HER2-positive Breast CancerPhase 3NCT03588091
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
A Phase 3 study testing Pyrotinib, Trastuzumab and Docetaxel in people with HER2-positive Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 17 sites in China.
Trial summary
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally 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 Breast Cancer
- What is being tested?
- Pyrotinib, Trastuzumab and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- 17 sitesChina
- Study dates
- 24 Jul 2018to 31 Jan 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
- female patients, 18 years ≤ age ≤ 75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Known hormone receptor status.
- Cardiovascular:Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
Who cannot join
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
The Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, 100071
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Sun Yet-Sen University Cancer Center
Guangzhou, Guangdong, 510010
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510289
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Huai'an First People's Hospital
Huaian, Jiangsu, 223001
Shandong Cancer Hospital
Jinan, Shandong, 250000
JiangSu Province Hospital
Nanjing, Jiangsu, 210029
The Affiliated Hospital Of Qingdao University
Qingdao, Shandong, 266100
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xian, Shanxi, 710004
The affiliated cancer hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, 450000
About this study
Official title: A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Pyrotinib, Placebo Oral Tablet, Trastuzumab, Docetaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PyrotinibDrug
pyrotinib: 400mg orally daily;
Placebo Oral TabletDrug
placebo: 400mg orally daily;
TrastuzumabDrug
trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
DocetaxelDrug
docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| arm1 | Experimental | Pyrotinib Plus trastuzumab and docetaxel Receives: Drug: Pyrotinib; Drug: Trastuzumab; Drug: Docetaxel |
| arm2 | Placebo comparator | placebo plus trastuzumab and docetaxel Receives: Drug: Placebo Oral Tablet; Drug: Trastuzumab; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites
Measured: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days)
Event-free survival(EFS)
Measured: Following surgery until Year 3
Disease-free Survival (DFS)
Measured: Following surgery until Year 3
Distance Disease-free Survival (DDFS)
Measured: Following surgery until Year 3
Objective Response Rate (ORR) during neoadjuvant period
Measured: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start24 Jul 2018
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
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 HER2-positive 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
- 355 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
- NCT03588091
- Sponsor's protocol ID
- HR-BLTN-III-NeoBC
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2018
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3.
PubMed 36575513
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Muticenter Double-blind Phase III Study of Neoadjuvant Pyrotinib Plus Trastuzumab and Docetaxel Compared With Placebo Plus Trastuzumab and Docetaxel in Women With HER2 Positive Early Stage or Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03588091
- Acronym / sponsor ID
- HR-BLTN-III-NeoBC
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 17 Jul 2018 (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 randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant treatment in HER2 positive early stage or locally advanced breast cancer.
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 |
|---|---|---|
| arm1 | Experimental | Drug: Pyrotinib, Drug: Trastuzumab, Drug: DocetaxelPyrotinib Plus trastuzumab and docetaxel |
| arm2 | Placebo comparator | Drug: Placebo Oral Tablet, Drug: Trastuzumab, Drug: 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 (7 listed)
- female patients, 18 years ≤ age ≤ 75 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）:Primary tumour greater than 2 cm diameter
- HER2 positive (HER2+++ by IHC or FISH+)
- Known hormone receptor status.
Key exclusion criteria (4 listed)
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow tablets.
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 |
|---|---|---|
| Pyrotinibpyrotinib: 400mg orally daily; | Drug | arm1 |
| Placebo Oral Tabletplacebo: 400mg orally daily; | Drug | arm2 |
| Trastuzumabtrastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles; | Drug | arm1, arm2 |
| Docetaxeldocetaxel:after the biological window, 100mg/m2 for a total of 4 cycles | Drug | arm1, arm2 |
Primary outcome
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC)
Time frame: through study completion, an average of 1 year
5 secondary outcomes
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by sites
Time frame: Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4,each cycle is 21 days)
Event-free survival(EFS)
Time frame: Following surgery until Year 3
Disease-free Survival (DFS)
Time frame: Following surgery until Year 3
Distance Disease-free Survival (DDFS)
Time frame: Following surgery until Year 3
Objective Response Rate (ORR) during neoadjuvant period
Time frame: Baseline up to cycle 4 (assessed at Baseline, at the time of pre-surgery)up to approximately 12 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 22 Aug 2025.
- Derived from this study: PubMed 36575513Wu J, Jiang Z, Liu Z, Yang B, Yang H, Tang J, Wang K, Liu Y, Wang H, Fu P, Zhang S, Liu Q, Wang S, Huang J, Wang C, Wang S, Wang Y, Zhen L, Zhu X, Wu F, Lin X, Zou J. Neoadjuvant pyrotinib, trastuzumab, and docetaxel for HER2-positive breast cancer (PHEDRA): a double-blind, randomized phase 3 trial. BMC Med. 2022 Dec 27;20(1):498. doi: 10.1186/s12916-022-02708-3.
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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.
17 sites 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 and Docetaxel in people with HER2-positive Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 17 sites 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 7 inclusion and 4 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
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?
Percentage of Participants With Pathological Complete Response (pCR) at the Time of Surgery evaluated by independent review committee(IRC) (time frame: through study completion, an average of 1 year). 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 NCT03588091, 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 22 Aug 2025.