Study Comparing EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 23, 2024
  • participants needed
    1560
  • sponsor
    Fudan University
Updated on 23 January 2021
paclitaxel
cyclophosphamide
estrogen
growth factor
progesterone
metastasis
carboplatin
pertuzumab
immunohistochemistry
tumor cells
epidermal growth factor receptor
HER2
EGFR
docetaxel
trastuzumab
triple negative breast cancer
progesterone receptor
erbb2
epidermal growth factor
estrogen receptor
cish
invasive breast cancer
epirubicin
adjuvant chemotherapy
immunostimulant
mammogram
chromogenic in situ hybridization

Summary

This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC4-T4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with 4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with 1 positive lymph node.

Description

PANSY-1 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC-T) verses six cycles of paclitaxel combined with carboplatin (PCb).

PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab (EC-TH) verses six cycles of paclitaxel combined with carboplatin and trastuzumab (PCbH); both followed by 1 year adjuvant trastuzumab.

After pertuzumab became legally available in China, participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy, thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab (EC-THP) verses six cycles of paclitaxel combined with carboplatin, trastuzumab and pertuzumab (PCbHP); both followed by 1 year adjuvant trastuzumab and pertuzumab.

With the inclusion of pertuzumab in China's medical insurance in January 2020, study protocols were revised to include dual targeted therapy for HER2-positive participants.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment cyclophosphamide, docetaxel, carboplatin, Epirubicin, Paclitaxel, Trastuzumab, Pertuzumab, Trastuzumab (qw), Trastuzumab (q3w)
Clinical Study IdentifierNCT04193059
SponsorFudan University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 70 yrs?
Are you female?
Do you have Breast Cancer?
Do you have any of these conditions: Breast Cancer or cancer, breast or Breast Cancer Diagnosis or breast carcinoma?
Female patients aged 18-70 years old
Histologically confirmed unilateral invasive breast cancer (regardless of pathological type)
Operable breast cancer at first diagnosis, without any absolute surgical contraindication
No gross nor microscopic residual tumor after surgery
HER2-positive with 1 positive axillary lymph node; or estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative with 4 positive axillary lymph node. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or a positive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistry showing that 1% of tumor cells were ER positive. PR-positive is defined as immunohistochemistry showing that 1% of tumor cells were PR positive
Preoperative examination found no evidence of metastasis in clinical examination nor imaging examination
No peripheral neuropathy
Karnofsky score > 70\
Good postoperative recovery, at least 1 week has passed since most recent surgery
Has adequate bone marrow function: leukocyte count > 4x109 / L, absolute neutrophil count > 2x109 /L; platelet count > 100x109 /L, hemoglobin > 9g/dL
Has adequate liver function: alanine aminotransferase (ALT) < 1.5upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5ULN, alkaline phosphatase (AKP) < 2.5ULN, total bilirubin (TBIL) < 1.5ULN
Has adequate kidney function: serum creatinine < 1.5ULN
Contraception during treatment for women of childbearing age
Has adequate cardiac function: echocardiography showed left ventricular ejection fraction (LVEF) > 50%
Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up

Exclusion Criteria

Has received previous chemotherapy for late stage disease
Has bilateral breast cancer or bilateral carcinoma in situ
Has metastatic (Stage 4) breast cancer
Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer)
Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy)
Has previous history of additional malignancy(with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer
Is already participating in another clinical trial
Has severe systemic disease and/or uncontrolled infection
Has insufficient cardiac function: echocardiography showed LVEF< 50%
Has suffered from severe cardiovascular and cerebrovascular diseases disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure>150/90 mmHg, myocardial infarction, or cerebrovascular accident
Has known allergy to chemotherapy drugs used in this study
Is pregnant, is breast feeding, or is a woman of childbearing age who cannot practice effective contraceptives during treatment and until 8 weeks after the end of treatment
Has entered the study, but pre-treatment examination showed a positive pregnancy test
Has a history of mental disorders, cognitive impairment, inability to understand the study protocol and side effects, inability to complete the study protocol and follow-up workers (systematic evaluation is required before the patient is enrolled into the study), or is without independent civil capacity
The researchers judged patients to be unsuitable for the study
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