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

March 19, 2019 updated by: Yonsei University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

840

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Contact:
      • Daegu, Korea, Republic of
        • Recruiting
        • Keimyung University Dongsan Medical Center
        • Contact:
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
      • Seongnam, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Gangnam Severance Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Catholic University of Korea, Seoul St. Mary's Hospital
        • Contact:
      • Seoul, Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyunghee University Healthcare System
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei Cancer Center at Yonsei University Medical Center
        • Contact:
          • Joo Hyuk Sohn, MD, PhD
          • Phone Number: 82-2-2228-8130
      • Ulsan, Korea, Republic of
        • Recruiting
        • Ulsan University Hospital
        • Contact:
      • Wonju, Korea, Republic of
        • Recruiting
        • Wonju Severance Christian Hospital
        • Contact:
    • Chungchung Do
      • Cheonju, Chungchung Do, Korea, Republic of
    • Gyeonggido
      • Goyang, Gyeonggido, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
      • Ilsan, Gyeonggido, Korea, Republic of
        • Recruiting
        • National Health Insurance Service Ilsan Hospital
        • Contact:
      • Seongnam, Gyeonggido, Korea, Republic of
        • Recruiting
        • Bundang CHA Hospital
        • Contact:
      • Suwon, Gyeonggido, Korea, Republic of
        • Recruiting
        • Ajou universwity Medical Center
        • Contact:
    • Gyungkido
      • Cheonan, Gyungkido, Korea, Republic of
        • Recruiting
        • Soonchunhyang University Cheonan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: control group
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
Experimental: carboplatin group
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year event free survival
Time Frame: 5 year

time from randomization to the occurrence of the following events

: loco-regional recurrence, distant recurrence, death from any cause, contralateral invasive breast cancer, second primary cancer, and clinically inoperable and residual disease at surgery (only in the neoadjuvant population)
5 year

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 year
5 year
Distant recurrence free survival
Time Frame: 5 year
5 year
(loco-regional recurrence free survival
Time Frame: 5 year
5 year
pathologic complete response rate
Time Frame: 5 year
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

May 4, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2015-0074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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