Metastatic Breast CancerPhase 1NCT04367090
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
A Phase 1 study testing Docetaxel, trastuzumab and Pyrotinib in people with Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Docetaxel, trastuzumab and Pyrotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteChina
- Study dates
- 28 May 2020to 24 May 2023
- Phase
- Phase 1
- 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
- HER2 positive recurrent or metastasis breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function.
- Signed, written inform consent obtained prior to any study procedure.
Who cannot join
- Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
- History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
- Assessed by the investigator to be unable receive systemic chemotherapy.
- History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
About this study
Official title: An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Docetaxel, trastuzumab, 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.
Docetaxel, trastuzumabDrug
Docetaxel and trastuzumab once per cycle
PyrotinibDrug
Pyrotinib 400/320 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib and docetaxel plus trastuzumab | Experimental | Not described Receives: Drug: Docetaxel, trastuzumab; Drug: Pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
Peak Plasma Concentration (Cmax) of pyrotinib
Measured: Approximately 2 months
Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel
Measured: Approximately 2 months
Secondary outcomes (4)
ORR
Objective Response Rate
Measured: Approximately 17 months
AEs+SAEs
Adverse Events and Serious Adverse Events
Measured: Approximately 17 months
λz
Measured: Approximately 6 months
The incidence of≥3 grade diarrhea with different treatment
Measured: Approximately 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start28 May 2020
- Primary completion10 Aug 2022
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367090
- Sponsor's protocol ID
- BLTN-Ig
- Status last verified
- Sep 2023
- First submitted
- 24 Apr 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm and Multi-center Pharmacokinetic Study of Pyrotinib and Docetaxel Plus Trastuzumab in Patients With HER2 Positive Recurrent or Metastasis Breast Cancer.
- ClinicalTrials.gov ID
- NCT04367090
- Acronym / sponsor ID
- BLTN-Ig
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 May 2020 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
The secondary objective of the study is to evaluate the safety and efficacy (ORR) of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib and docetaxel plus trastuzumab | Experimental | Drug: Docetaxel, trastuzumab, Drug: Pyrotinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HER2 positive recurrent or metastasis breast cancer.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Adequate organ function.
- Signed, written inform consent obtained prior to any study procedure.
Key exclusion criteria (5 listed)
- Patients received more than 1 line of chemotherapy or immunotherapy in the phase of recurrence / metastasis.
- History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab ,or Pertuzumab used in the neo-adjuvant or adjuvant setting.
- Assessed by the investigator to be unable receive systemic chemotherapy.
- History of other malignancy within the last 5 years，except for carcinoma in situ of cervix，basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent.
- Pregnant or lactating women，or for women of childbearing potential unwilling to use a highly-effective contraception during of the study treatment and for at least 7 months after the last dose of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel, trastuzumabDocetaxel and trastuzumab once per cycle | Drug | Pyrotinib and docetaxel plus trastuzumab |
| PyrotinibPyrotinib 400/320 mg orally daily | Drug | Pyrotinib and docetaxel plus trastuzumab |
Primary outcome
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel
Time frame: Approximately 2 months
Peak Plasma Concentration (Cmax) of pyrotinib
Pharmacokinetic parameter: AUC of pyrotinib and docetaxel
Time frame: Approximately 2 months
Area under the plasma concentration versus time curve (AUC) of pyrotinib and docetaxel
4 secondary outcomes
ORR
Time frame: Approximately 17 months
AEs+SAEs
Time frame: Approximately 17 months
λz
Time frame: Approximately 6 months
The incidence of≥3 grade diarrhea with different treatment
Time frame: Approximately 17 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Derived from this study: PubMed 39024777Dai 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Docetaxel, trastuzumab and Pyrotinib in people with Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 4 inclusion and 5 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 18 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 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.
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?
Pharmacokinetic parameter: Cmax of pyrotinib and docetaxel (time frame: Approximately 2 months). 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 NCT04367090, 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 18 Sep 2023.