Metastatic Breast CancerPhase 3NCT03863223
A Study of Pyrotinib in Combination With Trastuzumab and Docetaxel in Patients With HER2 Metastatic Breast Cancer
A Phase 3 study testing Pyrotinib, Trastuzumab, Docetaxel in people with Metastatic Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for… 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?
- Pyrotinib, Trastuzumab, Docetaxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2019to 30 Jul 2024
- Phase
- Phase 3
- 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.
- Patients with measurable disease are eligible.
- 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
- History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
- History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab 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
Cancer Institute and Hospital,Chinese Academy of Medical Science
Beijing, Beijing Municipality
About this study
Official title: A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Pyrotinib, Trastuzumab, Docetaxel, Placebo, Trastuzumab, Docetaxel
- 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, Trastuzumab, DocetaxelDrug
Pyrotinib 400mg orally daily until progressive disease
Placebo, Trastuzumab, DocetaxelDrug
Placebo 400mg orally daily until progressive disease
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Pyrotinib Plus trastuzumab and docetaxel Receives: Drug: Pyrotinib, Trastuzumab, Docetaxel |
| B | Placebo comparator | Placebo plus trastuzumab and docetaxel Receives: Drug: Placebo, Trastuzumab, Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression Free Survival
Measured: Approximately 42 months
Secondary outcomes (5)
AEs+SAEs
Adverse Events and Serious Adverse Events
Measured: From the first drug administration to within 28 days for the last treatment
OS
Overall Survival
Measured: Up to 2 years
ORR
Objective Response Rate
Measured: Approximately 42 months
DoR
Duration of Objective Response
Measured: Approximately 42 months
CBR
Clinical Benefit rate
Measured: From the start of randomization to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start22 Apr 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Jul 2024 (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 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 590 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
- NCT03863223
- Sponsor's protocol ID
- HR-BLTN-III-MBC-C
- Status last verified
- Nov 2022
- First submitted
- 1 Mar 2019
- Last updated
- 23 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Zhou S, Li P, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Yao G, Fan Y, Lin J, Zhu X, Xu B. Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. BMJ. 2026 Mar 16;392:e087259. doi: 10.1136/bmj-2025-087259.
PubMed 41839514Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Liu H, Cheng Y, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Ye C, Dong F, Wu S, Zhu X, Xu B; PHILA Investigators. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ. 2023 Oct 31;383:e076065. doi: 10.1136/bmj-2023-076065.
PubMed 37907210
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3,Randomized, Double-blinded, Placebo-controlled Study to Evaluate Efficacy and Safety of Pyrotinib Plus Trastuzumab and Docetaxel Versus Placebo Plus Trastuzumab and Docetaxel in Patients With HER2 Positive MBC.
- ClinicalTrials.gov ID
- NCT03863223
- Acronym / sponsor ID
- HR-BLTN-III-MBC-C
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 5 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.
This is a randomized, double-blinded, multicenter phase 3 clinical trial to evaluate the efficacy and safety of pyrotinib plus trastuzumab plus docetaxel versus placebo plus trastuzumab plus docetaxel in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Pyrotinib, Trastuzumab, DocetaxelPyrotinib Plus trastuzumab and docetaxel |
| B | Placebo comparator | Drug: Placebo, Trastuzumab, DocetaxelPlacebo plus trastuzumab and docetaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HER2 positive recurrent or metastasis breast cancer.
- Patients with measurable disease are eligible.
- 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)
- History of anti-cancer therapy for MBC（with the exception of one prior hormonal regimen for MBC）.
- History of HER tyrosine kinase inhibitors or monoclonal antibody for breast cancer in any treatment setting，except trastuzumab 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 |
|---|---|---|
| Pyrotinib, Trastuzumab, DocetaxelPyrotinib 400mg orally daily until progressive disease | Drug | A |
| Placebo, Trastuzumab, DocetaxelPlacebo 400mg orally daily until progressive disease | Drug | B |
Primary outcome
PFS
Time frame: Approximately 42 months
Progression Free Survival
5 secondary outcomes
AEs+SAEs
Time frame: From the first drug administration to within 28 days for the last treatment
OS
Time frame: Up to 2 years
ORR
Time frame: Approximately 42 months
DoR
Time frame: Approximately 42 months
CBR
Time frame: From the start of randomization to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2022.
- Derived from this study: PubMed 41839514Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Zhou S, Li P, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Yao G, Fan Y, Lin J, Zhu X, Xu B. Pyrotinib or placebo in combination with trastuzumab and docetaxel for HER2 positive metastatic breast cancer: long term survival results from randomised phase 3 PHILA trial. BMJ. 2026 Mar 16;392:e087259. doi: 10.1136/bmj-2025-087259.
- Derived from this study: PubMed 37907210Ma F, Yan M, Li W, Ouyang Q, Tong Z, Teng Y, Wang Y, Wang S, Geng C, Luo T, Zhong J, Zhang Q, Liu Q, Zeng X, Sun T, Mo Q, Liu H, Cheng Y, Cheng J, Wang X, Nie J, Yang J, Wu X, Wang X, Li H, Ye C, Dong F, Wu S, Zhu X, Xu B; PHILA Investigators. Pyrotinib versus placebo in combination with trastuzumab and docetaxel as first line treatment in patients with HER2 positive metastatic breast cancer (PHILA): randomised, double blind, multicentre, phase 3 trial. BMJ. 2023 Oct 31;383:e076065. doi: 10.1136/bmj-2023-076065.
- Individual participant dataSharing planned: No
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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 3 study testing Pyrotinib, Trastuzumab, Docetaxel 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 5 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: status not confirmed, as of the sponsor's last update on 23 Nov 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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?
PFS (time frame: Approximately 42 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 NCT03863223, 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 23 Nov 2022.