Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial)

Inclusion Criteria:

1. Female patients who are >18 years of age

2. ECOG 0 or 1

3. The tumor must be invasive carcinoma of the breast on histologic examination

4. The tumor must have been determined to be HER2-negative, as follows:

• IHC 0 or 1+; or

• IHC 2+ and ISH non-amplified, with a ratio of <2.0, and if reported, an averageHER2 gene copy number of <6 signals/cell; or

• ISH non-amplified without IHC

5. The tumor must have been determined to be ER- and PR-negative, as assessed by thecurrent ASCO/CAP guidelines.

6. All of the following staging criteria (AJCC 7th edition) must be met:

• Lymph node-positive disease: cytologically positive in the neoadjuvant group*and pathologically positive in the adjuvant group

• If the lymph node is cytologically or pathologically negative, the tumor sizemust be >2.0 cm (* In the neoadjuvant group, if there is evidence of suspiciousaxillary lymph nodes at the baseline imaging study or physical examination,then FNA or core biopsy is required to confirm the nodal status)

7. The patient must have undergone either a mastectomy or lumpectomy in the adjuvantgroup

8. The patient must have completed one of the nodal surgery procedures listed below inthe adjuvant group:

• Sentinel lymph node biopsy (SLNB) alone:

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

• SLNB followed by removal of additional non-sentinel LNs if the SLN is positive; or

• Axillary lymphadenectomy with or without SLNB (In the neoadjuvant group, if baselineLN NAB or core biopsy is positive, ALND should be performed) 9) LVEF assessment byechocardiography or MUGA scan must be >50%, regardless of the cardiac imagingfacility's lower limit of normal 10) The patient must have adequate hepatic, renal,and bone marrow function;

• Bone marrow function Hb: ≥ 10.0 g/dL ANC: ≥ 1,500/µL Platelet count: ≥ 10 × 10⁴/µL

• Renal function Creatinine: ≤ 1.5 × UNL or Creatine clearance (Ccr) >50 ml/min by theCockcroft formula

• Hepatic function Total Bilirubin: ≤ 1.5 × UNL AST/ALT: ≤ 2.5 × UNL 10) Ability andwillingness to comply with the study visits, treatment, testing, and with theprotocol, as per investigator's judgment

Exclusion Criteria:

1. Any prior systemic treatment for primary invasive breast cancer

2. cT4 or pT4 tumors including inflammatory breast cancer

3. Occult breast cancer

4. Evidence of metastatic breast cancer

5. Patients with second primary cancer; EXCEPTIONS: adequately treated non-melanomaskin cancer, curatively treated in situ cancer of the cervix, DCIS of the breast,thyroid cancer with a size of <2 cm (papillary, follicular, and medullary type), andother solid tumors curatively treated with no evidence of disease for >5 years priorto randomization.

6. Simultaneous bilateral breast cancer

7. Patients considered a poor medical risk due to a serious, uncontrolled medicaldisorder or uncontrolled infection.

8. Pregnant or breastfeeding women