Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer

Hospital Affiliated to Military Medical Science, Beijing1 site in 1 country60 target enrollmentMay 2012

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Hospital Affiliated to Military Medical Science, Beijing
Enrollment: 60
Locations: 1
Primary Endpoint: pathological complete response rate
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

May 2014

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Hospital Affiliated to Military Medical Science, Beijing

Responsible Party

Sponsor

Eligibility 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

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