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
Overview
- Phase
- Phase 3
- Intervention
- carboplatin
- Conditions
- Breast Cancer
- Sponsor
- Severance Hospital
- Enrollment
- 587
- Primary Endpoint
- Disease-free survival (DFS)
- Last Updated
- 13 years ago
Overview
Brief Summary
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.
Detailed Description
In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals. In POST Neo-adjuvant period Randomization: At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
Investigators
Byeong Woo Park
Principal Investigator
Severance Hospital
Eligibility Criteria
Inclusion Criteria
- •Clinical diagnosis of breast cancer
- •Female patients
- •Histologically confirmed invasive breast cancer
- •Primary tumor greater than 2cm diameter, measured by mammography and sonography
- •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+)
- •No evidence of metastasis (M0)
- •No prior hormonal, chemotherapy or radiotherapy is allowed.
- •No breast operation other than biopsy to make diagnosis is allowed.
- •Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- •Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
Exclusion Criteria
- •Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- •Patients who underwent surgery for breast cancer
- •Patients with a history of uncompensated congestive heart failure
- •Patients with inflammatory breast cancer (T4d)
- •Patients without primary tumor (T0)
- •Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
- •Known hypersensitivity to any of the study drugs
Arms & Interventions
carboplatin chemotherapy
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
Intervention: carboplatin
Outcomes
Primary Outcomes
Disease-free survival (DFS)
Time Frame: up to 3 years
To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
Secondary Outcomes
- overall survival(up to 5years)
- pCR rate(up to 3 years)
- The percentage of patients who receive breast conserving surgery.(up to 3years)
- Number of adverse events(up to 3years)