Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

• Conditions: Breast Cancer

• Registration Number: NCT01732939
• Lead Sponsor: Hospital Affiliated to Military Medical Science, Beijing

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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-11-23
• Study First Posted: 2012-11-26
• Primary Completion: 2013-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-17
• Last Update Posted: 2014-02-19
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pathological complete response rate	one year

Secondary Outcome Measures

Name	Time	Method
clinical response rate, safety	one year

Trial Locations

Locations (1)

Hospital affiliated academy military medical science; 🇨🇳 Beijing, Beijing, China