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

  • STATUS
    Recruiting
  • End date
    Mar 23, 2023
  • participants needed
    840
  • sponsor
    Yonsei University
Updated on 23 January 2021
paclitaxel
breast surgery
cyclophosphamide
carcinoma
doxorubicin
anthracyclines
carboplatin
HER2
primary tumor
docetaxel
adjuvant therapy
triple negative breast cancer
erbb2
invasive breast cancer
taxane
mastectomy
lumpectomy
adjuvant chemotherapy
axillary lymph node dissection
immunostimulant
sentinel node
mammogram
female breast cancer
core needle biopsy
sentinel lymph node biopsy
invasive carcinoma

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.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment Taxane, taxane plus carboplatin
Clinical Study IdentifierNCT02441933
SponsorYonsei University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 19 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or Breast Cancer Diagnosis or breast carcinoma or cancer, breast?
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
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/L Platelet count: 10 10/L
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

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
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