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Study Comparing the Efficacy and Safety of EC-T Verses PCb in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer (PANSY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193059
Recruitment Status : Recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zhimin Shao, Fudan University

Brief 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 (EC*4-T*4) 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Paclitaxel Drug: Carboplatin Drug: Epirubicin Drug: Cyclophosphamide Drug: Trastuzumab (qw) Drug: Trastuzumab (q3w) Drug: Docetaxel Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

PANSY-1:

Arm 1: 4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m2 ivgtt d1, 21 days per cycle) ; Arm 2: 6 cycles of weekly PCb (paclitaxel 80 mg/m2 ivgtt d1, d8, d15+ carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle).

PANSY-2:

Arm 1: 4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m2 ivgtt d1 + trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle); Arm 2: 6 cycles of weekly PCb (paclitaxel 80 mg/m2 ivgtt d1, d8, d15 + carboplatin AUC=2 ivgtt d1, d8, d15 + trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle). After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).

Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Treatment
Official Title: Study Comparing the Efficacy and Safety of Epirubicin Combined With Cyclophosphamide Followed by Docetaxel (EC-T) Verses Paclitaxel Combined With Carboplatin (PCb) in the Adjuvant Chemotherapy of Non-triple Negative Breast Cancer
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: PANSY-1: EC-T
4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+ cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m2 ivgtt d1, 21 days per cycle)
Drug: Epirubicin
epirubicin 90 mg/m2 ivgtt d1, 21 days per cycle, 4 cycles.

Drug: Cyclophosphamide
cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle, 4 cycles.

Drug: Docetaxel
docetaxel 100 mg/m2 ivgtt d1, 21 days per cycle, 4 cycles.

Experimental: PANSY-1: PCb
6 cycles of weekly PCb (paclitaxel 80 mg/m2 ivgtt d1, d8, d15+ carboplatin Area Under Curve (AUC)=2 ivgtt d1, d8, d15, 28 days per cycle)
Drug: Paclitaxel
paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

Drug: Carboplatin
carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

Active Comparator: PANSY-2: EC-TH
4 cycles of EC (epirubicin 90 mg/m2 ivgtt d1+cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle), followed by 4 cycles of TH (docetaxel 100 mg/m2 ivgtt d1 + trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle). After 8 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
Drug: Epirubicin
epirubicin 90 mg/m2 ivgtt d1, 21 days per cycle, 4 cycles.

Drug: Cyclophosphamide
cyclophosphamide 600 mg/m2 iv d1, 21 days per cycle, 4 cycles.

Drug: Trastuzumab (q3w)
trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle, 4 cycles. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).

Drug: Docetaxel
docetaxel 100 mg/m2 ivgtt d1, 21 days per cycle, 4 cycles.

Experimental: PANSY-2: PCbH
6 cycles of weekly PCbH (paclitaxel 80 mg/m2 ivgtt d1, d8, d15 + carboplatin AUC=2 ivgtt d1, d8, d15 + trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle). After 6 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
Drug: Paclitaxel
paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

Drug: Carboplatin
carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

Drug: Trastuzumab (qw)
trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle, 6 cycles. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).




Primary Outcome Measures :
  1. disease free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. invasive disease free survival [ Time Frame: 5 years ]
  2. distant disease free survival [ Time Frame: 5 years ]
  3. overall survival [ Time Frame: 5 years ]
  4. adverse effects [ Time Frame: 5 years ]
    Graded according to Common Terminology Criteria for Adverse Events (CTC-AE) 4.0 according to CTC-AE 4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female patients aged 18-70 years old;
  2. Histologically confirmed unilateral invasive breast cancer (regardless of pathological type)
  3. Operable breast cancer at first diagnosis, without any absolute surgical contraindication.
  4. No gross nor microscopic residual tumor after surgery.
  5. Begins adjuvant chemotherapy within four weeks after surgery.
  6. 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.
  7. Preoperative examination found no evidence of metastasis in clinical examination nor imaging examination.
  8. No peripheral neuropathy.
  9. Karnofsky score > 70.
  10. Good postoperative recovery, at least 1 week has passed since most recent surgery.
  11. Has adequate bone marrow function: leukocyte count > 4x10ˆ9 / L, absolute neutrophil count > 2x10ˆ9 /L; platelet count > 100x10ˆ9 /L, hemoglobin > 9g/dL.
  12. Has adequate liver function: alanine aminotransferase (ALT) < 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) < 1.5×ULN, alkaline phosphatase (AKP) < 2.5×ULN, total bilirubin (TBIL) < 1.5×ULN.
  13. Has adequate kidney function: serum creatinine < 1.5×ULN.
  14. Contraception during treatment for women of childbearing age.
  15. Has adequate cardiac function: echocardiography showed left ventricular ejection fraction (LVEF) > 50%.
  16. 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:

  1. Has received previous chemotherapy for late stage disease.
  2. Has bilateral breast cancer or bilateral carcinoma in situ.
  3. Has metastatic (Stage 4) breast cancer.
  4. Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer).
  5. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy).
  6. Has previous history of additional malignancy(with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer.
  7. Is already participating in another clinical trial.
  8. Has severe systemic disease and/or uncontrolled infection.
  9. Has insufficient cardiac function: echocardiography showed LVEF< 50%.
  10. 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.
  11. Has known allergy to chemotherapy drugs used in this study.
  12. 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.
  13. Has entered the study, but pre-treatment examination showed a positive pregnancy test.
  14. 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.
  15. The researchers judged patients to be unsuitable for the study.

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): NCT04193059


Contacts
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Contact: ZhiMin Shao, MD, PhD +86-21-64175590 ext 8808 zhimingshao@yahoo.com

Locations
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China, Shanghai
Cancer Hospital Affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Zhimin Shao, MD, PhD    +86-021-64175590 ext 8888    zhimingshao@yahoo.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: ZhiMin Shao, MD, PhD Fudan University

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Responsible Party: Zhimin Shao, Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT04193059    
Other Study ID Numbers: 2018-68-1461
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhimin Shao, Fudan University:
adjuvant chemotherapy
epirubicin
cyclophosphamide
docetaxel
paclitaxel
carboplatin
trastuzumab
non-triple negative breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Trastuzumab
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors