Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00513695|
Recruitment Status : Completed
First Posted : August 9, 2007
Results First Posted : May 10, 2017
Last Update Posted : August 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Breast Cancer Male Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer||Drug: sunitinib malate Drug: paclitaxel Drug: doxorubicin hydrochloride Drug: cyclophosphamide Biological: filgrastim Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Other: flow cytometry||Phase 2|
I.To assess the microscopic pathologic complete response rate (pCR) in patients treated with a two part, neoadjuvant regimen consisting of daily oral sunitinib with weekly IV paclitaxel for 12 weeks followed by weekly doxorubicin and daily oral cyclophosphamide given with filgrastim (G-CSF) support for 15 weeks.
I. To assess the association between microscopic pCR and clinical complete response rate at the primary tumor site.
II. To assess the relapse rate, overall and disease-free survival in patients with breast cancer treated with neoadjuvant chemotherapy consisting of daily oral sunitinib with weekly IV paclitaxel for 12 weeks followed weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 15 weeks.
III. To assess the toxicity associated with these regimens. IV. To explore the relationship between planned correlative laboratory and clinical studies and indicators of efficacy such as pathologic response, clinical response and relapse.
Patients receive neoadjuvant chemotherapy comprising sunitinib malate orally (PO) once daily and paclitaxel intravenously (IV) over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim subcutaneously (SC) on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 16, 2017|
Experimental: Treatment (neoadjuvant chemotherapy before surgery)
Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
Drug: sunitinib malate
Drug: doxorubicin hydrochloride
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: flow cytometry
- Microscopic Pathologic CR (pCR) Rate [ Time Frame: At the time of surgery ]Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
- Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels [ Time Frame: At baseline, after week 12 of therapy, and prior to surgery ]
- Relapse Rate [ Time Frame: Up to two years ]Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.
- Time to Disease Progression [ Time Frame: Up to 2 years ]Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.
- Overall Survival [ Time Frame: Up to 2 years ]Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.
- Number and Percent of Subjects Reporting Adverse Events [ Time Frame: 28 days after the last dose of study drug ]See Adverse Events section for more details.
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): NCT00513695
|United States, Alaska|
|Anchorage Oncology Centre|
|Anchorage, Alaska, United States, 99508|
|Katmai Oncology Group|
|Anchorage, Alaska, United States, 99508|
|United States, Arizona|
|Arizona Cancer Center|
|Tucson, Arizona, United States, 85724-5024|
|United States, Idaho|
|Saint Luke's Mountain States Tumor Institute|
|Boise, Idaho, United States, 83712|
|United States, Washington|
|Skagit Valley Hospital|
|Mount Vernon, Washington, United States, 98273|
|Olympic Medical Center|
|Port Angeles, Washington, United States, 98362|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Jennifer Specht||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|