TNBC - Triple-Negative Breast CancerPhase 2FUTURE-SUPERNCT04395989

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

A Phase 2 study testing A1: Pyrotinib with nab-paclitaxel, A2: nab-paclitaxel and B1: everolimus with nab-paclitaxel in people with TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: TNBC - Triple-Negative Breast Cancer
What is being tested?: A1: Pyrotinib with nab-paclitaxel, A2: nab-paclitaxel and B1: everolimus with nab-paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 139 participants
Where: 1 siteChina
Study dates: 28 Jul 2020to 31 Dec 2024
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

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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.

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

China1 site

Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: An Umbrella Trial Based on Molecular Pathway for Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer (FUTURE SUPER)

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

Read the detailed description

This is a Phase II, open-label, randomized controlled umbrella trial evaluating the efficacy and safety of multiple targeted treatment vs. traditional chemotherapy in patients with unresectable locally advanced or metastatic triple negative breast cancer. The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.These tests would be done on their rebiopsy tumor specimen. Specifically, as to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each TNBC subtype by applying an integrative analysis combining somatic mutation, copy number aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and FUSCC private TNBC database.

Conditions: TNBC - Triple-Negative Breast Cancer
Being tested: A1: Pyrotinib with nab-paclitaxel, A2: nab-paclitaxel, B1: everolimus with nab-paclitaxel, B2: nab-paclitaxel, C1: PD-1 with nab-paclitaxel and famitinib
Keywords: TNBC, Molecular Subtype, Precision Treatment, Umbrella Trial, First Line
Medical subject headings: Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

A1: Pyrotinib with nab-paclitaxelDrug
Also called SHR1258
A1: pyrotinib(EGFR-TKI) 400mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
A2: nab-paclitaxelDrug
A2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
B1: everolimus with nab-paclitaxelDrug
B1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
B2: nab-paclitaxelDrug
B2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
C1: PD-1 with nab-paclitaxel and famitinibDrug
Also called Camrelizumab, SHR1210
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
C2: nab-paclitaxelDrug
C2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabineDrug
Also called Bevacizumab (BP102)
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, with maintenance of capecitabineDrug
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 with nab-paclitaxelDrug
E1: everolimus 10mg po qd + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle
E2: nab-paclitaxelDrug
E2: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle

Study groups in NCT04395989
Study group	Role	What they receive
LAR-HER2mut	Experimental	If patients were LAR subtype with HER2 gene activated mutation Receives: Drug: A1: Pyrotinib with nab-paclitaxel; Drug: A2: nab-paclitaxel
LAR-PI3K/AKTmut	Experimental	If patients were LAR subtype without HER2 gene activated mutation, but had PI3K/AKT/mTOR pathway mutation Receives: Drug: B1: everolimus with nab-paclitaxel; Drug: B2: nab-paclitaxel
IM	Experimental	If patients were IM subtype (CD8 positive T cell more than 10%) Receives: Drug: C1: PD-1 with nab-paclitaxel and famitinib; Drug: C2: nab-paclitaxel
BLIS/MES-PI3K/AKTWT	Experimental	If patients were BLIS subtype or MES subtype without PI3K/AKT/mTOR pathway activation Receives: Drug: D1: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine; Drug: D2: nab-paclitaxel, with maintenance of capecitabine
MES-PI3K/AKTmut	Experimental	If patients were MES subtype and had PI3K/AKT/mTOR pathway activation Receives: Drug: E1: everolimus with nab-paclitaxel; Drug: E2: nab-paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS)
Refers to the time between the patient's enrollment and any recorded tumor progression or death from any cause.
Measured: approximately 3 years

Secondary outcomes (5)

Overall Survival (OS)
Refers to the period from the date of the first study dose to the date of death for any reason.
Measured: approximately 3 years
Objective response rate (ORR)
Defined as the proportion of patients whose tumors shrink to a certain amount and remain for a certain period of time, including cases of CR and PR.
Measured: approximately 3 years
Duration of Response (DoR)
Defined as the date from the first recording of tumor response (assessed according to RECIST 1.1) to the first recording of the objective progression of the tumor (assessed according to RECIST 1.1) or to the date of death for any reason, whichever occurs first.
Measured: approximately 3 years
Disease Control Rate (DCR)
The proportion of subjects who received treatment and whose best overall response (BOR) was assessed as complete response (CR), partial response (PR) and stable disease (SD) ≥4 weeks according to RECIST1.1.
Measured: approximately 3 years
Safety: Adverse Events (AE)
AE refers to any untoward medical occurrence in a study subject administered an investigational product which does not necessarily have a causal relationship with the treatment. AE is assessed according to the NCI-CTC AE 5.0.
Measured: approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jul 202031 Dec 2024

First posted20 May 2020
Study start28 Jul 2020
Primary completion31 May 2023
Study completion31 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Fudan UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 139 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04395989
Sponsor's protocol ID: SCHBCC-N031
Acronym: FUTURE-SUPER
Status last verified: Dec 2023
First submitted: 15 May 2020
Last updated: 22 Dec 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 38211606

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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