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Breast CancerPhase 2NCT06254690

The Dosing Regimen of Pyrotinib in HER2-positive Advanced First-line Breast Cancer: a Phase II Clinical Study

A Phase 2 study testing Pyrotinib dose escalation and Pyrotinib dose normal in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pyrotinib dose escalation and Pyrotinib dose normal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteChina
Study dates
1 Jan 2024to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • The subjects voluntarily joins the study and signs the informed consent;
  • Subject is an adult female ≥ 18 years old and ≤ 70 years old at the time of informed consent.
  • HER2-positive advanced breast cancer confirmed by pathology (HER2-positive expression refers to those with at least one tumor cell immunohistochemical staining intensity of 3+ or 2+ positive by fluorescence in situ hybridization [FISH] in the pathological examination/review of the primary or metastatic lesion conducted by the pathology department of the Central Hospital)
  • Stage IV breast cancer according to American Joint Committee on Cancer(AJCC) staging system version 8.
  • Subjects did not receive systemic antitumor therapy at the stage of recurrence/metastasis;
  • At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors version 1.1 criteria
  • When randomized, Eastern Cooperative Oncology Group(ECGO) physical fitness status is 0 or 1 point.
  • Vital organ function meets the following requirements (excluding the use of any blood components and cell growth factors during screening) : Absolute neutrophil (ANC) count ≥1.5×109/L; Platelet (PLT) ≥100×109/L; Hemoglobin (HB) ≥9g/dL; Serum albumin ≥3g/dL; Thyroid stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be investigated at the same time, if T3 and T4 levels are normal, they can be included in the group); Bilirubin ≤1.5 ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN; Alkaline phosphatase (AKP) ≤ 2.5 times ULN; Serum creatinine (Cr) ≤1.5 times ULN or creatinine clearance ≥60mL/min.

Who cannot join

  • Any previous tyrosine kinase inhibitor therapy against HER2 target;
  • Patients with known active central nervous system metastases without surgery or radiation therapy, except those who have been stable for at least 1 month after treatment and have been off corticosteroids for >2 weeks;
  • Pial metastasis confirmed by MRI or lumbar puncture;
  • Inflammatory breast cancer or other malignancies within the previous 5 years, excluding cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • Any antitumor therapy within 4 weeks prior to enrollment;
  • Pregnant or breastfeeding women (women of childbearing age must have a negative pregnancy test within 14 days prior to the first dose, if positive, the pregnancy must be ruled out by ultrasound);
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  • Patients with gastrointestinal insufficiency or gastrointestinal disease significantly affecting the absorption of the investigational drug (e.g., uncontrolled ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or resection of the small intestine);
  • Patients with ascites, pleural effusion and pericardial effusion accompanied by clinical symptoms requiring drainage at baseline, or patients with serosal effusion drainage within 4 weeks before the first medication;
  • Patients with a history of immunodeficiency, including HIV testing positive, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Patients with a major surgical procedure or significant trauma within 4 weeks before starting treatment, or expected to undergo major surgery;
  • Concomitant medical conditions (e.g., severe hypertension, diabetes, thyroid disease, co-active hepatitis B/C, and other active infections, etc.) that are deemed by the investigator to seriously endanger the patient's safety or to interfere with the patient's completion of the study;
  • Inability to understand or follow research instructions and requirements;
  • The investigator considers the patient unsuitable for entry into this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yongmei Yin, Ph.D contact

025-68307102

ymyin@njmu.edu.cn

China1 site, 1 recruiting

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu

    Yongmei Yin

    Recruiting

Other trials in China

About this study

Official title: Safety and Efficacy of Pyrotinib in Transition From a Low-dose to Normal-dose Regimen in HER2-positive Advanced First-line Breast Cancer: a Multicenter, Open Phase II Clinical Study

Evaluate the safety and efficacy of Pyrotinib in the transition from low-dose to normal-dose regimen for HER2-positive advanced first-line breast cancer

Read the detailed description

This study is planned to include 102 patients with HER2-positive advanced breast cancer meeting the admission criteria between 2023-12-01 and 2024-11-01. Statistical software will be used by the randomization officers for 1:1 allocation to pyrotinib dose increasing trial group and normal pyrotinib dose control group .

The primary endpoint of this study was grade ≥3 treatment-emergent diarrhea incidence during the first 2 cycles according to Common Terminology Criteria for Adverse Events, version 5.0, and secondary endpoints were adverse effects of pyrotinib during the study, efficacy (progression-free survival and overall survival), and patient-reported outcome.

Conditions
Breast Cancer
Being tested
Pyrotinib dose escalation, Pyrotinib dose normal
Keywords
HER2 positive, Pyrotinib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Pyrotinib dose escalationDrug

    Also called Trastuzumab, Docetaxel

    Pyrotinib: 240mg in the first week, 320mg in the second week, and 400mg in the third week and thereafter, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)

  • Pyrotinib dose normalDrug

    Also called Trastuzumab, Docetaxel

    Pyrotinib: 400mg per week, by mouth(po),once a day(qd) Trastuzumab: 8mg/Kg in the first cycle, 6mg/Kg in the subsequent cycle, intravenous(iv), every 3 weeks(q3w) Docetaxel: 75mg/m2，intravenous(iv), every 3 weeks(q3w)

Study groups in NCT06254690
Study groupRoleWhat they receive
Pyrotinib dose escalation groupExperimentalPyrotinib: 240mg in the first week, 320mg in the second week, and 400mg in the third week and thereafter, by mouth(po),once a day(qd)
Receives: Drug: Pyrotinib dose escalation
Pyrotinib dose normal groupActive comparatorPyrotinib: 400mg per week, by mouth(po),once a day(qd)
Receives: Drug: Pyrotinib dose normal

What is being measured

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

  1. Incidence of 2 cycles ≥ grade 3 diarrhea

    Grade ≥3 treatment-emergent diarrhea incidence at the end of the first 2 cycles（each cycle is 28 days） according to Common Terminology Criteria for Adverse Events(CTCAE) v5.0.

    Measured: From the date of enrollment to 2 cycles（each cycle is 28 days） of the treatment

Secondary outcomes (4)

  1. Incidence of Treatment-Emergent Adverse Events

    Adverse events include abnormal liver function, myelosuppression and so on.

    Measured: through study completion, an average of 1 year(From the date of enrollment to 30 days after the last dose)

  2. Progression Free Survival

    Progression-free survival is defined as the time from the date of randomization to the date of the first documented progression as per local review and according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or death due to any cause.

    Measured: From date of randomization until the date of first documented progression from any cause, whichever came first, assessed up to 100 months

  3. Overall survival

    Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

    Measured: From date of randomization until the date of death from any cause, assessed up to 100 months

  4. Patient report outcome

    The rating is evaluated by Functional Assessment of Cancer Therapy-Breast scale. It contains questions in five dimensions, with scores ranging from 0 to 4 for each question, with higher scores generally indicating a better quality of life

    Measured: through study completion, an average of 1 year(From the date of enrollment to the clinical outcome from patients' report)

Timeline

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

  1. First posted12 Feb 2024
  2. Study start1 Jan 2024
  3. Primary completion1 Nov 2026 (estimated)
  4. Study completion1 Dec 2026 (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
Sequential
Masking
None (open label)
Enrolment
102 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06254690
Sponsor's protocol ID
Photine
Status last verified
Feb 2024
First submitted
28 Jan 2024
Last updated
12 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib dose escalation and Pyrotinib dose normal in people with Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical 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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Yongmei Yin, Ph.D (025-68307102, ymyin@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of 2 cycles ≥ grade 3 diarrhea (time frame: From the date of enrollment to 2 cycles（each cycle is 28 days） of the treatment). 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 NCT06254690.

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 12 Feb 2024.

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