Phase II Study of Neoadjuvant Chemotherapy Regimen Choice in Breast Cancer
Conditions
Breast Cancer
Study Type
Observational
Study Phase
Phase 2
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Hospital affiliated academy military medical science
Beijing, Beijing, China
Status: Recruiting
Contact: Tao Wang, MD - 8610-66947430
Start Date
May 2012
Completion Date
May 2014
Sponsors
Hospital Affiliated to Military Medical Science, Beijing
Source
Hospital Affiliated to Military Medical Science, Beijing
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page