An observational study in HER2-Positive Breast Cancer and Advanced Breast Cancer, sponsored by Xin Li. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Xin Li · Observational
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Among 1,928 studies in Breast Neoplasms with a site in China — 866 open to participants now, 1,064 under way, 210 of them phase 3. Breast Neoplasms · China.
Among the 1,928 studies in Breast Neoplasms with a site in China, this one is the 41st largest by enrollment of the 407 observational ones that give a count, is one of 128 that started in 2020, is one of 407 observational ones, and was the 1,905th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →866 of the 1,928 studies in Breast Neoplasms with a site in China are open now. Recruiting first, the newest first:
First Affiliated Hospital of Guangxi Medical University · Sites in China
Ages 18–70 · Women only
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
Fudan University · Sites in China
Ages 18–75 · Women only
Fudan University · Sites in China
Ages 18+ · Women only
Guangdong Provincial People's Hospital · Sites in China
Ages 18–75 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
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.
1,928 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 1 279 · Phase 2 641 · Phase 3 371 · Phase 4 51
First in 1997; this study’s year is marked. 128 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 2,250 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 120 across the 1,519 interventional studies, 240 across the 407 observational. Of the 444 that completed or were terminated, 77 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
488 of 1,928 have an industry lead sponsor. The 10 most frequent:
Xin Li is the lead sponsor of 2 studies on the registry; none are open to participants now.
Xin Li has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
250 of the studies in Breast Neoplasms with a site in China that are under way reach primary completion within a year, 42 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06954961Phase 3InventisBio Co., LtdA Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer | 2026-11-30 |
| NCT06968585Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy | 2026-11-30 |
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
| 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 |
Add all 250 to your calendar (.ics) → With an account.
Among the 1,928 studies in Breast Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This retrospective observational cohort study emulates a target trial to compare the effectiveness and safety of two first-line treatment strategies for women with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer in routine clinical practice: pertuzumab plus trastuzumab and docetaxel versus trastuzumab and docetaxel.
Data were obtained from electronic health records held by the National Health and Medical Big Data (Eastern) Center and linked with the Jiangsu Provincial Mortality Registry. Eligible patients initiated one of the two treatment strategies between January 1, 2020, and December 31, 2024. Time zero was defined as the date of the first administration of the qualifying first-line regimen. No minimum number of treatment cycles was required. The primary outcome was overall survival. Secondary outcomes included progression-free survival and prespecified adverse events.
Patients were classified according to the first-line regimen initiated on the index date. Time zero was defined as the date of first administration of pertuzumab plus trastuzumab and chemotherapy or trastuzumab and chemotherapy. Eligibility criteria were assessed using information available on or before time zero. Patients were not required to complete a minimum number of treatment cycles and were followed from treatment initiation regardless of subsequent treatment discontinuation or modification.
The study population comprised adult female patients with HER2-positive unresectable locally advanced, recurrent, or metastatic breast cancer who initiated first-line treatment with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel between January 1, 2020 and December 31, 2024. Eligible patients were retrospectively identified from the National Health and Medical Big Data (Eastern) Center. Electronic health record data were linked to the Jiangsu mortality registry. The index date (time zero) was defined as the date of the first administration of the index treatment regimen. Patients meeting the prespecified eligibility criteria during the study period were included.
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.
Initiation of treatment with either:
Exclusion Criteria:
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
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.
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.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pertuzumab · Drug: Trastuzumab · Drug: Docetaxel
Drug: Pertuzumab · Drug: Docetaxel
Pertuzumab administered as part of first-line dual HER2-targeted therapy with trastuzumab and docetaxel. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Trastuzumab administered as part of first-line HER2-targeted therapy with docetaxel, with or without pertuzumab. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Docetaxel administered as first-line chemotherapy in combination with HER2-targeted therapy. Exposure was identified from electronic prescriptions, medication orders, and administration records.
Overall Survival (OS)
Overall survival was defined as the time from the first administration of the index first-line treatment regimen to death from any cause.
Time frame: From the index date until death, last known follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Real-World Progression-Free Survival (rwPFS)
Real-world progression-free survival was defined as the time from the index date, defined as the first administration of the qualifying first-line treatment regimen, to the first documented real-world disease progression or death from any cause, whichever occurred first.
Time frame: From the index date until documented real-world disease progression, death, last known progression-free follow-up, or December 31, 2024, whichever occurred first (up to 60 months)
Proportion of Participants With Prespecified Grade 3 or Higher Adverse Events
Adverse-event severity was determined according to the severity grade documented in the electronic health record.
Time frame: From the index date through the documented end of first-line treatment (up to 60 months)
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2020 to primary completion in Dec 2024, 56 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xin Li