A Phase 3 interventional study of Docetaxel and Pyrotinib in Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment
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Among 101 studies testing pyrotinib in Breast Neoplasms — 49 open to participants now, 57 under way, 13 of them phase 3. pyrotinib · Breast Neoplasms.
Among the 101 studies testing pyrotinib in Breast Neoplasms, this one is the 30th largest by planned enrollment, is one of 8 that started in 2026, is one of 17 in phase 3, reaches primary completion later than 42 of the 56 other live ones, and was the 99th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →49 of the 101 studies testing pyrotinib in Breast Neoplasms are open now, in 1 country. Recruiting first, the newest first:
Peking University People's Hospital · Sites in China
Ages 18+
Fudan University · Sites in China
Ages 18–75 · Women only
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70 · Women only
Second Affiliated Hospital, School of Medicine, Zhejiang University · Sites in China
Ages 18–75 · Women only
Wenjin Yin · Sites in China
Ages 18+
By country, each count listing its studies:
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
101 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 70 · Phase 3 19 · Phase 4 2
First in 2013; this study’s year is marked. 8 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 220 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 100 across the 101 interventional studies. Of the 9 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 101 have an industry lead sponsor. The 10 most frequent:
Shanghai Jiao Tong University School of Medicine is the lead sponsor of 374 studies on the registry; 110 are open to participants now.
21 studies in Breast Neoplasms by Shanghai Jiao Tong University School of Medicine: 10 open now, 13 under way, 2 of them phase 3. Of 8 finished, 0 (0%) have results posted.
Among the 21 studies in Breast Neoplasms by Shanghai Jiao Tong University School of Medicine, this one is the 5th largest by planned enrollment of the 18 interventional ones that give a count, is one of 3 that started in 2026, is one of 3 in phase 3, reaches primary completion later than 10 of the 12 other live ones, and was the 20th registered.
Shanghai Jiao Tong University School of Medicine’s Breast Neoplasms studies by the year they started, since 2007.
6 of the studies testing pyrotinib in Breast Neoplasms that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04290793Phase 3Hebei Medical University Fourth HospitalNeoadjuvant Chemotherapy With Pyrotinib, Epirubicin and Cyclophosphamide Followed by Taxanes and Trastuzumab for HER-2+ Breast Cancer | 2026-12-01 |
| NCT03980054Phase 3Jiangsu HengRui Medicine Co., Ltd.A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer | 2027-06 |
| NCT04973319Phase 3Shengjing HospitalTrastuzumab Combined With Pertuzumab for Adjuvant Treatment of Breast Cancer After Neoadjuvant Therapy | 2027-08-01 |
| NCT06035679Youzhi ZhuPyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer | 2026-11-30 |
| NCT07708194Tianjin Medical University Cancer Institute and HospitalEntinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure | 2027-02 |
Add all 6 to your calendar (.ics) → With an account.
Among the 101 studies testing pyrotinib in Breast Neoplasms, from their registry updates:
Among Shanghai Jiao Tong University School of Medicine’s 21 in Breast Neoplasms:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Breast cancer meeting the following criteria:
Exclusion Criteria:
Significant cardiac disease:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel
Drug: Docetaxel · Drug: Pyrotinib · Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab
4 cycles of Pertuzumab + Trastuzumab + Docetaxel
Drug: Docetaxel · Drug: Trastuzumab (Herceptin) · Drug: Pertuzumab
docetaxel ivgtt q3w, 80-100mg/m2
pyrotinib 320mg p.o. qd
trastuzumab ivgtt q3w, 8mg/kg for initiation, 6mg/kg for maintenance, or 600mg sc q3w
pertuzumab ivgtt q3w, 840mg for initiation, 420mg for maintenance
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
Time frame: From enrollment to the end of treatment at 24 weeks
bpCR
After completion of neoadjuvant therapy and surgery, no residual invasive carcinoma in the evaluation of hematoxylin and eosin stained breast samples
Time frame: 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
Time frame: through study completion, an average of 2 year
OS
Time interval from randomization to death from any cause.
Time frame: through study completion, an average of 5 year
Early ctDNA clearance
The rate of ctDNA clearance after first two cycles of neoadjuvant treatments
Time frame: 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
Time frame: 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
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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jun 2028, 23 months after the start.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's planned 23 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Pyrotinib
Shanghai Jiao Tong University School of Medicine →