Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial)
A Randomized, Multicenter, Open-label, Phase III Trial Comparing Anthracyclines Followed by Taxane Versus Anthracyclines Followed by Taxane Plus Carboplatin as (Neo) Adjuvant Therapy in Patients With Triple-negative Breast Cancer
1 other identifier
interventional
878
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Sep 2015
Longer than P75 for phase_3 breast-cancer
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 12, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 4, 2024
May 1, 2024
9.8 years
May 4, 2015
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
overall survival
5 year
Distant recurrence free survival
5 year
loco-regional recurrence free survival
5 year
pathologic complete response rate
5 year
Study Arms (2)
control group
ACTIVE COMPARATORcarboplatin group
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may qualify if:
- 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:
- 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
- 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:
- 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)
- 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:
- 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
- +5 more criteria
You may not qualify if:
- Any prior systemic treatment for primary invasive breast cancer
- cT4 or pT4 tumors including inflammatory breast cancer
- Occult breast cancer
- Evidence of metastatic breast cancer
- 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.
- Simultaneous bilateral breast cancer
- Patients considered a poor medical risk due to a serious, uncontrolled medical disorder or uncontrolled infection.
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
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
Related Publications (1)
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.
PMID: 37166557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2015
First Posted
May 12, 2015
Study Start
September 1, 2015
Primary Completion
June 30, 2025
Study Completion
June 30, 2025
Last Updated
June 4, 2024
Record last verified: 2024-05