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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 The sponsor has not verified this record for over two years, so it may be out of date.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
Are there results?
None posted in the registry

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.

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 groupRoleWhat they receive
LAR-HER2mutExperimentalIf patients were LAR subtype with HER2 gene activated mutation
Receives: Drug: A1: Pyrotinib with nab-paclitaxel; Drug: A2: nab-paclitaxel
LAR-PI3K/AKTmutExperimentalIf 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
IMExperimentalIf 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/AKTWTExperimentalIf 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/AKTmutExperimentalIf 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.

  1. 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)

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted20 May 2020
  2. Study start28 Jul 2020
  3. Primary completion31 May 2023
  4. Study completion31 Dec 2024 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: approximately 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04395989, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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