Breast Cancer Clinical Trial
Official title:
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
Status | Not yet recruiting |
Enrollment | 587 |
Est. completion date | March 2018 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of breast cancer 1. Female patients 2. Histologically confirmed invasive breast cancer 1. Primary tumor greater than 2cm diameter, measured by mammography and sonography 2. Any N 3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+) 4. No evidence of metastasis (M0) 5. No prior hormonal, chemotherapy or radiotherapy is allowed. 6. No breast operation other than biopsy to make diagnosis is allowed. 7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1) 8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3 9. Adequate renal function: Serum creatinine 1.5 mg/dl 10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal 11. Written informed consent 12. Normal mental function to understand and sign the consent 13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment. 14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment Exclusion Criteria: 1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer 2. Patients who underwent surgery for breast cancer 3. Patients with a history of uncompensated congestive heart failure 4. Patients with inflammatory breast cancer (T4d) 5. Patients without primary tumor (T0) 6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer 7. Known hypersensitivity to any of the study drugs |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Severance Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | difference in gene expression pattern | up to 5 years | No | |
Primary | Disease-free survival (DFS) | To compare DFS between carboplatin and observation within non-pCR (complete remission) patients | up to 3 years | Yes |
Secondary | overall survival | To compare overall survival (OS) between carboplatin and observation within non-pCR patients. | up to 5years | Yes |
Secondary | pCR rate | To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients. | up to 3 years | Yes |
Secondary | The percentage of patients who receive breast conserving surgery. | To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients | up to 3years | Yes |
Secondary | Number of adverse events | Number of adverse events in patients with non-pCR. | up to 3years | Yes |
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