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HER2-positive Advanced Breast CancerPhase 2NCT04903652

Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer

A Phase 2 study testing Pyrotinib Maleate and Vinorelbine in people with HER2-positive Advanced Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-positive Advanced Breast Cancer
What is being tested?
Pyrotinib Maleate and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
1 Jan 2021to 6 Feb 2022
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

  • Female patients between 18 and 75 years old;
  • ECOG physical status score 0-2 points;
  • The expected overall survival period is not less than 12 weeks;
  • Pathologically confirmed HER2 expression-positive recurrent/metastatic breast cancer patients; the standard for HER2 expression positive is immunohistochemical staining (IHC) detection of HER2 3+ and/or fluorescent in situ hybridization (FISH) positive The researcher of the test center reviews and confirms).
  • The disease progresses during or after treatment with trastuzumab (stopping the drug for less than 12 months);
  • The number of chemotherapy lines used in the recurrence/metastasis stage is less than or equal to 2 lines;
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  • Patients who have at least one measurable lesion [spiral CT scan ≥10 mm (CT scan thickness not greater than 5mm)] and who have progressed after or during the last anti-tumor treatment (RECIST version 1.1);
  • The main organs are functioning normally, that is, they meet the following standards:
  • 1) The standard of routine blood examination should meet: Hb≥100 g/L (no blood transfusion within 14 days); ANC≥1.5×109 /L; PLT≥75×109 /L; 2) The biochemical inspection shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Serum creatinine ≤1.5×ULN, creatinine clearance ≥50ml/min (based on Cockroft and Gault formula); 3) Heart color Doppler ultrasound Left ventricular ejection fraction (LVEF) ≥50%; 9. For female patients who have not undergone menopause or have not undergone surgical sterilization: during treatment and at least 7 months after the last dose in the study treatment, agree to abstain from sex or use an effective method of contraception. 10. Patients voluntarily join this study, have good compliance with the planned treatment, understand the research process of this study, and sign written informed consent.

Who cannot join

  • There is fluid in the third space that cannot be controlled by drainage or other methods, such as pleural fluid and ascites;
  • There are many factors that affect the oral and absorption of drugs (such as inability to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
  • Severe heart disease or discomfort, including but not limited to the following diseases:
  • Confirmed history of heart failure or systolic dysfunction (LVEF <50%)
  • High-risk uncontrolled arrhythmia, such as atrial tachycardia, resting heart rate> 100 bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher grade atrioventricular block (ie Mobitz II second degree atrioventricular block or third degree atrioventricular block)
  • Angina pectoris that requires anti-angina pectoris medication
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  • Clinically significant heart valve disease
  • ECG shows transmural myocardial infarction -Poor hypertension control (systolic blood pressure> 180 mmHg and/or diastolic blood pressure> 100 mmHg).
  • Those who have been confirmed to be allergic to the drug components of this program; have a history of immunodeficiency, including positive HIV testing, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation.
  • Patients who are known to be pregnant or planning to become pregnant, or patients of gestational age who are unwilling to take effective contraceptive measures during the entire trial period;
  • Suffer from serious concomitant diseases, such as infectious diseases.
  • Other malignant tumors have occurred in the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer;
  • Patients who have participated in other experimental studies within 30 days before the first dose of study drug is administered;
  • Patients judged by the investigator to be unsuitable to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Cancer Hospital

    Tianjin

Other trials in China

About this study

Official title: A Prospective Phase Ⅱ Clinical Study of Pyrotinib Maleate Combined With Vinorelbine in the Treatment of HER2-positive Advanced Breast Cancer That Has Failed Trastuzumab Therapy

This study is a single-center, single-arm, prospective phase II clinical study, which mainly evaluates the efficacy and safety of pyrotinib maleate combined with oral vinorelbine in the treatment of HER2-positive advanced breast cancer.

Read the detailed description

The most important treatment for HER2-positive breast cancer is based on anti-HER2 targeted therapy, combined with chemotherapy or endocrine therapy. China's original new anti-HER2 targeted therapy drug, pyrotinib, has obtained rapid approval from the country for its outstanding phase II clinical trial efficacy. In patients enrolled in the phase II trial, pyrotinib has a significant effect, but the combination of pyrotinib and capecitabine significantly increases the adverse reactions of diarrhea. For this reason, there is a lack of research on other combination schemes of pyrotinib in HER2 advanced breast cancer. In the first-line treatment, the combination therapy (HN) of trastuzumab and vinorelbine has shown that it also has a synergistic effect with vinorelbine in anti-HER2 targeted therapy. It provides a good evidence-based basis for the trial design of pyrotinib combined with vinorelbine soft capsules. This phase II clinical study is specially designed for preliminary exploration.

Being tested
Pyrotinib Maleate, Vinorelbine

What participants receive

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

  • Pyrotinib MaleateDrug

    Pyrotinib p.o. 400 mg once daily

  • VinorelbineDrug

    Vinorelbine p.o. 40 mg once every other day

Study groups in NCT04903652
Study groupRoleWhat they receive
Pyrotinib plus VinorelbineExperimentalNot described
Receives: Drug: Pyrotinib Maleate; Drug: Vinorelbine

What is being measured

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

  1. Progression-free survival (PFS)

    From enrollment to progression or death (for any reason)

    Measured: Estimated 24 months

Secondary outcomes (4)

  1. Objective response rate (ORR)

    Ratio of CR and PR in all subjects

    Measured: Estimated 24 months

  2. Disease Control Rate (DCR)

    Ratio of CR ,PR and SD in all subjects

    Measured: Estimated 24 months

  3. Overall survival (OS)

    From enrollment to death (for any reason)

    Measured: Estimated 36 months

  4. Security (CTCAE 5.0)

    Adverse events are described in terms of CTCAE 5.0

    Measured: From informed consent through 28 days following treatment completion

Timeline

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

  1. First posted26 May 2021
  2. Study start1 Jan 2021
  3. Primary completion1 Feb 2022
  4. Study completion6 Feb 2022

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
Model description
Pyrotinib Maleate plus Vinorelbine
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04903652
Sponsor's protocol ID
BC-Pyrotinib-NVB
Status last verified
Jan 2022
First submitted
19 May 2021
Last updated
7 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib Maleate and Vinorelbine in people with HER2-positive Advanced Breast Cancer, run by Tianjin Medical University Cancer Institute and 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 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: finished, as of the sponsor's last update on 7 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Estimated 24 months). 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 NCT04903652.

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 7 Apr 2022.

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