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Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

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ClinicalTrials.gov Identifier: NCT01732939
Recruitment Status : Unknown
Verified February 2014 by Hospital Affiliated to Military Medical Science, Beijing.
Recruitment status was:  Recruiting
First Posted : November 26, 2012
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The study purpose is to observe which neoadjuvant chemotherapy regimens is the better for invasive breast cancer. The neoadjuvant chemotherapy regimen is sustained anthracyclines plus taxanes or from anthracyclines plus taxanes to vinorelbine plus cisplatinum.

Condition or disease Phase
Breast Cancer Phase 2

Detailed Description:
The investigators hope to get preliminary results for the breast cancer patients who are given different neoadjuvant chemothetapy regimens. The patients are randomized two chemotherapy regimens. One is anthracyclines plus taxanes for 6-8 cycles,the other is anthracyclines plus taxanes for 3-4 cycles ,then switch tovinorelbine plus cisplatinum for 3-4 cycles.

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : May 2012
Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
AT
Docetaxel 75 mg/m2, day 1 or paclitaxel 175mg/m2 day 1 plus Epirubicin 75 mg/m2, day 1 or doxorubicine 50mg/m2 day 1 for 6-8 cycles
AT-NP
docetaxel 75mg/m2,day 1 or paclitaxel 175mg/m2,day 1 plus doxorubicine 50mg/m2,day 1 or epirubicin 75mg/m2, day 1,for3-4 cycles then switch to vinorelbine 25mg/m2, day 1 and day 8 plus cisplatinum 75mg/m2, day 1 for 3-4 cycles


Outcome Measures

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

Secondary Outcome Measures :
  1. clinical response rate, safety [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
diaganosis of invasive breast cancer, tumor size > 2.0cm by MRI or ultrasound or clinical examination.
Criteria

Inclusion Criteria:

  • Diagnosis of invasive ductal or lobular breast cancer.
  • Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
  • no anti-Her2 therapy if HER2 positive ( defined as 3+ IHC or FISH positive)
  • Performance Status ECOG <2
  • Age > 18 years
  • Tumor > 2.0 cm by MRI and/or sonographic or clinical exam measurements.or Karnofsky >50%
  • Lab test :

    • Absolute neutrophil count > 1,500/mm3

      • Total Bilirubin ≤ 2×ULN
      • AST and ALT ≤ 2.5×ULN
    • serum creatinine ≤ 1.5×ULN

Exclusion Criteria:

  • Pregnant or breast feeding patients are excluded
  • stage Ⅳ breast cancer
  • History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon,melanoma in situ, and basal cell and squamous cell carcinomas of the skin
  • uncontrolled cardiac disease
  • Active infection or chronic infection requiring chronic suppressive antibiotics
  • History of hypersensitivity reaction to investigating drugs
Contacts and Locations

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): NCT01732939


Locations
China, Beijing
Hospital affiliated academy military medical science Recruiting
Beijing, Beijing, China, 100071
Contact: Tao Wang, MD    8610-66947430      
Contact: Shaohua ZHANG, MD    8610-66947173      
Principal Investigator: Zefei Jiang, MD         
Sponsors and Collaborators
Hospital Affiliated to Military Medical Science, Beijing
Investigators
Principal Investigator: Zefei Jiang, MD Hospital Affiliated Military Medical Science
More Information

Responsible Party: Hospital Affiliated to Military Medical Science, Beijing
ClinicalTrials.gov Identifier: NCT01732939     History of Changes
Other Study ID Numbers: 307BCNeo-01
First Posted: November 26, 2012    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases