Trial Outcomes & Findings for Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer (NCT NCT00513695)
NCT ID: NCT00513695
Last Updated: 2019-08-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
At the time of surgery
Results posted on
2019-08-07
Participant Flow
Participant milestones
| Measure |
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.
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 Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
63
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
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 Study
Discontinued therapy
|
2
|
|
Overall Study
Progression prior to surgery
|
3
|
Baseline Characteristics
Sunitinib Malate, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide Before Surgery in Treating Patients With Stage IIB-IIIC Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=68 Participants
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
|
|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of surgeryDefined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
Outcome measures
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=63 Participants
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
|
|---|---|
|
Microscopic Pathologic CR (pCR) Rate
|
27 percent of evaluable participants
Interval 18.0 to 39.0
|
SECONDARY outcome
Timeframe: At baseline, after week 12 of therapy, and prior to surgeryPopulation: Data not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to two yearsCumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.
Outcome measures
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=63 Participants
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
|
|---|---|
|
Relapse Rate
|
0.215 probability of relapse
Interval 0.125 to 0.322
|
SECONDARY outcome
Timeframe: Up to 2 yearsMedian time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.
Outcome measures
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=63 Participants
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
|
|---|---|
|
Time to Disease Progression
|
NA days
Not reached because not enough progression events.
|
SECONDARY outcome
Timeframe: Up to 2 yearsKaplan-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.
Outcome measures
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=63 Participants
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 Survival
|
0.875 survival probability
Interval 0.798 to 0.96
|
SECONDARY outcome
Timeframe: 28 days after the last dose of study drugSee Adverse Events section for more details.
Outcome measures
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=68 Participants
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
|
|---|---|
|
Number and Percent of Subjects Reporting Adverse Events
|
67 Participants
|
Adverse Events
Treatment (Neoadjuvant Chemotherapy Before Surgery)
Serious events: 47 serious events
Other events: 67 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=68 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia (ANC)
|
69.1%
47/68
|
|
Blood and lymphatic system disorders
Leucopenia
|
33.8%
23/68
|
|
General disorders
Fatigue
|
4.4%
3/68
|
|
Blood and lymphatic system disorders
Anemia
|
22.1%
15/68
|
|
Gastrointestinal disorders
Diarrhea
|
4.4%
3/68
|
|
Investigations
ALT elevation
|
5.9%
4/68
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/68
|
|
General disorders
Pain
|
2.9%
2/68
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
2.9%
2/68
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
10.3%
7/68
|
|
Gastrointestinal disorders
Nausea
|
1.5%
1/68
|
|
Nervous system disorders
Sensory Neuropathy
|
4.4%
3/68
|
Other adverse events
| Measure |
Treatment (Neoadjuvant Chemotherapy Before Surgery)
n=68 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia (ANC)
|
32.4%
22/68
|
|
Blood and lymphatic system disorders
Leucopenia
|
50.0%
34/68
|
|
General disorders
Fatigue
|
54.4%
37/68
|
|
Blood and lymphatic system disorders
Anemia
|
47.1%
32/68
|
|
Gastrointestinal disorders
Diarrhea
|
13.2%
9/68
|
|
Investigations
ALT elevation
|
8.8%
6/68
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.8%
8/68
|
|
General disorders
Pain
|
22.1%
15/68
|
|
Vascular disorders
Hypertension
|
11.8%
8/68
|
|
Gastrointestinal disorders
Heartburn
|
11.8%
8/68
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
17.6%
12/68
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
7.4%
5/68
|
|
Gastrointestinal disorders
Nausea
|
11.8%
8/68
|
|
Psychiatric disorders
Mood alteration
|
10.3%
7/68
|
|
Nervous system disorders
Sensory Neuropathy
|
5.9%
4/68
|
Additional Information
Jennifer Specht, MD
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Phone: (206) 288-6889
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place