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This is a randomized, open-label, multicenter, phase III study comparing anthracyclines followed by taxane to anthracyclines followed by taxane plus carboplatin as (neo)adjuvant therapy in patients with triple-negative breast cancer.
Patients with stage II/III operable triple-negative breast cancer are eligible. Patients who need adjuvant chemotherapy after breast surgery as well as patients who need neoadjuvant chemotherapy for TNBC are eligible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Active Comparator |
| |
| carboplatin group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| taxane plus carboplatin | Drug | Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens.
|
| Measure | Description | Time Frame |
|---|---|---|
| 5-year event-free survival (EFS) | time from Cycle1 Day1 to the occurrence of the following events : loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy | 5 year |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | Time from C1D1 until death from any cause | 5 year |
| Distant recurrence free survival | Time from C1D1 until distant recurrence |
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Inclusion Criteria:
Female patients who are >18 years of age
ECOG 0 or 1
The tumor must be invasive carcinoma of the breast on histologic examination
The tumor must have been determined to be HER2-negative, as follows:
The tumor must have been determined to be ER- and PR-negative, as assessed by the current ASCO/CAP guidelines.
All of the following staging criteria (AJCC 7th edition) must be met:
The patient must have undergone either a mastectomy or lumpectomy in the adjuvant group
The patient must have completed one of the nodal surgery procedures listed below in the adjuvant group:
V If pathologic nodal staging based on SLNB is pN0 V If pathologic nodal staging based on SLNB is 1 or 2 positive nodes, the primary tumor must be T1 or T2 by pathologic evaluation and lumpectomy and the nodal involvement must be limited to 1 or 2 positive nodes
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk university hospital | Cheonju | Chungchung Do | South Korea | |||
| National Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37166557 | Derived | Kim MH, Kim GM, Ahn JM, Ryu WJ, Kim SG, Kim JH, Kim TY, Han HJ, Kim JY, Park HS, Park S, Park BW, Kim SI, Jeong J, Lee J, Paik S, Kim S, Jung KH, Cho EH, Sohn J. Copy number aberrations in circulating tumor DNA enables prognosis prediction and molecular characterization of breast cancer. J Natl Cancer Inst. 2023 Sep 7;115(9):1036-1049. doi: 10.1093/jnci/djad080. |
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|
| Taxane | Drug | Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens.
|
|
| 5 year |
| loco-regional recurrence free survival | Time from C1D1 until locoregional recurrence | 5 year |
| pathologic complete response rate | no evidence of invasive carcinoma in both breast and axillary lymph nodes, regardless of ductal carcinoma in situ (ypT0isN0) | 5 year |
| Goyang |
| Gyeonggido |
| South Korea |
| National Health Insurance Service Ilsan Hospital | Ilsan | Gyeonggido | South Korea |
| Bundang Cha Hospital | Seongnam | Gyeonggido | South Korea |
| Ajou universwity Medical Center | Suwon | Gyeonggido | South Korea |
| Soonchunhyang university Cheonan hospital | Cheonan | Gyungkido | South Korea |
| Inje University Haeundae Paik Hospital | Busan | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Seoul national university Bundang Hospital | Seongnam | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Boramae Medical Center | Seoul | South Korea |
| Catholic university of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Chung Ang University Heaelthcare System | Seoul | South Korea |
| Gangnam Severance hospital | Seoul | South Korea |
| Korea University Anam hospital | Seoul | South Korea |
| Kyunghee University Healthcare System | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Yonsei Cancer Center at Yonsei University Medical Center | Seoul | South Korea |
| Ulsan University Hospital | Ulsan | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C080625 | taxane |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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