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

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ClinicalTrials.gov Identifier: NCT02441933
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: taxane plus carboplatin Drug: Taxane Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2015
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Carboplatin

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




Primary Outcome Measures :
  1. 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)



Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 year ]
  2. Distant recurrence free survival [ Time Frame: 5 year ]
  3. (loco-regional recurrence free survival [ Time Frame: 5 year ]
  4. pathologic complete response rate [ Time Frame: 5 year ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441933


Locations
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Korea, Republic of
Chungbuk university hospital Recruiting
Cheonju, Chungchung Do, Korea, Republic of
Contact: Ki Hyeong Lee, MD, PhD       kihlee@chungbuk.ac.kr   
National Cancer Center Recruiting
Goyang, Gyeonggido, Korea, Republic of
Contact: Keun Seok Lee, MD, PhD       ksleemd@gmail.com   
National Health Insurance Service Ilsan Hospital Recruiting
Ilsan, Gyeonggido, Korea, Republic of
Contact: Soo Jung Hong, Md, PhD       suzzy901@nhimc.or.kr   
Bundang Cha Hospital Recruiting
Seongnam, Gyeonggido, Korea, Republic of
Contact: Yong Hwa Moon, MD, PhD       ymoon@cha.ac.kr   
Ajou universwity Medical Center Recruiting
Suwon, Gyeonggido, Korea, Republic of
Contact: Seok Yun Kang, MD       kangsy01@ajou.ac.kr   
Soonchunhyang university Cheonan hospital Recruiting
Cheonan, Gyungkido, Korea, Republic of
Contact: Han Jo Kim, MD       hzmd@schmc.ac.kr   
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of
Contact: Sung Sook Lee, Md, PhD       H00285@paik.ac.kr   
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Keon Uk Park, MD, PhD       kupark@dsmc.or.kr   
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Eun Kyung Cho, MD, PhD       ekcho@gilhospital.com   
Seoul national university Bundang Hospital Recruiting
Seongnam, Korea, Republic of
Contact: Se Hyun Kim, MD       sehyunkim@snubh.org   
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyung Hae Jung, Md, PhD       khjung@amc.seoul.kr   
Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Jin Hyun Park, MD       jinhyunpak@gmail.com   
Catholic university of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ji Eun Lee, MD, PhD       befamiliar@naver.com   
Chung Ang University Heaelthcare System Recruiting
Seoul, Korea, Republic of
Contact: Hee Jun Kim, MD, PhD       heejun.dino11@gmail.com   
Gangnam Severance hospital Recruiting
Seoul, Korea, Republic of
Contact: Hei Cheul Jeung, Md, PhD       jeunghc1123@yuhs.ac   
Korea University Anam hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyong Hwa Park, MD, PhD       khpark@korea.ac.kr   
Kyunghee University Healthcare System Recruiting
Seoul, Korea, Republic of
Contact: Sun Kyung Baek, MD       wkiki@naver.com   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young Hyuck Im, MD, PhD       imyh00@skku.edu   
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo Hyuk Sohn, MD, PhD    82-2-2228-8130      
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Su Jin Koh, MD, PhD       sujinkoh@daum.net   
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Seung Taek Lim, MD       darksgtlim@naver.com   
Sponsors and Collaborators
Yonsei University

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02441933     History of Changes
Other Study ID Numbers: 4-2015-0074
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Taxane
Antineoplastic Agents