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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 : Active, not recruiting
First Posted : August 9, 2007
Results First Posted : May 10, 2017
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jennifer Specht, University of Washington

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Inflammatory Breast Cancer
Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions Drug: sunitinib malate
Drug: paclitaxel
Drug: doxorubicin hydrochloride
Drug: cyclophosphamide
Biological: filgrastim
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: flow cytometry
Enrollment 68
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Period Title: Overall Study
Started 68
Completed 63
Not Completed 5
Reason Not Completed
Discontinued therapy             2
Progression prior to surgery             3
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Baseline Participants 68
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants
50
(33 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Female
68
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
Hispanic or Latino
4
   5.9%
Not Hispanic or Latino
56
  82.4%
Unknown or Not Reported
8
  11.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants
American Indian or Alaska Native
0
   0.0%
Asian
4
   5.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   2.9%
White
50
  73.5%
More than one race
4
   5.9%
Unknown or Not Reported
8
  11.8%
1.Primary Outcome
Title Microscopic Pathologic CR (pCR) Rate
Hide Description 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.
Time Frame At the time of surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of evaluable participants
27
(18 to 39)
2.Secondary Outcome
Title Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels
Hide Description [Not Specified]
Time Frame At baseline, after week 12 of therapy, and prior to surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Relapse Rate
Hide Description Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.
Time Frame Up to two years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: probability of relapse
0.215
(0.125 to 0.322)
4.Secondary Outcome
Title Time to Disease Progression
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 63
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
[1]
Not reached because not enough progression events.
5.Secondary Outcome
Title Overall Survival
Hide Description 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.
Time Frame Up to 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: survival probability
0.875
(0.798 to 0.960)
6.Secondary Outcome
Title Number and Percent of Subjects Reporting Adverse Events
Hide Description See Adverse Events section for more details.
Time Frame 28 days after the last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description:

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

Overall Number of Participants Analyzed 68
Measure Type: Count of Participants
Unit of Measure: Participants
67
  98.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Neoadjuvant Chemotherapy Before Surgery)
Hide Arm/Group Description

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.

sunitinib malate: Given PO

paclitaxel: Given IV

doxorubicin hydrochloride: Given IV

cyclophosphamide: Given PO

filgrastim: Given SC

therapeutic conventional surgery: Undergo surgery

laboratory biomarker analysis: Correlative studies

flow cytometry: Correlative studies

All-Cause Mortality
Treatment (Neoadjuvant Chemotherapy Before Surgery)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Neoadjuvant Chemotherapy Before Surgery)
Affected / at Risk (%)
Total   47/68 (69.12%) 
Blood and lymphatic system disorders   
Neutropenia (ANC)  47/68 (69.12%) 
Leucopenia  23/68 (33.82%) 
Anemia  15/68 (22.06%) 
Gastrointestinal disorders   
Diarrhea  3/68 (4.41%) 
Nausea  1/68 (1.47%) 
General disorders   
Fatigue  3/68 (4.41%) 
Pain  2/68 (2.94%) 
Investigations   
ALT elevation  4/68 (5.88%) 
Nervous system disorders   
Sensory Neuropathy  3/68 (4.41%) 
Respiratory, thoracic and mediastinal disorders   
Mucositis  7/68 (10.29%) 
Skin and subcutaneous tissue disorders   
Rash  1/68 (1.47%) 
Nail changes  2/68 (2.94%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment (Neoadjuvant Chemotherapy Before Surgery)
Affected / at Risk (%)
Total   67/68 (98.53%) 
Blood and lymphatic system disorders   
Neutropenia (ANC)  22/68 (32.35%) 
Leucopenia  34/68 (50.00%) 
Anemia  32/68 (47.06%) 
Gastrointestinal disorders   
Diarrhea  9/68 (13.24%) 
Heartburn  8/68 (11.76%) 
Nausea  8/68 (11.76%) 
General disorders   
Fatigue  37/68 (54.41%) 
Pain  15/68 (22.06%) 
Investigations   
ALT elevation  6/68 (8.82%) 
Nervous system disorders   
Sensory Neuropathy  4/68 (5.88%) 
Psychiatric disorders   
Mood alteration  7/68 (10.29%) 
Respiratory, thoracic and mediastinal disorders   
Mucositis  5/68 (7.35%) 
Skin and subcutaneous tissue disorders   
Rash  8/68 (11.76%) 
Nail changes  12/68 (17.65%) 
Vascular disorders   
Hypertension  8/68 (11.76%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Jennifer Specht, MD
Organization: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Phone: (206) 288-6889
Responsible Party: Jennifer Specht, University of Washington
ClinicalTrials.gov Identifier: NCT00513695     History of Changes
Obsolete Identifiers: NCT00831584
Other Study ID Numbers: 6488
NCI-2010-00607 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: August 8, 2007
First Posted: August 9, 2007
Results First Submitted: March 24, 2017
Results First Posted: May 10, 2017
Last Update Posted: August 21, 2018