel
- Drug: B2: nab-paclitaxel
- type
- EXPERIMENTAL
- label
- IM
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDFan 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 38211606