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

NCT ID: NCT02441933

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 878 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

Group Type: ACTIVE_COMPARATOR

Taxane

Intervention Type: 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.

• Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles
• Paclitaxel (80 mg/m2) IV weekly for 12 doses

carboplatin group

Group Type: EXPERIMENTAL

taxane plus carboplatin

Intervention Type: 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.

• Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
• Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles

Interventions

taxane plus carboplatin

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.

• Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
• Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles

Intervention Type: DRUG

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 selected at the investigator's discretion from among the following two regimens.

• Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles
• Paclitaxel (80 mg/m2) IV weekly for 12 doses

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chungbuk university hospital

Cheonju, Chungchung Do, South Korea

National Cancer Center

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

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 37166557 (View on PubMed)

Other Identifiers

4-2015-0074

Identifier Type: -

Identifier Source: org_study_id