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Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer

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ClinicalTrials.gov Identifier: NCT02613026
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : November 24, 2015
Sponsor:
Information provided by (Responsible Party):
Shikai Wu, 307 Hospital of PLA

Brief Summary:
The purpose of this study is to compare the short-term and long-term efficacies and the safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Pirarubicin Drug: Docetaxel Drug: Cyclophosphamide Phase 3

Detailed Description:

Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial, anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of breast cancer.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Analysis of the Efficacies of AT and AC-T Regimens in Neoadjuvant Chemotherapy of Breast Cancer
Study Start Date : July 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Drug: Pirarubicin
Other Name: Tetrahydropyranyl Adriamycin
Drug: Docetaxel
Other Name: Taxotere
Experimental: 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.
Drug: Pirarubicin
Other Name: Tetrahydropyranyl Adriamycin
Drug: Docetaxel
Other Name: Taxotere
Drug: Cyclophosphamide



Primary Outcome Measures :
  1. pathological complete response rate [ Time Frame: one year ]

Secondary Outcome Measures :
  1. clinical response rate [ Time Frame: one year ]
  2. Percentage of changes in hormone receptors status after treatment [ Time Frame: one year ]
  3. Number of relative prognostic factors which influence pCR [ Time Frame: three years ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histopathologically diagnosed with stage I-III breast cancers;
  • 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 whose breasts or axillary lumps had received excision biopsy;

    • 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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613026


Locations
China, Hebei
The fourth hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050010
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
China, Hunan
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
Xiangya Hospital, Central South University
Changsha, Hunan, China, 410008
China, Jiangsu
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
307 Hospital of PLA
Investigators
Principal Investigator: Shikai Wu 307 Hospital of PLA

Publications:
Responsible Party: Shikai Wu, Chief Physician,Department of Radiotherapy, 307 Hospital of PLA
ClinicalTrials.gov Identifier: NCT02613026     History of Changes
Other Study ID Numbers: AT2009
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015

Keywords provided by Shikai Wu, 307 Hospital of PLA:
Breast tumor
Neoadjuvant chemotherapy
Pathological complete remission

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Pirarubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators