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Correlation study between clinical response to standard therapies and ex vivo organoid drug sensitivity in metastatic breast cancer

Correlation study between clinical response to standard therapies and ex vivo organoid drug sensitivity in metastatic breast cancer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-17011405
Enrollment
Unknown
Registered
2017-05-15
Start date
2017-03-01
Completion date
Unknown
Last updated
2017-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Observational Group:Non-interventional

Sponsors

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 years old or more; 2. Breast cancer with synchronous or metachronousmetastases.Histopathologic or cytopathologic confirmed invasive breast cancer with regional lymph node metastasis; 3. Metastasis and/or primitive tumor (in case of synchronous metastases) accessible to biopsy and/or surgery sample; 4. No clinical evidence of other malignancy, unstable complication or uncontrolled infection; 5. Life expectancy > 12 months.6.Informed and signed consent by the patient.

Exclusion criteria

Exclusion criteria: 1. Not accessible to biopsy and/or surgery sample; 2. Patient already enrolled in an other clinical trial with another first line of chemotherapy; 3. Unmeasurable locally advanced (incurable) or metastatic lesion(s), according to RECIST 1.1 criteria; 4. Women who are pregnant, plan to become pregnant or are lactating during the study; 5. Elevation of carcinoembryonic antigen (CEA)observed without distal metastases found; 6. Have some kind of contraindications for chemotherapy and targeted therapy: cardiovascular and cerebrovascular diseases; liver and kidney function deficiency;hematological system diseases;clinician consider the patients are not suitable for chemotherapies or target therapies; 7. Have other malignant tumor previously; 8. Have surgical contraindications:anesthesia taboo;surgery unresectable extensive lesions; 9. State of health can't finish the study; 10. Patient already enrolled in an other clinical trial with another anti-cancer therapy or plan to participate in other clinical study. 11.No self-determination or refuse to participants. 12. With unlisted exclusion criteria but researchers consider not suitable for the clinical study.

Design outcomes

Primary

MeasureTime frame
Size of residual infiltration lesions;

Countries

China

Contacts

Public ContactBailin Zhang

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

bailin_zhang@cicams.ac.cn+86 13910620217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026