Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy
Marched Pair Study of the Standard Chemotherapy 4doxorubicin Plus Cyclophosphamide(AC) 60 + 4 Docetaxel Protocol Versus 4 PLD C35+4 Docetaxel in Neoadjuvant Chemotherapy of Breast Cancer
1 other identifier
interventional
160
1 country
1
Brief Summary
The regimen PLD plus cyclophosphamide 4 cycles followed by paclitaxel or docetaxel 4 cycles(noted in phase II CAPRICE) will be used as experimental group. The regimen will be compared to the standard treatment of doxorubicin plus cyclophosphamide(AC) 4 cycles followed by paclitaxel or docetaxel 4 cycles\[noted in National Comprehensive Cancer Network (NCCN) guideline\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedDecember 29, 2017
December 1, 2017
3 years
October 8, 2016
December 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
improvement of pathological complete response（PCR)
Pathological evaluation after sugary
at th 26th weeks of treatment since recruitment (after 8 cycles of neoadjuvant chemotherapy when the patient will undergo surgery)
Secondary Outcomes (2)
Tolerance according to Common Terminology Criteria Adverse Events (CTCAE) Version 4.0
at 3rd ,6th,9th,12th, 15 ,18,21,24th weeks since recruitment (after each cycle of chemotherapy) ; half year ,1 year , one and half year ,two years since recruitment
Clinical Response Rate
at 3rd ,6th,9th,12th, 15 ,18,21,24th weeks since recruitment （after each cycle of chemotherapy）
Study Arms (2)
conventional Doxorubicin plus C-T
ACTIVE COMPARATORAC-T regimen 8 cycles ,60mg/M2 conventional Doxorubicin will be used as active comparator. four cycles of Doxorubicin plus 600mg/m2 Cyclophosphamide every three weeks followed 4 cycles of 100mg/m2 Taxotere, every three weeks for one cycle.Dexrazoxane (DZR)will be used for protecting cardiac toxicity.Patients will undergo Modified Radical Mastectomy or Breast Conserved Surgery or Axillary Lymph Node Dissection(ALND) or Sentinel Lymph Node Biopsy（SLNB） after 8 cycles of chemotherapy
PLD plus C -T
EXPERIMENTALPegylated Liposomal Doxorubicin(PLD) plus Cyclophosphamide followed Taxotere 8 cycles.35mg/M2 PLD will be used as experimental medicine. four cycles of PLD plus 600mg/m2 Cyclophosphamide every three weeks followed 4 cycles of 100mg/m2 Taxotere , every three weeks for one cycle.Vitamin B will be used for protecting hand-foot syndrome(HFS).Patients will undergo Modified Radical Mastectomy or Breast Conserved Surgery or Axillary Lymph Node Dissection(ALND) or Sentinel Lymph Node Biopsy（SLNB） after 8 cycles of chemotherapy
Interventions
35mg/m2 iv drop during the first 4 cycles every three week
600mg/m2 IV drop during the first 4 cycles every three week
100mg/m2 IV drop during the last 4 cycles every three week
DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.
Vitamin B will be administrated for protecting HFS in PLD group
60mg/m2 Doxorubicin IV drop during the first 4 cycles every three week
Patients will undergo Breast Conserved Surgery if the tumor/breast ratio is proper and she demands to conserve the breast after 8 cycles of chemotherapy
Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy
Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy
Eligibility Criteria
You may qualify if:
- Patient with histological proof of invasive cancer, whose clinical tumor diameter is \> 2 cm, or \< 2 cm, but Axillary lymphnodes are involved .There is no metastatic Imaging findings.
- Stage II,III tumor, non-metastatic, grade II - III
- Performance Status = 0-1 World Health Organization (WHO).
- Patient non pretreated for breast cancer.
- Patient without cardiac pathology and without anthracyclines contra-indication (assessed by normal ejection fraction).
- Normal haematological, renal and hepatic functions : platelets \> 100. 109 /l, Hb \> 10 g/dl, normal bilirubin serum , Aspartate transaminase(ASAT) and Alanine Aminotransferase(ALAT) \< 2,5 Upper Limit of Normal (ULN), alkaline phosphatases \< 2,5 ULN, creatinin \< 140 µmol/l or creatinin clearance \> 60 ml/min
- Written informed consent dated and signed by the patient
You may not qualify if:
- Patient presenting with intraduct cancer in situ.(DCIS)
- Grade I well differentiated tumor.
- Non measurable lesion, in the two diameters, whatever radiological methods used.
- Patient already operated for breast cancer or having had primary axillar node dissection.
- Patient presenting with cancer in other system.
- Any psychological, familial, sociological or geographical condition that may potentially hamper compliance with the study protocol and follow up schedule, assessed with the patient prior to registration in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jilin Universitylead
Study Sites (1)
First Hospital of Jilin University
Changchun, Jilin, 130021, China
Related Publications (6)
Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M, Cutter D, Darby S, McGale P, Taylor C, Wang YC, Bergh J, Di Leo A, Albain K, Swain S, Piccart M, Pritchard K. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012 Feb 4;379(9814):432-44. doi: 10.1016/S0140-6736(11)61625-5. Epub 2011 Dec 5.
PMID: 22152853BACKGROUNDLotrionte M, Biondi-Zoccai G, Abbate A, Lanzetta G, D'Ascenzo F, Malavasi V, Peruzzi M, Frati G, Palazzoni G. Review and meta-analysis of incidence and clinical predictors of anthracycline cardiotoxicity. Am J Cardiol. 2013 Dec 15;112(12):1980-4. doi: 10.1016/j.amjcard.2013.08.026. Epub 2013 Sep 25.
PMID: 24075281BACKGROUNDJones S, Holmes FA, O'Shaughnessy J, Blum JL, Vukelja SJ, McIntyre KJ, Pippen JE, Bordelon JH, Kirby RL, Sandbach J, Hyman WJ, Richards DA, Mennel RG, Boehm KA, Meyer WG, Asmar L, Mackey D, Riedel S, Muss H, Savin MA. Docetaxel With Cyclophosphamide Is Associated With an Overall Survival Benefit Compared With Doxorubicin and Cyclophosphamide: 7-Year Follow-Up of US Oncology Research Trial 9735. J Clin Oncol. 2009 Mar 10;27(8):1177-83. doi: 10.1200/JCO.2008.18.4028. Epub 2009 Feb 9.
PMID: 19204201BACKGROUNDGogas H, Papadimitriou C, Kalofonos HP, Bafaloukos D, Fountzilas G, Tsavdaridis D, Anagnostopoulos A, Onyenadum A, Papakostas P, Economopoulos T, Christodoulou C, Kosmidis P, Markopoulos C. Neoadjuvant chemotherapy with a combination of pegylated liposomal doxorubicin (Caelyx) and paclitaxel in locally advanced breast cancer: a phase II study by the Hellenic Cooperative Oncology Group. Ann Oncol. 2002 Nov;13(11):1737-42. doi: 10.1093/annonc/mdf284.
PMID: 12419745BACKGROUNDGil-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.
PMID: 25981896BACKGROUNDO'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.
PMID: 14998846BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aiping Shi, Doctor
The First Hospital of Jilin University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 8, 2016
First Posted
November 2, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2019
Study Completion
November 1, 2020
Last Updated
December 29, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Jan 1,2018 to Dec ,31,2020