Efficacy and Safety of Neoadjuvant DC-T in Breast Cancer Patients
NCT ID: NCT03123770
Last Updated: 2019-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
384 participants
INTERVENTIONAL
2016-12-31
2021-12-31
Brief Summary
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Detailed Description
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Participants are randomized to 1 of 2 treatment arms.
1. Arm I: Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
2. 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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DC Follow T
Participants receive pegylated liposomal doxorubicin plus cyclophosphamide followed by docetaxel before surgery.
Pegylated liposomal doxorubicin
a new kind of doxorubicin
Cyclophosphamide
traditional chemotherapy drug
Docetaxel
traditional chemotherapy drug used in breast cancer
EC Follow T
Participants receive epirubicin plus cyclophosphamide followed by docetaxel before surgery.
Cyclophosphamide
traditional chemotherapy drug
Epirubicin
traditional chemotherapy drug used in breast cancer
Docetaxel
traditional chemotherapy drug used in breast cancer
Interventions
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Pegylated liposomal doxorubicin
a new kind of doxorubicin
Cyclophosphamide
traditional chemotherapy drug
Epirubicin
traditional chemotherapy drug used in breast cancer
Docetaxel
traditional chemotherapy drug used in breast cancer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. WHO (ECOG) performance status 0-2.
3. Patients who have read and understand the informed consent form and have given written informed consent.
4. Diagnosed as invasive breast cancer by core biopsy
5. Diagnosed pre-surgically as (cTNM Staging)Stage II-III and suit for neoadjuvant chemotherapy.
6. Patients had previously not received chemotherapy，radiotherapy or biotherapy.
7. 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.
8. 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
2. History of receiving organ transplantation（including Autologous bone marrow transplantation and peripheral hematopoietic stem-cell transplantation).
3. Dysfunction of peripheral nerve system caused by other diseases or history of either severe mental disorder or central nervous system disorders.
4. Uncontrolled infection or severe peptic ulcer need treatment.
5. Severe hepatic disease（such as hepatic cirrhosis),nephrosis,respiratory disease or uncontrolled diabetes.
6. 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.
7. 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% .
8. Be allergic to test drugs.
18 Years
70 Years
FEMALE
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
First Affiliated Hospital of Zhejiang University
OTHER
Sir Run Run Shaw Hospital
OTHER
Women's Hospital School Of Medicine Zhejiang University
OTHER
Zhejiang Cancer Hospital
OTHER
Zhejiang Provincial People's Hospital
OTHER
Zhejiang Provincial Hospital of TCM
OTHER
First People's Hospital of Hangzhou
OTHER
Hangzhou Hospital of Traditional Chinese Medicine
OTHER
First Affiliated Hospital of Wenzhou Medical University
OTHER
Ningbo No. 1 Hospital
OTHER
Jinhua Central Hospital
OTHER
Zhejiang University
OTHER
Responsible Party
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Zhigang Zhang
Dr
Principal Investigators
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Huang Jian, Dr
Role: STUDY_CHAIR
Second Affiliated Hospital of Zhejiang University School of Medicine
Locations
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Cancer institute
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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O'Brien ME, Wigler N, Inbar M, Rosso R, Grischke E, Santoro A, Catane R, Kieback DG, Tomczak P, Ackland SP, Orlandi F, Mellars L, Alland L, Tendler C; CAELYX Breast Cancer Study Group. Reduced cardiotoxicity and comparable efficacy in a phase III trial of pegylated liposomal doxorubicin HCl (CAELYX/Doxil) versus conventional doxorubicin for first-line treatment of metastatic breast cancer. Ann Oncol. 2004 Mar;15(3):440-9. doi: 10.1093/annonc/mdh097.
Vici P, Pizzuti L, Gamucci T, Sergi D, Conti F, Zampa G, Del Medico P, De Vita R, Pozzi M, Botti C, Di Filippo S, Tomao F, Sperduti I, Di Lauro L. Non-pegylated liposomal Doxorubicin-cyclophosphamide in sequential regimens with taxanes as neoadjuvant chemotherapy in breast cancer patients. J Cancer. 2014 Apr 25;5(6):398-405. doi: 10.7150/jca.9132. eCollection 2014.
Gil-Gil MJ, Bellet M, Morales S, Ojeda B, Manso L, Mesia C, Garcia-Martinez E, Martinez-Janez N, Mele M, Llombart A, Pernas S, Villagrasa P, Blasco C, Baselga J. Pegylated liposomal doxorubicin plus cyclophosphamide followed by paclitaxel as primary chemotherapy in elderly or cardiotoxicity-prone patients with high-risk breast cancer: results of the phase II CAPRICE study. Breast Cancer Res Treat. 2015 Jun;151(3):597-606. doi: 10.1007/s10549-015-3415-2. Epub 2015 May 16.
Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, Pascual-Martinez O, Abad-Sazatornil MR, Agustin-Ferrandez MJ. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer. Int J Clin Pharm. 2016 Apr;38(2):446-53. doi: 10.1007/s11096-016-0278-5. Epub 2016 Mar 7.
Other Identifiers
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ESNDBCP
Identifier Type: -
Identifier Source: org_study_id
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