An observational study in Breast Neoplasms and HER2-negative Breast Cancer, sponsored by Peking Union Medical College Hospital. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Peking Union Medical College Hospital · Observational
This is an observational cohort study. Investigators do not assign any intervention to participants. Chemotherapy was received in a completed clinical trial or is determined by the treating physicians as part of routine care, and study results will not be used to guide treatment.
The study aims to identify clinicopathological and molecular features associated with outcomes after anthracycline-free or anthracycline-containing chemotherapy in women with high-risk, HER2-negative early breast cancer. Existing clinical and follow-up data and archived tumor tissue from participants of a trial completed at Peking Union Medical College Hospital (NCT01354522; enrollment ended in 2013) will be analyzed with gene expression, metabolic, and digital pathology methods to develop a prediction model. Tumor tissue remaining after routine surgery or biopsy will also be collected, with informed consent, from up to 50 additional patients for single-cell sequencing. All analyses are exploratory.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 100 is below the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,155 studies on the registry; 475 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Women with high-risk, HER2-negative early breast cancer treated at Peking Union Medical College Hospital, including participants of NCT01354522 and patients undergoing surgery or biopsy during the study period.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Patients who received or are scheduled to receive anthracycline-free chemotherapy, such as docetaxel, cyclophosphamide, and capecitabine (TCX), as part of routine care or a previous clinical trial.
Drug: Anthracycline-free chemotherapy
Patients who received or are scheduled to receive anthracycline-containing chemotherapy, such as docetaxel, an anthracycline, and cyclophosphamide (TAC), as part of routine care or a previous clinical trial.
Drug: Anthracycline-containing chemotherapy
Received as part of routine clinical care or a previous trial; not assigned by this study.
Also known as: docetaxel, Cyclophosphamide, capecitabine
Received as part of routine clinical care or a previous trial; not assigned by this study.
Also known as: docetaxel, epirubicin, cyclophosphamide
Performance of the prediction model for disease-free survival
Discrimination and calibration of the model for disease-free survival (DFS), assessed with internal validation. DFS is defined as the time from surgery to locoregional or distant recurrence, second primary malignancy, or death from any cause.
Time frame: 5 years after surgery
Overall survival
Time from surgery to death from any cause.
Time frame: 5 years after surgery
Plan to share: No
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.
Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's planned 19 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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