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HER2 Positive Metastatic Breast CancerPhase 2NCT03691051

A Study of Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer

A Phase 2 study testing Pyrotinib plus Capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Henan Cancer Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from HER2-positive metastatic breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2 Positive Metastatic Breast Cancer
What is being tested?
Pyrotinib plus Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
20 Nov 2018to 30 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥ 18 years old at the time of signing the informed consent form.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • HER2-positive: In the pathological examination/rechecking of primary lesions or metastatic lesions performed by the Research site's Pathology Laboratory, at least once the tumor cells defined as 3+ staining by immunohistochemistry, or fluorescence in situ hybridization [FISH] confirmed positive
  • MRI/enhanced CT confirmed brain metastasis. According to RECIST 1.1, there is at least one measurable brain lesion, and the measurability of extracranial lesions is not required
  • Patients Group Cohort A: participants with brain metastases who have not previously been treated with CNS radiotherapy, it should be more than two weeks since the end of the last systemic treatment. Patients with new brain lesions after craniotomy are allowed to be included, provided that they have not received radiotherapy after surgery and are at least 2 weeks away from surgery.
  • Cohort B: Patients with disease progression or new lesions after whole brain radiotherapy (WBRT) or stereotactic radiotherapy (SRT); For lesions that have received local treatment, there is clear evidence of progress in imaging examination, and the lesions that have undergone radiotherapy can be selected as target lesions. If a patient has multiple CNS lesions, only one or a few of which are treated with SRT, and there are lesions that are not treated locally, such patients are still eligible for enrollment in this study.
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  • Previous treatment
  • Acceptable previous treatments:
  • History of trastuzumab and other anti-HER2 macromolecular antibodies. Any lines of previous chemotherapy. History of endocrine therapy. Patients who have not used capecitabine except for patients with progression at least 6 (for metastatic disease) or 12 (as adjuvant therapy) months after discontinuation of a capecitabine-containing treatment.
  • Concurrent use of bisphosphonates, mannitol and glucocorticoids is allowed, provided that the dosage(⩽2 mg dexamethasone (or equivalent) per day) of glucocorticoids is stable for at least one week before enrollment.
  • Expected to survival ≥ 6 months
  • Patients must have adequate organ function, criteria as follows.
  • Blood routine examination：Absolute Neutrophil Count (ANC)≥1.0×109/L； PLT ≥100×109/L； Hb ≥90g/L
  • Blood chemistry test：TBIL ≤1.5 times the upper limit of normal (ULN); ALT and AST≤3 times ULN; For patients with liver metastases, ALT and AST≤5×ULN; BUN and Cr≤1×ULN and creatinine clearance ≥50mL/min (CockcroftGault formula);
  • Ultrasonic cardiogram: LVEF≥50%
  • 12-lead ECG: The QT interval (QTcF) corrected by Fridericia's method is < 450 ms/man and < 470 ms/women.
  • Patients need to voluntarily join this study after they fully understand and sign the informed consent form. Patients need to have good compliance and be willing to cooperate with follow-up.

Who cannot join

  • Patients with leptomeningeal metastasis (diagnosed by imaging/positive cerebrospinal fluid cytology) or a clear indication of clinically significant leptomeningeal involvement;
  • CNS complications that require urgent neurosurgical intervention (e.g. resection, shunt placement). Patients with poorly response brain metastases after dehydration treatment and glucocorticoid treatment. Such as uncontrollable increase in intracranial pressure, jet vomiting, mental disorders, epilepsy, cognitive impairment, etc.
  • Third space fluid that cannot be controlled by drainage or other methods (such as large amounts of pleural fluid and ascites);
  • Patients who have received chemotherapy, surgery or molecular targeted therapy within 2 weeks before enrollment; patients who have received endocrine therapy within 1 week before enrollment; minor surgery, such as tumor biopsy, thoracentesis or intravenous catheterization or the like are allowed;
  • Participated in other clinical trial within 4 weeks prior to randomization.
  • Concurrent treated, or who has been treated with HER2 tyrosine kinase inhibitors (including lapatinib, neratinib, pyrotinib, etc.);
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  • History of other malignant tumors within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma;
  • Receiving any other anti-tumor therapies at time of study screening visit.
  • There are serious and/or uncontrolled complications that may affect participation, including any of the following:
  • dysphagia, chronic diarrhea and intestinal obstruction and factors that affect the administration and absorption of the drug;
  • Allergic constitution; Allergic to the study drug; History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases; History of organ transplantation;
  • History of severe heart disease, including: myocardial infarction and heart failure; any other heart disease that is not suitable for participation (investigator assessment);
  • Infection.
  • Female patients during pregnancy and lactation; fertile female patients who tested positive on a baseline pregnancy test; female patients of childbearing age who are unwilling to take effective contraceptive measures during the trial.
  • Any other circumstances that are not suitable for inclusion in this study (investigator assessment)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Pyrotinib Plus Capecitabine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Single-arm, Open-label, Ahead Study

Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors.This study is a single-arm, prospective, open label clinical study of pyrotinib plus capecitabine as the Therapy of brain metastases from HER2-positive metastatic breast cancer.

Read the detailed description

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. In the case of solitary brain metastases, surgery or stereotactic radiosurgery are the preferred therapeutic approaches.Chemotherapy is used after further progression of disease but it has limited effectiveness. In HER2-positive tumours, trastuzumab therapy has been postulated to be associated with an increased risk of development of brain metastases.Thus new therapeutic options are urgently needed to improve patients'outcome. Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. We designed the study to explore the possibility of pyrotinib plus capecitabine for brain metastases from HER2-positive metastatic breast cancer.

Being tested
Pyrotinib plus Capecitabine

What participants receive

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

  • Pyrotinib plus CapecitabineDrug

    Also called Irene

    Pyrotinib:400mg/d,q.d.,p.o. A course of treatment need 21days. Capecitabine:1000mg/m2,bid,from day1-day14, A course of treatment need 21 days.

Study groups in NCT03691051
Study groupRoleWhat they receive
Pyrotinib Plus CapecitabineExperimentalPyrotinib + Capecitabine
Receives: Drug: Pyrotinib plus Capecitabine

What is being measured

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

  1. Objective Response Rate of Intracranial Lesion (ORR)

    the proportion of patients with the best intracranial response of confirmed complete or partial response according to RECIST 1·1, as assessed by the investigator

    Measured: Estimated up to 1 year

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    time from the first dose to disease progression or any-cause death

    Measured: Estimated up to 3 year

  2. Objective Response Rate of Extracranial Lesion (ORR)

    proportion of patients with confirmed extracranial complete or partial response per RECIST 1·1

    Measured: Estimated up to 1 year

  3. Duration of response (DOR)

    time from the first documented intracranial objective response to intracranial or extracranial disease progression in patients with confirmed response

    Measured: Estimated up to 1 year

  4. Overall survival（OS）

    time from the first dose of study drug to any-cause death

    Measured: Estimated up to 3 year

Timeline

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

  1. First posted1 Oct 2018
  2. Study start20 Nov 2018
  3. Primary completion16 Apr 2021
  4. Study completion30 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03691051
Sponsor's protocol ID
HR-MBC-HN001
Status last verified
Sep 2023
First submitted
28 Sep 2018
Last updated
25 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in this article, after de-identificationare available following article publication.

Publications

  • Yan M, Ouyang Q, Sun T, Niu L, Yang J, Li L, Song Y, Hao C, Chen Z, Liu Z, Lv H, Zhang M, Liu L, Yang X, Xiao H, Gao Z, Li X, Dong F, Zhang L, Dong D, Chen X, Qiao J, Zhang G, Zeng H, Wang J, Sun H, Feng Y, Chen Y, Xia F. Pyrotinib plus capecitabine for patients with HER2-positive metastatic breast cancer and brain metastases (PERMEATE trial): overall survival results from a multicenter, single-arm, two-cohort, phase 2 trial. EClinicalMedicine. 2024 Sep 20;76:102837. doi: 10.1016/j.eclinm.2024.102837. eCollection 2024 Oct.

    PubMed 39380967

  • Yan M, Ouyang Q, Sun T, Niu L, Yang J, Li L, Song Y, Hao C, Chen Z, Orlandi A, Ishii N, Takabe K, Franceschini G, Ricci F, Verschraegen C, Liu Z, Zhang M, Lv H, Liu L, Yang X, Xiao H, Gao Z, Li X, Dong F, Chen X, Qiao J, Zhang G. Pyrotinib plus capecitabine for patients with human epidermal growth factor receptor 2-positive breast cancer and brain metastases (PERMEATE): a multicentre, single-arm, two-cohort, phase 2 trial. Lancet Oncol. 2022 Mar;23(3):353-361. doi: 10.1016/S1470-2045(21)00716-6. Epub 2022 Jan 31.

    PubMed 35085506

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib plus Capecitabine in people with HER2 Positive Metastatic Breast Cancer, run by Henan Cancer Hospital 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 15 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 25 Sep 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?

Objective Response Rate of Intracranial Lesion (ORR) (time frame: Estimated up to 1 year). 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 NCT03691051, 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 25 Sep 2023.

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