Regimens Comparison for Breast Cancers of Positive Lymph Nodes

NCT01134523 | Unknown Phase 3

• 1 other identifier: CH-BC-006
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of EC-T and ET regimen as adjuvant treatment of breast cancer patients with positive lymph nodes

Conditions

Breast Cancer

Keywords

positive lymph node

Outcome Measures

Primary Outcomes (1)

• PFS

  5 years after all the recuiment

Secondary Outcomes (2)

• OS

  5 years after all the adjuvent treatments

• Safety

  5 years after all the recruiment

Study Arms (2)

Group A: EC-T regimen

ACTIVE COMPARATOR

Drug: Epirubicin, CTX, Paclitaxel

Group B: ET regimen

EXPERIMENTAL

Drug: Epirubicin, Paclitaxel

Interventions

Epirubicin, CTX, Paclitaxel DRUG

Epirubicin 90mg/m2 and CTX 600mg/m2 on day1 of each 21-day cycle, 4 cycles; followed by Paclitaxel 175mg/m2 on day1 of each 21-day cycle, 4 cycles.

Group A: EC-T regimen

Epirubicin, Paclitaxel DRUG

Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.

Group B: ET regimen

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with breast cancer after breast cancer surgery with positive lymph nodes age 18-70 years old

You may not qualify if:

• with other malignance disease

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute & Hospital. Chinese Academy of Medical Sciences

Beijing, 100021, China

RECRUITING

Related Publications (2)

• Moebus V, Jackisch C, Lueck HJ, du Bois A, Thomssen C, Kurbacher C, Kuhn W, Nitz U, Schneeweiss A, Huober J, Harbeck N, von Minckwitz G, Runnebaum IB, Hinke A, Kreienberg R, Konecny GE, Untch M. Intense dose-dense sequential chemotherapy with epirubicin, paclitaxel, and cyclophosphamide compared with conventionally scheduled chemotherapy in high-risk primary breast cancer: mature results of an AGO phase III study. J Clin Oncol. 2010 Jun 10;28(17):2874-80. doi: 10.1200/JCO.2009.24.7643. Epub 2010 May 10.

  PMID: 20458045 BACKGROUND

• Yuan P, Kang Y, Ma F, Fan Y, Wang J, Wang X, Yue J, Luo Y, Zhang P, Li Q, Xu B. Effect of Epirubicin Plus Paclitaxel vs Epirubicin and Cyclophosphamide Followed by Paclitaxel on Disease-Free Survival Among Patients With Operable ERBB2-Negative and Lymph Node-Positive Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230122. doi: 10.1001/jamanetworkopen.2023.0122.

  PMID: 36826820 DERIVED

Related Links

• http://www.ncbi.nlm.nih.gov/pubmed/20458045

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Binghe Xu, M.D.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng Yuan, M.D.

CONTACT

86-10-8778 8114; yuanpeng01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: June 1, 2010
• First Posted: June 2, 2010
• Study Start: May 1, 2010
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2020
• Last Updated: March 15, 2013

Record last verified: 2013-03

Locations

CN (1)