Marched Pair Study Conventional Doxorubicin(DOX) Versus Pegylated Liposomal Doxorubicin(PLD) Neoadjuvant Chemotherapy
NCT ID: NCT02953184
Last Updated: 2017-12-29
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
PHASE2
160 participants
INTERVENTIONAL
2016-11-30
2020-11-30
Brief Summary
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Detailed Description
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PLD 35mg/m2 in combination with paclitaxel showed an overall response rate of 71% ,tolerating toxicity of the skin(3% hand-foot syndrome)and rare cardiac event( H. Gogas1, Annals of Oncology, 2002;Gil-Gil , Breast Cancer Res Treat. 2015)However, There are a crucial question is to know if 35mg/m2 PLD has equivalent efficacy with less cardiac toxicity compared with 60 mg/m2 DOX in adjuvant chemotherapy for all patients.
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 NCCN guideline).
Condition Intervention Phase
Individualized Chemotherapy Drug: Pegylated Liposomal Doxorubicin(PLD) Drug: Doxorubicin(DOX)
Drug: Cyclophosphamide Drug: docetaxel or Paclitaxel Phase 2
Study Type: Interventional Study Design: Allocation: assignment based on patients desire Endpoint Classification: Safety/Efficacy Study Intervention Model: Marched pair Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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conventional Doxorubicin plus C-T
AC-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
Cyclophosphamide
600mg/m2 IV drop during the first 4 cycles every three week
Taxotere
100mg/m2 IV drop during the last 4 cycles every three week
Dexrazoxane (DZR)
DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.
Doxorubicin
60mg/m2 Doxorubicin IV drop during the first 4 cycles every three week
Breast Conserved Surgery
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
Modified Radical Mastectomy
Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy
Sentinel Lymph Node Biopsy（SLNB）
Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy
PLD plus C -T
Pegylated 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
Pegylated Liposomal Doxorubicin
35mg/m2 iv drop during the first 4 cycles every three week
Cyclophosphamide
600mg/m2 IV drop during the first 4 cycles every three week
Taxotere
100mg/m2 IV drop during the last 4 cycles every three week
vitamin B
Vitamin B will be administrated for protecting HFS in PLD group
Breast Conserved Surgery
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
Modified Radical Mastectomy
Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy
Sentinel Lymph Node Biopsy（SLNB）
Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy
Interventions
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Pegylated Liposomal Doxorubicin
35mg/m2 iv drop during the first 4 cycles every three week
Cyclophosphamide
600mg/m2 IV drop during the first 4 cycles every three week
Taxotere
100mg/m2 IV drop during the last 4 cycles every three week
Dexrazoxane (DZR)
DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.
vitamin B
Vitamin B will be administrated for protecting HFS in PLD group
Doxorubicin
60mg/m2 Doxorubicin IV drop during the first 4 cycles every three week
Breast Conserved Surgery
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
Modified Radical Mastectomy
Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy
Sentinel Lymph Node Biopsy（SLNB）
Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Jilin University
OTHER
Responsible Party
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Aiping shi
Professor
Principal Investigators
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Aiping Shi, Doctor
Role: PRINCIPAL_INVESTIGATOR
The First Hospital of Jilin University
Locations
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First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Facility Contacts
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Aiping Shi, Doctor
Role: primary
Zhimin Fan, Doctor
Role: backup
References
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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.
Lotrionte 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.
Jones 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.
Gogas 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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2016yx238
Identifier Type: -
Identifier Source: org_study_id