None listed
Conditions
Interventions
Drug : 1. Control arm (AC followed by taxane)
: 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 selecte
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Female patients must be =19 years of age 2) ECOG 0 or 1 3) Histologically confirmed invasive primary breast cancer 4) Triple negative breast cancer: ER negative, PR negative, HER2 negative - ER and PR neative definedas IHC nuclear staining 2cm by radiographical or clinical measurement (cT2-4N0) : Inflammatory breast cancer (cT4d) would be excluded. - Adjuvant group ? ¦ Lymph node positive breast cancer regardless of tumor size (cT1-4N1-3), N1mi is considered as pN1 and N0i+ is considered as pN0. Patient with pT1N1mi (stage IB) would be excluded. ? ¦ Lymph node negative breast cancer with primary tumor size > 2cm by radiographical or clinical measurement (pT2-4N0) : Inflammatory breast cancer (T4d) would be excluded. Patient with pT4 could be eligible only if the radiation therapy is planned. 6) In adjuvant group, completed adequate breast and axilla surgery defined as: - The inked margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ. - The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below. ? ¦ Axillary Lymph Node Dissection (ALND) with or without sentinel lymph node biopsy (SLNB) ? ¦ SLNB alone: If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or if all of the followings are fullfiled: ? ? 1 or 2 positive nodes ? ? Breast conserving surgery ? ? Planned breast radiotherapy ? ? pT1-2 7) Radomization must be performed no longer than 8 weeks from definitive surgery in adjuvant group 8) Patient must have adequate organ function measured within 7days prior to AC chemotherapy as defined below - Marrow function ? ¦ Hemoglobin: = 10.0 g/dl ? ¦ ANC: = 1,500 / µl ? ¦ Platelet: = 10 × 104/ µl - Kidney function ? ¦ Creatinine: = 1.5 x Upper Normal Limit (UNL) or ? ¦ Creatinine clearance (Ccr) = 50 ml/min by Cockroft formula - Liver function ? ¦ Total Bilirubin: = 1.5 × UNL ? ¦ AST/ALT: = 2.5 × UNL 9) Patients is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination
Exclusion criteria
Exclusion criteria: 1) Any previous history of invasive breast cancer 2) Any prior systemic therapy (chemotherapy, endocrine therapy, targeted therapy) for cancer, including breast cancer 3) Any local treatment for breast cancer, though patients with curatively treated DCIS or LCIS by surgery are allowed. 4) Inflammatory breast cancer 5) Simultaneous bilateral breast cancer 6) Occult breast cancer 7) Definitive clinical or radiological evidence of metastatic disease 8) Patients with second primary cancers within 5 years from randomization; Exceptions: adequately treated non-melanoma skin cancer, curatively treated cervix in situ cancer, DCIS or LCIS of the breast, thyroid cancer with a size of 5 years prior to randomization 9) Patients with known active Hepatitis B or C, or HIV. In healthy HBV carriers, a serology test or HBV DNA test performed based on the guidelines of each institute must confirm that it is not active hepatitis. 10) Pregnant or breastfeeding women 11) Known hypersensitivity to any of the study drugs or excipients 12) Peripheral neuropathy grade = 2 by NCI-CTCAE v4.03 13) Severe cardiopulmonary dysfunction, uncontrolled infection, or serious illness or medical conditions 14) Patients who are not adequate for this trial by investigator’s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS): Time from C1D1 until the following events; loco-regional recurrence, distant recurrence, contralateral second primary breast cancer, second primary cancer other than breast cancer, death from any cause, residual cancer after surgery (not R0 resection), definitive disease progression during neoadjuvant chemotherapy, inoperable status after neoadjuvant chemotherapy;Safety and tolerability | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS): Time from C1D1 until death from any cause;Distant recurrence free survival (DRFS): Time from C1D1 until distant recurrence;Invasive disease-free survival (IDFS): Time from C1D1 until one of the following events (loco-regional recurrence, distant recurrence, contralateral second primary breast cancer, death from any cause);Loco-regional recurrence-free survival (LRFS): Time from C1D1 until locoregional recurrence;Rate of pathologically complete remission (pCR): no evidence of invasive carcinoma in both breast and axillary lymph nodes, regardless of ductal carcinoma in situ (ypT0isN0);SLNB success rate in patients who are not suspicious for axillary LN metastasis before surgery;Rate of axillary lymph node pCR in patients with cytologically confirmed axillary lymph node metastasis | — |
Countries
Korea, Republic of
Contacts
Public ContactJoohyuk Sohn
Yonsei University Health System, Severance Hospital
Outcome results
None listed