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Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

This study is currently recruiting participants.
Verified November 2012 by Hospital Affiliated to Military Medical Science, Beijing
Sponsor:
Information provided by (Responsible Party):
Hospital Affiliated to Military Medical Science, Beijing
ClinicalTrials.gov Identifier:
NCT01732939
First received: October 10, 2012
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Phase
Breast Cancer
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Affiliated to Military Medical Science, Beijing:

Primary Outcome Measures:
  • pathological complete response rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical response rate, safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hospital Affiliated to Military Medical Science, Beijing
ClinicalTrials.gov Identifier: NCT01732939     History of Changes
Other Study ID Numbers: 307BCNeo-01
Study First Received: October 10, 2012
Last Updated: November 23, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 18, 2013