NCT04395989: FUTURE-SUPER

An Umbrella Trial Based on Molecular Pathway for Patients With Metastatic TNBC.

Status unknown Phase 2 Last updated 22 December 2023

What this trial tests

Phase 2 trial testing A1: Pyrotinib with nab-paclitaxel in TNBC - Triple-Negative Breast Cancer in 139 participants. Status unknown.

Timeline

28 July 2020

Primary endpoint
31 May 2023

31 December 2024

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	139
Start date	28 July 2020
Primary completion	31 May 2023
Estimated completion	31 December 2024
Sites	1 location across China

Drugs / interventions tested

• A1: Pyrotinib with nab-paclitaxel
• A2: nab-paclitaxel — full drug profile →
• B1: everolimus with nab-paclitaxel — full drug profile →
• B2: nab-paclitaxel
• C1: PD-1 with nab-paclitaxel and famitinib
• C2: nab-paclitaxel
• D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine — full drug profile →
• D2: nab-paclitaxel, with maintenance of capecitabine
• E1: everolimus with nab-paclitaxel — full drug profile →
• E2: nab-paclitaxel — full drug profile →

Conditions studied

• TNBC - Triple-Negative Breast Cancer — all drugs for TNBC - Triple-Negative Breast Cancer →

Sponsor

Fudan University

Who can join

Adults 18 to 70, female only, with TNBC - Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment in patients with metastaticTNBC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in therapeutic strategies for triple-negative breast cancer.
   Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
2. Heterogeneity of triple negative breast cancer: Current advances in subtyping and treatment implications.
   Asleh K, Riaz N, Nielsen TO. · · 2022 · cited 123× · PMID 36050786 · DOI 10.1186/s13046-022-02476-1
3. Famitinib with Camrelizumab and Nab-Paclitaxel for Advanced Immunomodulatory Triple-Negative Breast Cancer (FUTURE-C-Plus): An Open-Label, Single-Arm, Phase II Trial.
   Chen L, Jiang YZ, Wu SY, Wu J, et al · · 2022 · cited 81× · PMID 35247906 · DOI 10.1158/1078-0432.ccr-21-4313
4. Subtyping-based platform guides precision medicine for heavily pretreated metastatic triple-negative breast cancer: The FUTURE phase II umbrella clinical trial.
   Liu Y, Zhu XZ, Xiao Y, Wu SY, et al · · 2023 · cited 56× · PMID 36973538 · DOI 10.1038/s41422-023-00795-2
5. Optimising first-line subtyping-based therapy in triple-negative breast cancer (FUTURE-SUPER): a multi-cohort, randomised, phase 2 trial.
   Fan L, Wang ZH, Ma LX, Wu SY, et al · · 2024 · cited 50× · PMID 38211606 · DOI 10.1016/s1470-2045(23)00579-x
6. Current and future immunotherapy for breast cancer.
   Heater NK, Warrior S, Lu J. · · 2024 · cited 38× · PMID 39722028 · DOI 10.1186/s13045-024-01649-z
7. Agri-Food By-Products in Cancer: New Targets and Strategies.
   Sorrentino C, Di Gisi M, Gentile G, Licitra F, et al · · 2022 · cited 12× · PMID 36428610 · DOI 10.3390/cancers14225517
8. Improving efficacy of TNBC immunotherapy: based on analysis and subtyping of immune microenvironment.
   Yang Y, Li H, Yang W, Shi Y. · · 2024 · cited 11× · PMID 39430759 · DOI 10.3389/fimmu.2024.1441667