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

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02441933
• Collaborator: (none)
• Enrollment: 840
• Locations: 21
• Arms: 2
• Anticipated Duration (Months): 87
• Patients Per Site: 40
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Dec 1, 2015
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 5-year event free survival [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 [5 year]

2. Distant recurrence free survival [5 year]

3. (loco-regional recurrence free survival [5 year]

4. pathologic complete response rate [5 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. The tumor must have been determined to be ER- and PR-negative, as assessed by the current ASCO/CAP guidelines.

2. 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)

1. The patient must have undergone either a mastectomy or lumpectomy in the adjuvant group

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chungbuk university hospital	Cheonju	Chungchung Do	Korea, Republic of
2	National Cancer Center	Goyang	Gyeonggido	Korea, Republic of
3	National Health Insurance Service Ilsan Hospital	Ilsan	Gyeonggido	Korea, Republic of
4	Bundang Cha Hospital	Seongnam	Gyeonggido	Korea, Republic of
5	Ajou universwity Medical Center	Suwon	Gyeonggido	Korea, Republic of
6	Soonchunhyang university Cheonan hospital	Cheonan	Gyungkido	Korea, Republic of
7	Inje University Haeundae Paik Hospital	Busan		Korea, Republic of
8	Keimyung University Dongsan Medical Center	Daegu		Korea, Republic of
9	Gachon University Gil Medical Center	Incheon		Korea, Republic of
10	Seoul national university Bundang Hospital	Seongnam		Korea, Republic of
11	Asan Medical Center	Seoul		Korea, Republic of
12	Boramae Medical Center	Seoul		Korea, Republic of
13	Catholic university of Korea, Seoul St. Mary's Hospital	Seoul		Korea, Republic of
14	Chung Ang University Heaelthcare System	Seoul		Korea, Republic of
15	Gangnam Severance hospital	Seoul		Korea, Republic of
16	Korea University Anam hospital	Seoul		Korea, Republic of
17	Kyunghee University Healthcare System	Seoul		Korea, Republic of
18	Samsung Medical Center	Seoul		Korea, Republic of
19	Yonsei Cancer Center at Yonsei University Medical Center	Seoul		Korea, Republic of
20	Ulsan University Hospital	Ulsan		Korea, Republic of
21	Wonju Severance Christian Hospital	Wonju		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02441933
• Other Study ID Numbers: 4-2015-0074
• First Posted: May 12, 2015
• Last Update Posted: Mar 20, 2019
• Last Verified: Mar 1, 2019

• Additional relevant MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms; Carboplatin; Taxane

Study Results

No Results Posted as of Mar 20, 2019