Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
Completed · Phase 3
Conditions studied: HER2/Neu Positive, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
In brief
This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.
Key facts
- Study ID
- NCT00513292
- Run by
- National Cancer Institute (NCI)
- People needed
- 280
- Starts
- 2007-07-01
- Expected to finish
- 2013-02-21
- Last updated by the study team
- 2019-01-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of invasive adenocarcinoma by core needle biopsy
- Fine needle aspiration allowed provided primary tumor size < 2 cm and lymph node metastases are present
- Excisional biopsy of the primary tumor allowed provided biopsy-positive lymph nodes are present
- Primary tumor ≥ 2 cm and/or ≥ 1 biopsy-positive lymph node
- HER2-positive disease
- Confirmation by fluorescent in situ hybridization (FISH) requires gene amplification
- Confirmation by immunohistochemistry (IHC) requires a strongly positive (3+) staining intensity score
- Ductal carcinoma in situ (DCIS) or synchronous DCIS of the contralateral breast regardless of prior therapy allowed
- Synchronous invasive breast cancer not allowed
- Ipsilateral DCIS treated by local excision with or without hormonal therapy allowed
- Those treated with radiation therapy are not allowed
- No definitive clinical or radiologic evidence of metastatic disease
- No history of invasive breast cancer
- Hormone receptor status known
- Menopausal status not specified
- ECOG performance status of 0 -1
- Absolute neutrophil count ≥ 1,200/mm³
- Platelet count ≥ 100,000/mm³
- Total bilirubin normal unless the patient has a grade 1 bilirubin elevation (normal to 1.5 times upper limit of normal [ULN]) resulting from Gilbert disease or similar syndrome due to slow conjugation of bilirubin
- Alkaline phosphatase ≤ 2.5 times ULN
- AST ≤ 1.5 times ULN
- Creatinine normal
- Left ventricular ejection fraction (LVEF) ≥ 55 by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within the past 3 months
- Patients with either skeletal pain or alkaline phosphatase that is > ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease
- Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy
Where it is running
- Eden Hospital Medical Center — Castro Valley, California, United States
- Marin Cancer Care Inc — Greenbrae, California, United States
- Saint Rose Hospital — Hayward, California, United States
- Valley Care Health System - Pleasanton — Pleasanton, California, United States
- Valley Medical Oncology Consultants — Pleasanton, California, United States
- Morton Plant Hospital — Clearwater, Florida, United States
- Broward Health Medical Center — Fort Lauderdale, Florida, United States
- Lakeland Regional Cancer Center — Lakeland, Florida, United States
- Northeast Georgia Medical Center — Gainesville, Georgia, United States
- Presence Resurrection Medical Center — Chicago, Illinois, United States
- Saint Francis Hospital and Health Centers — Beech Grove, Indiana, United States
- Franciscan Saint Francis Health-Indianapolis — Indianapolis, Indiana, United States
- Reid Hospital and Health Care Services — Richmond, Indiana, United States
- Siouxland Regional Cancer Center — Sioux City, Iowa, United States
- Mercy Medical Center-Sioux City — Sioux City, Iowa, United States
- Saint Luke's Regional Medical Center — Sioux City, Iowa, United States
- Cancer Center of Kansas - Chanute — Chanute, Kansas, United States
- Cancer Center of Kansas - Dodge City — Dodge City, Kansas, United States
- Cancer Center of Kansas - El Dorado — El Dorado, Kansas, United States
- Cancer Center of Kansas - Fort Scott — Fort Scott, Kansas, United States
- Cancer Center of Kansas-Independence — Independence, Kansas, United States
- Cancer Center of Kansas-Kingman — Kingman, Kansas, United States
- Lawrence Memorial Hospital — Lawrence, Kansas, United States
- Cancer Center of Kansas-Liberal — Liberal, Kansas, United States
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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