Efficacy and Safety of Neoadjuvant DC-T in Breast Cancer Patients

Study Overview
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Brief Summary
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This is a multicentric, open-label,non-randomized concurrent control, 1:1 match,non-inferiority trial that assesses the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in breast cancer patients.

Detailed Description
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OBJECTIVES: Determine the efficacy and safety of neoadjuvant chemotherapy regimen DC-T and EC-T in suitable breast cancer patients. Participants are randomized to 1 of 2 treatment arms. Arm I: Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery. Arm II: Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery. Patients in arms I and II will undergo physical examination, MRI, estimating of side effects every 4 cycles referring to RECIST (Response Evaluation Criteria In Solid Tumor) guideline. To adjust for potential bias, patients in DC-T arm were matched 1:1 to patients in the EC-T arm based on Her-2 and ER status. After finishing 8 cycles of neoadjuvant chemotherapy, every patient will receive mastectomy or breast-conserving surgery and then assess the pCR rate of primary lesion and axillary lymph nodes. Adjuvant radiotherapy and endocrine therapy will be taken if necessary. Every patient will be followed-up for five years to monitor survival condition.

Official Title
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The Efficacy and Safety of Neoadjuvant Pegylated Liposomal Doxorubicin Plus Cyclophosphamide Followed by Docetaxel in Breast Cancer Patients: A Multicentric, Open-label, Non-randomized Concurrent Control, Non-inferiority Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Pegylated liposomal doxorubicin
* Drug: Cyclophosphamide
* Drug: Epirubicin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged : 18 70 years. WHO (ECOG) performance status 0-2. Patients who have read and understand the informed consent form and have given written informed consent. Diagnosed as invasive breast cancer by core biopsy Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy. Patients had previously not received chemotherapy，radiotherapy or biotherapy. Normal organ function，meeting the requirement of laboratory testing below: WBC≥4.0×109/L, NEU≥1.5×109/L, PLT≥100×109/L, HB ≥10g/dL, Scr≤1.5× ULN, AST ≤2.5×ULN, ALT ≤2.5×ULN, TDIL≤1.5×ULN. Patients with measurable lesion assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline，（long diameter of primary lesion ≥1cm or minor diameter of lymph node ≥1.5cm）； Exclusion Criteria: Pregnant or lactating women were excluded. History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation). Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders. Uncontrolled infection or severe peptic ulcer need treatment. Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin. Significant abnormal EKG or cardiac disease with drastic symptoms like congestive heart failure or severe coronary disease or uncontrolled arrhythmia or myocardial infarction within 12 months or NYHA level III-IV or LVEF<55% . Be allergic to test drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DC Follow T<br>Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery. | Drug: Pegylated liposomal doxorubicin<br>* a new kind of doxorubicin<br>* Other names: PLD;Drug: Cyclophosphamide<br>* traditional chemotherapy drug<br>* Other names: C;Drug: Docetaxel<br>* traditional chemotherapy drug used in breast cancer<br>* Other names: T;|
| Active Comparator: EC Follow T<br>Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery. | Drug: Cyclophosphamide<br>* traditional chemotherapy drug<br>* Other names: C;Drug: Epirubicin<br>* traditional chemotherapy drug used in breast cancer<br>* Other names: E;Drug: Docetaxel<br>* traditional chemotherapy drug used in breast cancer<br>* Other names: T;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathological complete response rate | The pathological complete response rate of primary lesion and axillary lymph nodes | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Determine side effects of these drugs like cardiotoxicity ,hematological toxicity，gastrointestinal symptoms and so on. | 5 years | 
| Overall survival | Determine the overall survival at 5 years. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Neoadjuvant Chemotherapy, Pegylated liposomal doxorubicin, PLD