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Breast CancerPhase 1/2NCT04582968

Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

A Phase 1/2 study testing Pyrotinib Plus Capecitabine combined with brain radiotherapy in people with Breast Cancer and Brain Metastases, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pyrotinib Plus Capecitabine combined with brain radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
2 Jan 2020to 12 Aug 2023
Phase
Phase 1/2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically confirmed HER2 positive advanced breast cancer
  • Age>18 years. brain metastases confirmed by enhanced brain MRI
  • KPS≥70
  • Life expectancy of more than 12 weeks
  • Prior therapy of oral dexamethasone not exceeding 16mg/d
  • Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
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  • Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)
  • Prior endocrine therapy were allowed
  • Anti-Her2 targeted treatment were allowed
  • Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
  • Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
  • Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
  • LVEF ≥ 50%
  • QTcF < 480 ms
  • INR≤1.5×ULN，APTT≤1.5×ULN
  • Signed the informed consent form prior to patient entry

Who cannot join

  • Leptomeningeal or hemorrhagic metastases
  • uncontrolled epilepsy
  • Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.
  • Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
  • Inability to complete enhanced MRI
  • Patients who are difficult or unable to be followed-up
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  • Not suitable for inclusion for specific reasons judged by sponsor
  • Patients unable to swallow, with chronic diarrhea, intestinal obstruction, or multiple factors that affect drug use and absorption
  • History of allergy to pyrotinib or capetabine
  • History of immunodeficiency, including HIV positive, active HBV/HCV or other acquired, congenital immunodeficiency disease, or organ transplantation history
  • Previous use of pyrotinib combined with capetabine

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

Other trials in China

About this study

Official title: A Phase Ib/II Pilot Study of Pyrotinib Plus Capecitabine Combined With Brain Radiotherapy in HER2 Positive Breast Cancer Patients With Brain Metastases

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.

Being tested
Pyrotinib Plus Capecitabine combined with brain radiotherapy
Keywords
pyrotinib, brain radiotherapy
Medical subject headings
Breast Neoplasms, Brain Neoplasms

What participants receive

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

  • Pyrotinib Plus Capecitabine combined with brain radiotherapyOther

    Drug combined with radiation

Study groups in NCT04582968
Study groupRoleWhat they receive
Pyrotinib Plus Capecitabine combined with brain radiotherapyExperimentalFractionated stereotactic radiotherapy(FSRT) or whole brain radiation therapy (WBRT) Drug: Pyrotinib combined with capecitabine pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
Receives: Other: Pyrotinib Plus Capecitabine combined with brain radiotherapy

What is being measured

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

  1. Assess safety and tolerability of Pyrotinib Plus Capecitabine combined with brain radiotherapy(Phase Ib part)

    AEs will be assessed according to CTCAE version 4.03.

    (1)Initially 3 patients will be accrued and treated with combined therapy as a lead-in safety phase. Enrollment of the study will not proceed if patients in the safety lead-in phase experience unacceptable toxicities including neurologic, hematologic and other dose limiting toxicities.(see protocol) (b)If one of initially 3 patients has experienced unacceptable toxicities, 3 more patients will be accrued .

    (3)If two or more patients are unable to complete radiation therapy (RT) due to toxicity related to Pyrotinib Plus Capecitabine combined with brain radiotherapy, accrual will be suspended and the study will be stopped.

    (4) If 3+3 patients are able to complete the treatment without unacceptable toxicities, 6 more patients will be accrued in Ib part.

    Measured: 8 weeks

  2. Intracranial local tumor control rate （Phase II part)

    All intracranial progression

    Measured: 2 years

Secondary outcomes (4)

  1. Intracranial local tumor control rate with FSRT or WBRT

    Intracranial local tumor control rate

    Measured: 2 years

  2. Intracranial Progression-Free Survival (PFS)

    Time from the date of radiotherapy to the investigator-determined date of progression (determined by RANO) or death due to any cause, whichever occurs first

    Measured: 2 years

  3. Extracranial Progression-Free Survival (PFS)

    Measured: 2 years

  4. OS (overall survival)

    Measured: 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 posted12 Oct 2020
  2. Study start2 Jan 2020
  3. Primary completion12 Aug 2022
  4. Study completion12 Aug 2023 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04582968
Sponsor's protocol ID
FDRT-BC010
Status last verified
Jan 2023
First submitted
7 Oct 2020
Last updated
18 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dai L, Gao T, Guo R, Chen Y, Wang J, Zhou S, Tang Y, Chen D, Huang S. Efficacy and safety of pyrotinib-based regimens in HER2 positive metastatic breast cancer: A retrospective real-world data study. Neoplasia. 2024 Oct;56:101029. doi: 10.1016/j.neo.2024.101029. Epub 2024 Jul 17.

    PubMed 39024777

  • Yang Z, Meng J, Mei X, Mo M, Xiao Q, Han X, Zhang L, Shi W, Chen X, Ma J, Palmer J, Shao Z, Zhang Z, Yu X, Guo X. Brain Radiotherapy With Pyrotinib and Capecitabine in Patients With ERBB2-Positive Advanced Breast Cancer and Brain Metastases: A Nonrandomized Phase 2 Trial. JAMA Oncol. 2024 Mar 1;10(3):335-341. doi: 10.1001/jamaoncol.2023.5791.

    PubMed 38175627

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pyrotinib Plus Capecitabine combined with brain radiotherapy in people with Breast Cancer and Brain Metastases, 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 17 inclusion and 11 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 18 Jan 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Assess safety and tolerability of Pyrotinib Plus Capecitabine combined with brain radiotherapy(Phase Ib part) (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT04582968, which also lists 2 linked publications.

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 18 Jan 2023.

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