Status:
UNKNOWN
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC). CREATE-X clinical studi...
Detailed Description
The investigators will recruit patients who had low- hormone receptor (HR)positive breast cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological complete response,...
Eligibility Criteria
Inclusion
- Provision of informed consent
- Women and men at least 18 years of age or older.
- Pathological confirmation of breast cancer
- Tumor stage(TNM): T1-4N0-3M0
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
- Measurable disease as per RECIST criteria
- Karnofsky≥70
- Laboratory criteria:
- PLT≥100\*109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST\<2\*ULN
Exclusion
- Presence of metastatic disease.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- Postoperative treatment with other adjuvant chemotherapy drugs.
- Other malignant tumors (concurrent or previous).
- Pregnant woman.
- Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine.
- Any severe systemic disease contraindicating chemotherapy.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03821454
Start Date
February 1 2019
End Date
February 1 2021
Last Update
February 1 2019
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