Combination Chemotherapy and Bevacizumab in Treating Women With HER2/Neu-Negative Stage II or Stage III Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00679029|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2008
Last Update Posted : January 25, 2018
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and gemcitabine hydrochloride, 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 bevacizumab, 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. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well giving combination chemotherapy together with bevacizumab works in treating women with HER2/neu-negative stage II or stage III breast cancer
|Condition or disease||Intervention/treatment||Phase|
|HER2-negative Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer||Drug: doxorubicin hydrochloride Drug: cyclophosphamide Biological: bevacizumab Drug: paclitaxel Drug: gemcitabine hydrochloride Other: laboratory biomarker analysis Biological: pegfilgrastim||Phase 2|
I. To assess the feasibility of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting.
II. To assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation.
I. To determine the effect of Avastin on immunity, especially VEGF-A upregulation of MDSC and suppression of T-Cells.
II. To determine the effect of therapy on numbers of myeloid derived suppressor cells and compare the humoral and cellular response to p53 in breast cancer patients treated with the same chemotherapy.
III. Patients will be followed for freedom from tumor progression and survival.
COURSES 1-4: Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 1. Treatment repeats every 2 weeks for 4 courses in the absence of unacceptable toxicity or disease progression.
COURSES 5-7: Patients receive paclitaxel IV and gemcitabine hydrochloride IV on day 1 and pegfilgrastim SC on day 1. Patients also receive bevacizumab IV on day 1 in courses 5-7. Treatment repeats every 2 weeks for 4 courses in the absence of unacceptable toxicity or disease progression.
COURSES 8-16: Patients receive bevacizumab IV alone on day 1. Treatment repeats every 3 weeks for 8 courses in the absence of unacceptable toxicity or disease progression.
After course 8, patients may undergo radiotherapy and hormone therapy, if clinically indicated.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Adjuvant Doxorubicin, Cyclophosphamide Followed by Avastin Given With Paclitaxel and Gemcitabine for Stage II and III Breast Cancer That Does Not Over-express HER-2/Neu|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: Arm I
See Detailed Description
Drug: doxorubicin hydrochloride
Drug: gemcitabine hydrochloride
Other: laboratory biomarker analysis
- Feasibility as assessed by the proportion of patients with study drug-associated adverse events leading to dose holds or reductions summarized using percentages and 95% confidence intervals [ Time Frame: At study drug-associated adverse events leading to dose holds or reductions ]
- Toxicity as assessed by NCI Common Toxicity Criteria v3.0 [ Time Frame: At the worsening of a concurrent disease or the development of a new concurrent disease ]
- Disease-free survival as assessed by the Kaplan and Meier method [ Time Frame: From the date of first treatment to the date of disease progression/recurrence, second cancer, or death ]
- Overall survival as assessed by the Kaplan and Meier method [ Time Frame: From the date of first treatment to the date of death ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00679029
|United States, Nebraska|
|UNMC Eppley Cancer Center at the University of Nebraska Medical Center|
|Omaha, Nebraska, United States, 68198-6805|
|Principal Investigator:||Elizabeth Reed||University of Nebraska|