Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 3NCT07797218
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
A Phase 3 study testing Docetaxel, Pyrotinib and Trastuzumab (Herceptin) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab +… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Docetaxel, Pyrotinib and Trastuzumab (Herceptin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2030
- Phase
- Phase 3
- 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
- Signed informed consent.
- Age: Female patients aged 18-70 years.
- Breast cancer meeting the following criteria:
- Histologically confirmed invasive breast cancer, with primary tumor diameter ≥ 2.0 cm, Stage II-III as assessed by local standard methods.
- HER2-positive breast cancer, defined as Immunohistochemistry (IHC) score 3+ or In Situ Hybridization (ISH) showing HER2 gene amplification.
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
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- All required baseline laboratory tests and imaging studies completed before randomization.
- Adequate organ function
- For non-menopausal (amenorrhea < 12 months) or non-surgically sterile female patients (without ovaries and/or uterus): Agreement to abstain or use reliable and effective contraception during treatment and for at least 6 months after the last dose of study treatment.
- Investigator judgment that the patient can comply with the study protocol.
Who cannot join
- Bilateral breast cancer or metastatic (Stage IV) breast cancer.
- Significant cardiac disease:
- History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the past 6 months.
- New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) or history of NYHA Class III or IV CHF.
- High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate > 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or higher-grade atrioventricular (AV) block.
- Angina requiring anti-anginal medication.
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- Clinically significant valvular heart disease.
- ECG evidence of transmural myocardial infarction.
- Other malignancies within the past 5 years, except cured carcinoma in situ of the cervix or non-melanoma skin cancer.
- Severe systemic infection or patients with other serious diseases.
- Major non-breast surgery within 4 weeks of randomization, or patients who have not fully recovered from such surgery.
- Known history of Human Immunodeficiency Virus (HIV) infection.
- Active hepatitis B or hepatitis C virus infection.
- Known allergy or intolerance to the study drugs or their excipients.
- Prior cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason.
- Currently enrolled in or previously participated in a study of an investigational drug and received investigational treatment or used an investigational device within 4 weeks before the first dose of study treatment (12 months for investigational drugs/devices with anti-cancer or anti-proliferative properties).
- Vaccination with a live vaccine within 30 days before the first dose of the investigational drug.
- Psychiatric illness or substance abuse history that could affect compliance with trial requirements.
- Pregnancy or breastfeeding, or female patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.
- Patients judged by the investigator to be unsuitable for participation in this study.
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
Haoyu Wang, 86-021-64370045-602219, meredithwhy@163.com
About this study
Official title: Neoadjuvant Pyrotinib, Trastuzumab, Docetaxel Followed by Pertuzumab, Trastuzumab, Docetaxel Versus Pertuzumab, Trastuzumab, Docetaxel for the Treatment of Early or Locally Advanced HER2-Positive Breast Cancer: A Randomized, Multicenter, Open-Label Study
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
- Being tested
- Docetaxel, Pyrotinib, Trastuzumab (Herceptin), Pertuzumab
- Keywords
- breast cancer, HER2-positive, Neoadjuvant, Pyrotinib, 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.
DocetaxelDrug
docetaxel ivgtt q3w, 80-100mg/m2
PyrotinibDrug
pyrotinib 320mg p.o. qd
Trastuzumab (Herceptin)Drug
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w
PertuzumabDrug
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
| Study group | Role | What they receive |
|---|---|---|
| TPyP | Experimental | 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel Receives: Drug: Docetaxel; Drug: Pyrotinib; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab |
| TP | Active comparator | 4 cycles of Pertuzumab + Trastuzumab + Docetaxel Receives: Drug: Docetaxel; Drug: Trastuzumab (Herceptin); Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained of breast and lymph node samples
Measured: From enrollment to the end of treatment at 24 weeks
Secondary outcomes (7)
bpCR
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Measured: From enrollment to the end of treatment at 24 weeks
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: through study completion, an average of 2 year
OS
Time interval from randomization to death from any cause.
Measured: through study completion, an average of 5 year
Early ctDNA clearance
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Measured: From enrollment to the end of treatment at 24 weeks
Late ctDNA clearance
The rate of ctDNA clearance after first four cycles of neoadjuvant treatments
Measured: From enrollment to the end of treatment at 24 weeks
rCR
After completion of neoadjuvant therapy, no lesions presenting washout kinetic curve pattern in MRI
Measured: From enrollment to the end of treatment at 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: From enrollment to the end of treatment at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Jul 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT07797218
- Sponsor's protocol ID
- RJBC2602
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Pyrotinib, Trastuzumab, Docetaxel Followed by Pertuzumab, Trastuzumab, Docetaxel Versus Pertuzumab, Trastuzumab, Docetaxel for the Treatment of Early or Locally Advanced HER2-Positive Breast Cancer: A Randomized, Multicenter, Open-Label Study
- ClinicalTrials.gov ID
- NCT07797218
- Acronym / sponsor ID
- RJBC2602
- Keywords
- breast cancer, HER2-positive, Neoadjuvant, Pyrotinib, ctDNA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 1 Sep 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 is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPyP | Experimental | Drug: Docetaxel, Drug: Pyrotinib, Drug: Trastuzumab (Herceptin), Drug: Pertuzumab2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel |
| TP | Active comparator | Drug: Docetaxel, Drug: Trastuzumab (Herceptin), Drug: Pertuzumab4 cycles of Pertuzumab + Trastuzumab + Docetaxel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent.
- Age: Female patients aged 18-70 years.
- Breast cancer meeting the following criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1.
- All required baseline laboratory tests and imaging studies completed before randomization.
Key exclusion criteria (20 listed)
- Bilateral breast cancer or metastatic (Stage IV) breast cancer.
- Significant cardiac disease:
- Other malignancies within the past 5 years, except cured carcinoma in situ of the cervix or non-melanoma skin cancer.
- Severe systemic infection or patients with other serious diseases.
- Major non-breast surgery within 4 weeks of randomization, or patients who have not fully recovered from such surgery.
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 |
|---|---|---|
| Docetaxeldocetaxel ivgtt q3w, 80-100mg/m2 | Drug | TP, TPyP |
| Pyrotinibpyrotinib 320mg p.o. qd | Drug | TPyP |
| Trastuzumab (Herceptin)trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w | Drug | TP, TPyP |
| Pertuzumabpertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance | Drug | TP, TPyP |
Primary outcome
tpCR
Time frame: From enrollment to the end of treatment at 24 weeks
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained of breast and lymph node samples
7 secondary outcomes
bpCR
Time frame: From enrollment to the end of treatment at 24 weeks
EFS
Time frame: through study completion, an average of 2 year
OS
Time frame: through study completion, an average of 5 year
Early ctDNA clearance
Time frame: From enrollment to the end of treatment at 24 weeks
Late ctDNA clearance
Time frame: From enrollment to the end of treatment at 24 weeks
rCR
Time frame: From enrollment to the end of treatment at 24 weeks
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: From enrollment to the end of treatment at 24 weeks
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 1 Sep 2026.
- 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.
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 Docetaxel, Pyrotinib and Trastuzumab (Herceptin) in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), 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 10 inclusion and 20 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 1 Sep 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 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?
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 (86-021-64370045-602219, meredithwhy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR (time frame: From enrollment to the end of treatment at 24 weeks). 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 1 Sep 2026.