Metastatic Breast CancerPhase 2NCT03876587
Pyrotinib Combined With Docetaxel in the First-line Treatment of HER2-positive MBC
A Phase 2 study testing Pyrotinib Maleate combine with Docetaxel in people with Metastatic Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.
Trial summary
To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Pyrotinib Maleate combine with Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- Mar 2019to Dec 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
- do not chemotherapy for recurrent and metastatic lesions, but local treatment for local symptoms, such as radiotherapy for relieving bone pain, is allowed.
- if the patient is bilateral breast cancer, metastasis lesions must be HER2-positive.
- 18-70 years old.
- ECOG PS 0～1.
Show all 13Show fewer
- life expectancy is not less than 12 weeks.
- at least one measurable lesion according to RECIST 1.1.
- Endocrine therapy is allowed to relapse/metastasis disease; patients with previous adjuvant/neoadjuvant use of Taxus and trastuzumab, disease-free interval from the end of last adjuvant/neoadjuvant Taxus therapy to the progression of tumors (≥12 months), and disease-free interval from the end of last adjuvant/neoadjuvant trastuzumab to the progression of tumors (≥ 6 months).
- ANC ≥ 1.5×109/L,PLT ≥ 75×109/L,Hb ≥ 100 g/L;TBIL≤1.0ULN；ALT and AST≤3×ULN（ALT and AST≤5×ULN if liver metastasis）;BUN and Cr≤1.5×ULN and CCr≥50 mL/min.
- LVEF ≥ 50% and QTc≤480 ms.
- known hormone receptor status.
- Signed informed
Who cannot join
- Central nervous system metastasis.
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
- Participated in other drug clinical trials within 4 weeks before admission
- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
Show all 15Show fewer
- Receive other antitumour treatment at the same time
- A history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
- Has suffered from any heart disease
- Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
- According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- The patient did not recover from the toxicity of previous treatment to grade 0-1 (except hair loss).
- History of neurological or psychiatric disorders
- Along with CYP3A4 inhibitors or inducers or drugs that are using to prolong the QT interval
- Researchers believe that patients are not suitable for any other situation in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With Docetaxel in the First-line Treatment of HER2-positive Metastatic Breast Cancer
To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer.
Read the detailed description
A multi-center, one-arm, open label design study,which is planned to enroll 79 patients with HER2-positive metastatic breast cancer receiving first-line treatment with pyrotinib and docetaxel. The main purpose of this study was to observe the efficacy and safety of first-line treatment with pyrrolidine and docetaxel for HER2-positive metastatic breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Pyrotinib Maleate combine with Docetaxel
- Keywords
- Metastatic Breast Cancer, Pyrotinib Maleate, HER2 Targeted Therapy
- 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 Maleate combine with DocetaxelDrug
Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib Maleate combine with Docetaxel | Experimental | Pyrotinib Maleate combine with Docetaxel should be administrate to all subjects.
Initial dose: Pyrotinib Maleate 400mg oral administration everyday plus Docetaxel 75mg per square of BSA every three weeks intravenous injection. Receives: Drug: Pyrotinib Maleate combine with Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Ratio of CR and PR in all subjects
Measured: from enrollment to progression or death (for any reason), assessed up to 100 months
Secondary outcomes (4)
PFS
Progression-Free Survival
Measured: from enrollment to progression or death (for any reason),assessed up to 100 months
DoR
Duration of Response
Measured: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months
Clinical Benefit Rate
Ratio of CR,PR and SD greater than or equal to 24 weeks in all subjects
Measured: from enrollment to progression or death (for any reason),assessed up to 100 months
OS
Overall Survival
Measured: from enrollment to death (for any reason).assessed up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study startMar 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Zhejiang Cancer HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pyrotinib Maleate combine with Docetaxel
- Masking
- None (open label)
- Enrolment
- 79 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Xiaojia Wang(xj wang), Zhejiang Cancer Hospital
- Investigators
- Jian Huang, chief doctor, Study director, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876587
- Sponsor's protocol ID
- HR-BLTN-001
- Status last verified
- Mar 2019
- First submitted
- 11 Mar 2019
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the data will be shared from the trial begin and for 10 years.
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 39024777Zheng Y, Cao WM, Shao X, Shi Y, Cai L, Chen W, Liu J, Shen P, Chen Y, Wang X, Li H, Li M, Chen Z, Wang X. Pyrotinib plus docetaxel as first-line treatment for HER2-positive metastatic breast cancer: the PANDORA phase II trial. Nat Commun. 2023 Dec 14;14(1):8314. doi: 10.1038/s41467-023-44140-y.
PubMed 38097605
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With Docetaxel in the First-line Treatment of HER2-positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT03876587
- Acronym / sponsor ID
- HR-BLTN-001
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic Breast Cancer, Pyrotinib Maleate, HER2 Targeted Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 79 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- Mar 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Mar 2019 (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.
To explore the efficacy and safety of pyrotinib combined with docetaxel regimen in the first-line treatment of HER2-positive metastatic breast cancer.
Detailed description
A multi-center, one-arm, open label design study,which is planned to enroll 79 patients with HER2-positive metastatic breast cancer receiving first-line treatment with pyrotinib and docetaxel. The main purpose of this study was to observe the efficacy and safety of first-line treatment with pyrrolidine and docetaxel for HER2-positive metastatic breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pyrotinib Maleate combine with Docetaxel
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib Maleate combine with Docetaxel | Experimental | Drug: Pyrotinib Maleate combine with DocetaxelPyrotinib Maleate combine with Docetaxel should be administrate to all subjects. Initial dose: Pyrotinib Maleate 400mg oral administration everyday plus Docetaxel 75mg per square of BSA every three weeks intravenous injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
- do not chemotherapy for recurrent and metastatic lesions, but local treatment for local symptoms, such as radiotherapy for relieving bone pain, is allowed.
- if the patient is bilateral breast cancer, metastasis lesions must be HER2-positive.
- 18-70 years old.
Key exclusion criteria (15 listed)
- Central nervous system metastasis.
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
- Participated in other drug clinical trials within 4 weeks before admission
- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
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 |
|---|---|---|
| Pyrotinib Maleate combine with DocetaxelPyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer | Drug | Pyrotinib Maleate combine with Docetaxel |
Primary outcome
Objective Response Rate
Time frame: from enrollment to progression or death (for any reason), assessed up to 100 months
Ratio of CR and PR in all subjects
4 secondary outcomes
PFS
Time frame: from enrollment to progression or death (for any reason),assessed up to 100 months
DoR
Time frame: The first evaluation of CR or PR to progression or death (for any reason),assessed up to 100 months
Clinical Benefit Rate
Time frame: from enrollment to progression or death (for any reason),assessed up to 100 months
OS
Time frame: from enrollment to death (for any reason).assessed up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
- 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.
- Derived from this study: PubMed 38097605Zheng Y, Cao WM, Shao X, Shi Y, Cai L, Chen W, Liu J, Shen P, Chen Y, Wang X, Li H, Li M, Chen Z, Wang X. Pyrotinib plus docetaxel as first-line treatment for HER2-positive metastatic breast cancer: the PANDORA phase II trial. Nat Commun. 2023 Dec 14;14(1):8314. doi: 10.1038/s41467-023-44140-y.
- Individual participant dataSharing planned: Yes. the data will be shared from the trial begin and for 10 years.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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.
Jian Huang, chief doctor study director
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pyrotinib Maleate combine with Docetaxel in people with Metastatic Breast Cancer, run by Zhejiang 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 13 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 15 Mar 2019. 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 Xiaojia Wang, PhD (86 13906500190, wxiaojia0803@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: from enrollment to progression or death (for any reason), assessed up to 100 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 NCT03876587, 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 15 Mar 2019.