Breast CancerPhase 2NCT07335081
ctDNA in HER2+ EBC Neoadjuvant Treatment
A Phase 2 study testing pyrotinib, pertuzumab and trastuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course… 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, pertuzumab and trastuzumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2024to 31 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
- histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter >2cm)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
- No prior treatment
Who cannot join
- Bilateral or metastatic breast cancer
- History of other malignancies
- Severe cardiovascular disease
- Allergic to any of the regimens
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, 200025
Haoyu Wang, 86 18817865256, meredithwhy@163.com
About this study
Official title: A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
- Conditions
- Breast Cancer
- Being tested
- pyrotinib, pertuzumab, trastuzumab, docetaxel
- Keywords
- Breast cancer, Neoadjuvant therapy, HER2 positive, ctDNA
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinibDrug
pyrotinib 320mg p.o. qd
pertuzumabDrug
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
trastuzumabDrug
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance
docetaxelDrug
docetaxel ivgtt q3w, 80-100mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Pyrotinib-initiated arm | Experimental | two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab Receives: Drug: pyrotinib; Drug: pertuzumab; Drug: trastuzumab; Drug: docetaxel |
| Pertuzumab-initiated arm | Active comparator | four cycles of docetaxel + trastuzumab + pertuzumab Receives: Drug: pertuzumab; Drug: trastuzumab; Drug: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
ctDNA clearance after one cycle neoadjuvant treatment
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
Measured: 3 months after neoadjuvant treatment initation
Secondary outcomes (7)
ctDNA clearance after two cycle neoadjuvant treatment
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Measured: 3 months after neoadjuvant treatment initation
pCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained mamtectomy samples and all ipsilateral lymph node samples
Measured: 6 months after neoadjuvant treatment initation
bpCR rate
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Measured: 6 months after neoadjuvant treatment initation
ORR
The proportion of patients whose tumor volume shrinks to a prespecified value and is able to maintain the minimum time limit, defined as the sum of the proportion of complete response (CR) and partial response (PR, with a reduction in tumor length and diameter greater than 30%).
Measured: 6 months after neoadjuvant treatment initation
EFS
The time interval from randomization to the first recording of the following events: disease progression (before surgery), as determined by investigator reference RECIST1.1, combined with clinical evaluation, final judgment; postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause
Measured: 2 years after surgery
DFS
The time interval from the first date of disease-free (i.e., the date of surgery) to the first recording of the following events; Postoperative disease recurrence (local, regional, distal, or contralateral); second primary malignancy; Death from any cause.
Measured: 2 years after surgery
OS
Time interval from randomization to death from any cause.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Feb 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunwei Shen, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335081
- Sponsor's protocol ID
- RJBC2401
- Status last verified
- Mar 2026
- First submitted
- 21 Dec 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07335081
- Acronym / sponsor ID
- RJBC2401
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Neoadjuvant therapy, HER2 positive, ctDNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jan 2026 (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 study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pyrotinib-initiated arm | Experimental | Drug: pyrotinib, Drug: pertuzumab, Drug: trastuzumab, Drug: docetaxeltwo cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab |
| Pertuzumab-initiated arm | Active comparator | Drug: pertuzumab, Drug: trastuzumab, Drug: docetaxelfour cycles of docetaxel + trastuzumab + pertuzumab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter >2cm)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography
- No prior treatment
Key exclusion criteria (4 listed)
- Bilateral or metastatic breast cancer
- History of other malignancies
- Severe cardiovascular disease
- Allergic to any of the regimens
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 320mg p.o. qd | Drug | Pyrotinib-initiated arm |
| pertuzumabpertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance | Drug | Pertuzumab-initiated arm, Pyrotinib-initiated arm |
| trastuzumabtrastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance | Drug | Pertuzumab-initiated arm, Pyrotinib-initiated arm |
| docetaxeldocetaxel ivgtt q3w, 80-100mg/m2 | Drug | Pertuzumab-initiated arm, Pyrotinib-initiated arm |
Primary outcome
ctDNA clearance after one cycle neoadjuvant treatment
Time frame: 3 months after neoadjuvant treatment initation
The rate of ctDNA clearance after first cycle of neoadjuvant treatment
7 secondary outcomes
ctDNA clearance after two cycle neoadjuvant treatment
Time frame: 3 months after neoadjuvant treatment initation
pCR rate
Time frame: 6 months after neoadjuvant treatment initation
bpCR rate
Time frame: 6 months after neoadjuvant treatment initation
ORR
Time frame: 6 months after neoadjuvant treatment initation
EFS
Time frame: 2 years after surgery
DFS
Time frame: 2 years after surgery
OS
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
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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.
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, pertuzumab and trastuzumab in people with Breast Cancer, run by Shanghai Jiao Tong University School of Medicine 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 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: looking for participants now, as of the sponsor's last update on 24 Mar 2026. 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 Haoyu Wang (86 18817865256, meredithwhy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ctDNA clearance after one cycle neoadjuvant treatment (time frame: 3 months after neoadjuvant treatment initation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2026.