A Phase 2 interventional study of Trastuzumab and Docetaxel in Breast Cancer, sponsored by Ruijin Hospital. Terminated at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 373 studies testing trastuzumab in Breast Neoplasms — 56 open to participants now, 85 under way, 5 of them phase 3. Trastuzumab · Breast Neoplasms.
Among the 373 studies testing trastuzumab in Breast Neoplasms, this one is the 150th largest by enrollment of the 365 interventional ones that give a count, is one of 6 that started in 2017, is one of 239 in phase 2, and was the 258th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →56 of the 373 studies testing trastuzumab in Breast Neoplasms are open now, in 12 countries. Recruiting first, the newest first:
SWOG Cancer Research Network · Sites in United States
Ages 18+
Duke University · Sites in United States
Ages 18+ · Women only
Rutgers, The State University of New Jersey · Sites in United States
Ages 18–90
Shanghai Jiao Tong University School of Medicine · Sites in China
Ages 18–70 · Women only
Institut Curie · Sites in France
Ages 18+
By country, each count listing its studies:
Trastuzumab: first FDA approval 1998 (HERCEPTIN), first EMA approval 2000. What it is approved for, and 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 and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, trastuzumab is the treatment under test here. Read study by study →
373 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 50 · Phase 2 270 · Phase 3 61 · Phase 4 7
First in 1998; this study’s year is marked. 6 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 78 is close to the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 62 across the 365 interventional studies. Of the 235 that completed or were terminated, 128 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
73 of 373 have an industry lead sponsor. The 10 most frequent:
Ruijin Hospital is the lead sponsor of 679 studies on the registry; 387 are open to participants now.
21 studies in Breast Neoplasms by Ruijin Hospital: 10 open now, 14 under way, 1 of them phase 3. Of 3 finished, 0 (0%) have results posted.
Among the 21 studies in Breast Neoplasms by Ruijin Hospital, this one is the 11th largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2017, is one of 4 in phase 2, and was the 5th registered.
Ruijin Hospital’s Breast Neoplasms studies by the year they started, since 2015.
22 of the studies testing trastuzumab in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06035679Youzhi ZhuPyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer | 2026-11-30 |
| NCT05891561Shanghai Jiao Tong University School of MedicineShort-course Trastuzumab, Pertuzumab with Taxanes in the Adjuvant Treatment of Early HER2-positive Breast Cancer | 2026-12 |
| NCT04886531Ruth O'ReganTrial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in ER-Positive, HER-2 Positive Breast Cancers | 2026-12-22 |
| NCT07095023Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityNeoadjuvant Oral Paclitaxel Plus Subcutaneous Pertuzumab/Trastuzumab in Patients With HER2-positive Breast Cancer | 2026-12-30 |
| NCT07635342Hebei Medical University Fourth HospitalPyrotinib Plus Trastuzumab and Chemotherapy for HER2-Positive Early Breast Cancer | 2026-12-31 |
Add all 22 to your calendar (.ics) → With an account.
Among the 373 studies testing trastuzumab in Breast Neoplasms, from their registry updates:
Among Ruijin Hospital’s 21 in Breast Neoplasms:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
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.
Women aged ≥18 years
Have finished radical operation
confirmed dignosis of infiltrating primary breast cancer
According to AJCC ,pT≤1cm, pN0,no evidence for
Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
Has (ECOG) Performance Score 0-1,expected survival time > 12 months
Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of to avoid pregnancy during the study.
Written according to the local ethics committee requirements.
Exclusion Criteria:
pT>1cm or node positive
breast cancer
Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Patients with medical conditions that indicate intolerant to chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
Has symptomatic peripheral neuropathy > grade 2 according to NCI
Known severe allergy to any drugs in this study
Has cadiac Dysfunction or lung dysfunction defined as follows:
Has active or with abnormal liver function tests (LFTs) or is known to be positive
Patient is pregnant or breast feeding
-
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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 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.
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.
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.
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.
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.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
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.
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.
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.
12 weeks adjuvant docetaxel plus trastuzumab
Drug: Trastuzumab · Drug: Docetaxel
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.
Docetaxel 100mg/m2，d1，iv，q3w\*4
Disease-free Survival
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Time frame: 3-year estimates
Breast Cancer Specific Survival
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive.
Time frame: 3-year estimates
Overall Survival
Defined as the time from the date of surgery to death from any cause; or censored at date last known alive.
Time frame: 3-year estimats
Treatment-related adverse events
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0
Time frame: up to 4 months
Change of LVEF after treatment
The change of LVEF after 12 weeks treatment compared to the baseline LVEF
Time frame: up to 4 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2017 to primary completion in Jul 2024, 78 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drugs tested here: Trastuzumab · Docetaxel