Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer
NCT ID: NCT02613026
Last Updated: 2015-11-24
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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COMPLETED
PHASE3
104 participants
INTERVENTIONAL
2009-07-31
2015-02-28
Brief Summary
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Detailed Description
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Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.
Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of microtubule depolymerization and leading to the formation of stable non functional microtubule bundles, which destroys mitosis of tumor cells.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combined therapy group
pirarubicin 50mg/m2, iv, d1; docetaxel 75mg/m2, div, d1. 21 days were a cycle of treatment, with a total of 4-8 cycles.
Pirarubicin
Docetaxel
Sequential therapy group
cyclophosphamide 600mg/m2, iv, d1; Pirarubicin 60mg/m2, iv, d1, 21 days were a cycle of treatment, with a total of 4 cycles. Then followed by Docetaxel 75- 100mg/m2, div, d1, 21 days were a cycle of treatment, with a total of 4 cycles.
Pirarubicin
Docetaxel
Cyclophosphamide
Interventions
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Pirarubicin
Docetaxel
Cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clearly confirmed ER, PR and HER2 statuses;
* the state of axillary lymph nodes was determined through the relevant examination steps (puncture or sentinel lymph node biopsy);
* the patients were not treated with neoadjuvant therapy and surgery.
Exclusion Criteria
* the patients who had severely abnormal organ functions or who could not tolerate chemotherapy,
* the patients with severe concomitant diseases;
* the patients with heart disease or left ventricular ejection fraction (LVEF) \<50%.
18 Years
70 Years
FEMALE
No
Sponsors
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307 Hospital of PLA
OTHER
Responsible Party
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Shikai Wu
Chief Physician,Department of Radiotherapy
Principal Investigators
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Shikai Wu
Role: PRINCIPAL_INVESTIGATOR
307 Hospital of PLA
Locations
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The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hunan Provincial People's Hospital
Changsha, Hunan, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Countries
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References
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Kaufmann M, Hortobagyi GN, Goldhirsch A, Scholl S, Makris A, Valagussa P, Blohmer JU, Eiermann W, Jackesz R, Jonat W, Lebeau A, Loibl S, Miller W, Seeber S, Semiglazov V, Smith R, Souchon R, Stearns V, Untch M, von Minckwitz G. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006 Apr 20;24(12):1940-9. doi: 10.1200/JCO.2005.02.6187.
Bear HD, Anderson S, Brown A, Smith R, Mamounas EP, Fisher B, Margolese R, Theoret H, Soran A, Wickerham DL, Wolmark N; National Surgical Adjuvant Breast and Bowel Project Protocol B-27. The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2003 Nov 15;21(22):4165-74. doi: 10.1200/JCO.2003.12.005. Epub 2003 Oct 14.
Mamounas EP, Brown A, Anderson S, Smith R, Julian T, Miller B, Bear HD, Caldwell CB, Walker AP, Mikkelson WM, Stauffer JS, Robidoux A, Theoret H, Soran A, Fisher B, Wickerham DL, Wolmark N. Sentinel node biopsy after neoadjuvant chemotherapy in breast cancer: results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2005 Apr 20;23(12):2694-702. doi: 10.1200/JCO.2005.05.188.
Other Identifiers
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AT2009
Identifier Type: -
Identifier Source: org_study_id