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HER2-positive Metastatic Breast CancerPhase 2NCT05042791

A Study of Pyrotinib Plus Capecitabine Combined With SRT in HER2+ MBC With Brain Metastases

A Phase 2 study testing radiation combined with pyrotinib and capecitabine in people with HER2-positive Metastatic Breast Cancer, run by Jiangxi Provincial 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-positive Metastatic Breast Cancer
What is being tested?
radiation combined with pyrotinib and capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
362 participants
Where
1 siteChina
Study dates
1 Mar 2022to 30 Sep 2025
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age> 18 years old, female
  • KPS≥70
  • HER2-positive breast cancer is confirmed by the pathology laboratory with an immunohistochemical (IHC) score of 3+ and/or 2+ and a positive in situ hybridization (ISH) test (ISH amplification rate ≥ 2.0)
  • Brain metastasis confirmed by MRI, in line with the indications for whole brain radiotherapy
  • At least one measurable brain lesion exists according to the RECIST 1.1 standard
  • Unlimited number of previous chemotherapy lines
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  • Have not used capecitabine in the past, or progressed 6 months after capecitabine stopped, or progressed after capecitabine as adjuvant therapy stopped for one year
  • The expected survival period is more than 12 weeks
  • Patients must have adequate organ function, criteria as follows.
  • Blood routine examination：Absolute Neutrophil Count (ANC)≥1.5×109/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 < 470 ms
  • Patients with known hormone receptor status
  • 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 brain metastases with extensive meningeal metastasis
  • Brain metastases within 5 mm of the hippocampus
  • There are many factors that affect the administration and absorption of drugs, for example: inability to swallow, chronic diarrhea and intestinal obstruction
  • Those who have received chemotherapy, surgical treatment (excluding local puncture) or molecular targeted therapy within 4 weeks before enrollment; those who have received anti-tumor endocrine therapy after the screening period
  • Participated in other drug clinical trials within 4 weeks before enrollment
  • Have used or are currently using HER2 tyrosine kinase inhibitors (lapatinib, niratinib, pyrotinib, etc.)
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  • Suffered from other malignant tumors in the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma
  • Receive any other anti-tumor therapy at the same time
  • Those who are known to have a history of allergies to the drug; have a history of immunodeficiency, including positive HIV tests, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplants history
  • Have ever suffered from any heart disease, including: (1) arrhythmia requiring medication or clinical significance; (2) myocardial infarction; (3) heart failure; (4) anyone judged by the researcher as unsuitable for participation becase of other heart diseases in this trial, etc.
  • Female patients during pregnancy and lactation, female patients with fertility and a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period
  • According to the judgment of the investigator, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.)
  • The patient has not recovered from the toxicity of the previous treatment to grade 0-1 (except for hair loss)
  • Have a clear history of neurological or psychiatric disorders, including epilepsy or dementia
  • Concomitant use of CYP3A4 inhibitors or inducers or drugs that prolong the QT interval
  • Any other circumstances that are not suitable for inclusion in this study (investigator assessment)

Trial locations and contacts

1 site in 1 country.

Chunling no Jiang, Dr. contact

+86 13979109200

jclil2002@163.com

China1 site, 1 recruiting

  • Jiangxi Cancer Hospital of Nanchang University

    Nanchang, Jiangxi, 330029

    Chunling Jiang, MD,PHD, +8613979109200, jclil2002@163.com

    Recruiting

Other trials in China

About this study

Official title: SRT Versus WBRT Combined With Pyrrotinib and Capecitabine in the Treatment of HER2-positive Advanced Breast Cancer Patients With Brain Metastases: A Randomized Controlled, Prospective Clinical Study

This study evaluates the efficacy and safety of SRT combined with pyrotinib and capecitabine in the treatment of patients with HER2-positive advanced breast cancer patients with brain metastases.

Read the detailed description

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. In the case of multiple brain metastases, radiation therapy is the preferred therapeutic approaches. However, the side effects of WBRT for long-lived patients are also obvious, such as irreversible decline in cognitive function and decline in memory function. WBRT can also cause extensive hair loss and extensive white matter lesions on imaging. Pyrotinib as an oral tyrosine kinase inhibitor has good efficacy and safety in patients with breast cancer brain metastases. Therefore, in order to reduce the impact of WBRT on the cognitive function, a phase II clinical study of SRT versus WBRT combined with pyrotinib and capecitabine in the treatment of MBC with brain metastases was carried out to explore the efficacy and safety of radiotherapy de-escalation therapy.

Being tested
radiation combined with pyrotinib and capecitabine

What participants receive

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

  • radiation combined with pyrotinib and capecitabineCombination product

    This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases

Study groups in NCT05042791
Study groupRoleWhat they receive
SRT combined with pyrotinib and capecitabineExperimentalSRT: SRT needs to be comprehensively considered based on the size, number, and location of the lesion, and SRS and FSRT are performed according to clinical needs. 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.
Receives: Combination Product: radiation combined with pyrotinib and capecitabine
WBRT combined with pyrotinib and capecitabineActive comparatorWBRT: WBRT need to be considered based on the size, number, and location of the lesion. 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.
Receives: Combination Product: radiation combined with pyrotinib and capecitabine

What is being measured

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

  1. CNS-ORR

    Objective response rate of central nervous system

    Measured: Estimated up to 1 year

Timeline

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

  1. First posted13 Sep 2021
  2. Study start1 Mar 2022
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion30 Sep 2025 (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
362 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042791
Sponsor's protocol ID
20210901-jiangchunling
Status last verified
Feb 2024
First submitted
6 Sep 2021
Last updated
9 Feb 2024
Results posted
No
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing radiation combined with pyrotinib and capecitabine in people with HER2-positive Metastatic Breast Cancer, run by Jiangxi Provincial 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 15 inclusion and 16 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 9 Feb 2024. 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?

Contact Chunling no Jiang, Dr. (+86 13979109200, jclil2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CNS-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 NCT05042791, 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 9 Feb 2024.

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