Clinical Trials /

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

NCT02441933

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Carboplatin in EARLY Triple Negative Breast Cancer Trial (PEARLY Trial)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 4-2015-0074
  • NCT ID: NCT02441933

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
taxane plus carboplatincarboplatin group
Taxanecontrol group

Purpose

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 Arms

NameTypeDescriptionInterventions
control groupActive Comparator
  • Taxane
carboplatin groupExperimental
  • taxane plus carboplatin

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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:5-year event free survival
Time Frame:5 year
Safety Issue:
Description: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)

Secondary Outcome Measures

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

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Yonsei University

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