Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating P… (NCT00436566) | Clinical Trial Compass
CompletedPhase 2
Doxorubicin and Cyclophosphamide Followed By Trastuzumab, Paclitaxel, and Lapatinib in Treating Patients With Early-Stage HER2-Positive Breast Cancer That Has Been Removed By Surgery
United States122 participantsStarted 2007-03-16
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with trastuzumab and lapatinib after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This randomized phase II trial is studying the side effects and how well giving doxorubicin together with cyclophosphamide followed by trastuzumab, paclitaxel, and lapatinib works in treating patients with early-stage HER2-positive breast cancer that has been removed by surgery.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of early-stage breast cancer
* HER2 positive by immunohistochemistry (IHC) (3+) or fluorescent in situ hybridization (FISH)
* Ductal carcinoma in situ (DCIS) components should not be counted in the determination of degree of IHC staining or FISH amplification
* No locally advanced tumors (i.e., T4) at diagnosis, including the following:
* Tumors fixed to chest wall
* Peau d'orange
* Skin ulcerations or nodules
* Clinical inflammatory changes (e.g., diffuse brawny cutaneous induration with an erysipeloid edge)
* Has undergone mastectomy or lumpectomy with axillary node or sentinel node dissection within the past 84 days
* Patients who have undergone a mastectomy must meet the following criteria:
* No evidence of gross or microscopic tumor (i.e., invasive DCIS) at the surgical resection margins noted in final surgery or pathology reports
* Patients with close margins are eligible
* Radiation therapy is required for 4 or more positive lymph nodes and must be started after completion of chemotherapy
* Patients who have undergone a lumpectomy with axillary node or sentinel node dissection must meet the following criteria:
* No evidence of invasive cancer or DCIS at the surgical resection margins
* No gross residual adenopathy
* Planning to undergo radiation therapy to the breast with or without regional lymphatics after completion of chemotherapy
* No active hepatic or…
What they're measuring
1
Number of Patients With Congestive Heart Failure (CHF) While on Active Treatment