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

Yonsei University

Status and phase: Active, not recruiting; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Taxane; Drug: taxane plus carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02441933

4-2015-0074

Details and patient eligibility

About

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.

Enrollment: 878 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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 average HER2 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 the current 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 size must be >2.0 cm (* In the neoadjuvant group, if there is evidence of suspicious axillary 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 adjuvant group

8. The patient must have completed one of the nodal surgery procedures listed below in the 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 baseline LN NAB or core biopsy is positive, ALND should be performed) 9) LVEF assessment by echocardiography or MUGA scan must be >50%, regardless of the cardiac imaging facility'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 the Cockcroft formula
• Hepatic function Total Bilirubin: ≤ 1.5 × UNL AST/ALT: ≤ 2.5 × UNL 10) Ability and willingness to comply with the study visits, treatment, testing, and with the protocol, 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-melanoma skin 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), and other solid tumors curatively treated with no evidence of disease for >5 years prior to randomization.
6. Simultaneous bilateral breast cancer
7. Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
8. Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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878 participants in 2 patient groups

control group

Active Comparator group

Treatment:

Drug: Taxane

carboplatin group

Experimental group

Treatment:

Drug: taxane plus carboplatin