Last reviewed · How we verify
NCT01116869
China CellSearch Study
trial in Metastatic Breast Cancer in 500 participants. Completed in 6 January 2014.
22 June 2011
Quick facts
| Lead sponsor | Johnson & Johnson Medical, China |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 500 |
| Start date | 25 March 2010 |
| Primary completion | 22 June 2011 |
| Estimated completion | 6 January 2014 |
| Sites | 1 location across China |
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
- Benign Breast Disease — all drugs for Benign Breast Disease →
Sponsor
Johnson & Johnson Medical, China
Who can join
Adults 18 to 70, female only, with Metastatic Breast Cancer or Benign Breast Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is designed to confirm the current indication (below) of the CellSearch® Circulating Tumor Cell Kit in metastatic breast cancer (MBC) patients for use of the kit in China. The CellSearch® Circulating Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch® Circulating Tumor Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer. This test is to be used as an aid in the monitoring of patients with metastatic breast cancer. Serial testing for CTC should be used in conjunction with other clinical methods for monitoring metastatic breast cancer. Evaluation of CTC at any time during the course of disease allows assessment of patient prognosis and is predictive of progression free survival and overall survival.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of Epithelial-to-Mesenchymal Transition for the Generation of Circulating Tumors Cells and Cancer Cell Dissemination.
Noubissi Nzeteu GA, Geismann C, Arlt A, Hoogwater FJH, et al · · 2022 · cited 18× · PMID 36428576 · DOI 10.3390/cancers14225483 -
Clinical Validity of Repeated Circulating Tumor Cell Enumeration as an Early Treatment Monitoring Tool for Metastatic Breast Cancer in the PREDICT Global Pooled Analysis.
Janni W, Friedl TWP, Yab TC, Bidard FC, et al · · 2025 · cited 12× · PMID 40100138 · DOI 10.1158/1078-0432.ccr-24-3108
Verify or expand the search:
- PubMed search for NCT01116869
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
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- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other Johnson & Johnson Medical, China trials
Trials by the same sponsor.
- NCT03305887 — Symmetric on Total Knee Arthroplasty (TKA) · NA · completed
- NCT02810522 — OneTouch Select® [Brand Name]Plus Blood Glucose Monitoring System(BGMS) Registration Study · NA · withdrawn
- NCT01795625 — OneTouch® Verio™Pro+ Blood Glucose Monitoring System Clinical Accuracy Study in China · completed
- NCT01878981 — Health Economics Evaluation of Catheter Ablation Versus Drug Therapy in Atrial Fibrillation (AF) in China · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01116869 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johnson & Johnson Medical, China
- Last refreshed: 15 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01116869.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing