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

NCT04193059 | Active Not Recruiting Phase 3

• 1 other identifier: 2018-68-1461
• Study Type: interventional
• Target: 1,560
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

adjuvant chemotherapy; epirubicin; cyclophosphamide; docetaxel; paclitaxel; carboplatin; trastuzumab; non-triple negative breast cancer; pertuzumab

Outcome Measures

Primary Outcomes (1)

• disease free survival

  5 years

Secondary Outcomes (4)

• Invasive Disease Free Survival

  5 years

• Distant Disease Free Survival

  5 years

• Overall Survival

  5 years

• Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0

  5 years

Study Arms (4)

PANSY-1: EC-T

ACTIVE COMPARATOR

4 cycles of EC (epirubicin 90 mg/m\^2 ivgtt d1+ cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle), followed by 4 cycles of T (docetaxel 100 mg/m\^2 ivgtt d1, 21 days per cycle)

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Docetaxel

PANSY-1: PCb

EXPERIMENTAL

6 cycles of weekly PCb (paclitaxel 80 mg/m\^2 ivgtt d1, d8, d15+ carboplatin Area Under Curve (AUC)=2 ivgtt d1, d8, d15, 28 days per cycle)

Drug: Paclitaxel; Drug: Carboplatin

PANSY-2: EC-TH(P)

ACTIVE COMPARATOR

4 cycles of EC (epirubicin 90 mg/m\^2 ivgtt d1+cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle), followed by 4 cycles of TH(P) (docetaxel 100 mg/m\^2 ivgtt d1 + trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). After 8 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy.

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel

PANSY-2: PCbH(P)

EXPERIMENTAL

6 cycles of weekly PCbH(P) (paclitaxel 80 mg/m\^2 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, with pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle for participants receiving dual-targeted therapy). Participants may also choose to receive trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy. After 6 cycles of chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks), with pertuzumab (420mg ivgtt every 3 weeks) for participants receiving dual-targeted therapy.

Drug: Paclitaxel; Drug: Carboplatin; Drug: Trastuzumab; Drug: Pertuzumab

Interventions

Paclitaxel DRUG

paclitaxel 80 mg/m\^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.

PANSY-1: PCb; PANSY-2: PCbH(P)

Carboplatin DRUG

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

PANSY-1: PCb; PANSY-2: PCbH(P)

Epirubicin DRUG

epirubicin 90 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.

PANSY-1: EC-T; PANSY-2: EC-TH(P)

Cyclophosphamide DRUG

cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle, 4 cycles.

PANSY-1: EC-T; PANSY-2: EC-TH(P)

Trastuzumab DRUG

trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).

PANSY-2: EC-TH(P); PANSY-2: PCbH(P)

Pertuzumab DRUG

pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).

PANSY-2: EC-TH(P); PANSY-2: PCbH(P)

Docetaxel DRUG

docetaxel 100 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.

PANSY-1: EC-T; PANSY-2: EC-TH(P)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \> 4x10ˆ9 / L, absolute neutrophil count \> 2x10ˆ9 /L; platelet count \> 100x10ˆ9 /L, hemoglobin \> 9g/dL.
• 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.
• Has adequate kidney function: serum creatinine \< 1.5×ULN.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Epirubicin; Cyclophosphamide; Trastuzumab; pertuzumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• ZhiMin Shao, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Key Laboratory of Breast Cancer in Shanghai, Department of Breast Surgery

Model Details: PANSY-1: Arm 1: EC-T: 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of T (docetaxel) . Arm 2: PCb: 6 cycles of weekly PCb (paclitaxel + carboplatin). PANSY-2: Arm 1: EC-TH(P): 4 cycles of EC (epirubicin + cyclophosphamide), followed by 4 cycles of TH TH(P) (docetaxel + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy). After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. Arm 2: PCbH(P): 6 cycles of weekly PCbH(P) (paclitaxel + carboplatin + trastuzumab, with pertuzumab for participants receiving dual-targeted therapy. After completing chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab, with pertuzumab for participants receiving dual-targeted therapy.

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 10, 2019
• Study Start: December 20, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-10

Locations

CN (1)