Trial Outcomes & Findings for Treatment With Pazopanib for Neoadjuvant Breast Cancer (NCT NCT00849472)
NCT ID: NCT00849472
Last Updated: 2014-03-04
Results Overview
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)
Results posted on
2014-03-04
Participant Flow
Participant milestones
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Doxorubicin and Cyclophosphamide (AC)
STARTED
|
101
|
|
Doxorubicin and Cyclophosphamide (AC)
COMPLETED
|
95
|
|
Doxorubicin and Cyclophosphamide (AC)
NOT COMPLETED
|
6
|
|
Weekly Paclitaxel
STARTED
|
94
|
|
Weekly Paclitaxel
COMPLETED
|
78
|
|
Weekly Paclitaxel
NOT COMPLETED
|
16
|
|
Pazopanib Presurgery Treatment (PPT)
STARTED
|
94
|
|
Pazopanib Presurgery Treatment (PPT)
COMPLETED
|
36
|
|
Pazopanib Presurgery Treatment (PPT)
NOT COMPLETED
|
58
|
|
Pazopanib Postsurgery Treatment
STARTED
|
42
|
|
Pazopanib Postsurgery Treatment
COMPLETED
|
16
|
|
Pazopanib Postsurgery Treatment
NOT COMPLETED
|
26
|
Reasons for withdrawal
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Doxorubicin and Cyclophosphamide (AC)
Disease Progression
|
2
|
|
Doxorubicin and Cyclophosphamide (AC)
Adverse Event
|
1
|
|
Doxorubicin and Cyclophosphamide (AC)
Withdrawal by Subject
|
1
|
|
Doxorubicin and Cyclophosphamide (AC)
Physician Decision
|
1
|
|
Doxorubicin and Cyclophosphamide (AC)
Participant Moved
|
1
|
|
Weekly Paclitaxel
Disease Progression
|
1
|
|
Weekly Paclitaxel
Adverse Event
|
11
|
|
Weekly Paclitaxel
Withdrawal by Subject
|
1
|
|
Weekly Paclitaxel
Physician Decision
|
3
|
|
Pazopanib Presurgery Treatment (PPT)
Adverse Event
|
52
|
|
Pazopanib Presurgery Treatment (PPT)
Withdrawal by Subject
|
4
|
|
Pazopanib Presurgery Treatment (PPT)
Physician Decision
|
1
|
|
Pazopanib Presurgery Treatment (PPT)
Never Started Pre-operative Pazopanib
|
1
|
|
Pazopanib Postsurgery Treatment
Adverse Event
|
19
|
|
Pazopanib Postsurgery Treatment
Withdrawal by Subject
|
5
|
|
Pazopanib Postsurgery Treatment
Moved
|
1
|
|
Pazopanib Postsurgery Treatment
Site Thought Treatment Was Completed
|
1
|
Baseline Characteristics
Treatment With Pazopanib for Neoadjuvant Breast Cancer
Baseline characteristics by cohort
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Age, Continuous
|
50.9 Years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage (W/C/EH)
|
81 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian (AI) or Alaskan Native (AN)
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AI or AN + White - W/C/EH
|
1 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
Estrogen receptor (ER) status positive
|
73 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
ER status negative
|
28 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
Progesterone receptor (PgR) status positive
|
62 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
PgR status negative
|
39 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
HER-2/NEU status positive
|
1 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
HER-2/NEU status negative
|
99 participants
n=5 Participants
|
|
Number of participants with a positive or negative status for the indicated hormone receptors
HER-2/NEU status equivocal (uncertain)
|
1 participants
n=5 Participants
|
|
Number of participants with the indicted hormonal status (ER+ and PR+ / ER- and PR-)
Positive
|
74 participants
n=5 Participants
|
|
Number of participants with the indicted hormonal status (ER+ and PR+ / ER- and PR-)
Negative
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)Population: Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=93 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes
|
16 Participants
|
SECONDARY outcome
Timeframe: From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)Population: Evaluable Population
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=93 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Pathologic Complete Response (pCR) in the Breast
|
18 Participants
|
SECONDARY outcome
Timeframe: From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entryPopulation: Evaluable Population
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=93 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period
|
22 Participants
|
SECONDARY outcome
Timeframe: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)Population: Evaluable Population
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=93 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
|
39 Participants
|
SECONDARY outcome
Timeframe: up to 24 months after study entryPopulation: Evaulable Population. Participants with recurrence before study entry were excluded from analysis.
IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=92 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Invasive Recurrence-free Interval (IRFI)
|
NA months
The median was not estimable because too few participants had events.
|
SECONDARY outcome
Timeframe: From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)Population: Treated Population: all participants who entered the study and received at least one dose of any study medication
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).Population: Treated Population
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
|
0 Participants
|
SECONDARY outcome
Timeframe: From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)Population: Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=42 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 months after study entryPopulation: Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.
The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
Elevated TSH at Least Once during the Study, n=101
|
28 participants
|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
AC Period, n=91
|
2 participants
|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
(WP) + Pazopanib Preoperative Periods, n=89
|
15 participants
|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
Surgery Period, n=78
|
1 participants
|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
Postoperative Pazopanib Period, n=36
|
7 participants
|
|
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
Follow-up Period, n=33
|
8 participants
|
SECONDARY outcome
Timeframe: up to 24 months after study entryPopulation: Treated Population
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With the Indicated Radiotherapy-related Complications
Pneumonitis
|
1 participants
|
|
Number of Participants With the Indicated Radiotherapy-related Complications
Rash
|
57 participants
|
SECONDARY outcome
Timeframe: up to 24 months after study entryPopulation: Evaulable Population, excluding participants with recurrence before study entry
The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.
Outcome measures
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=92 Participants
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Number of Participants With Recurrence Events
|
15 participants
|
Adverse Events
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
Serious events: 15 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 participants at risk
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
0.99%
1/101
|
|
Infections and infestations
Infection
|
2.0%
2/101
|
|
Infections and infestations
Perineal abscess
|
0.99%
1/101
|
|
Infections and infestations
Cellulitis
|
0.99%
1/101
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.0%
3/101
|
|
Blood and lymphatic system disorders
Anaemia
|
0.99%
1/101
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.99%
1/101
|
|
General disorders
Pyrexia
|
2.0%
2/101
|
|
Cardiac disorders
Myocardial ischaemia
|
0.99%
1/101
|
|
Gastrointestinal disorders
Nausea
|
0.99%
1/101
|
|
Gastrointestinal disorders
Vomiting
|
0.99%
1/101
|
|
Investigations
Alanine aminotransferase increased
|
0.99%
1/101
|
|
Nervous system disorders
Convulsion
|
0.99%
1/101
|
|
Psychiatric disorders
Depression
|
0.99%
1/101
|
|
Vascular disorders
Hypertension
|
0.99%
1/101
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.99%
1/101
|
Other adverse events
| Measure |
AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib
n=101 participants at risk
Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
71.3%
72/101
|
|
Gastrointestinal disorders
Diarrhoea
|
68.3%
69/101
|
|
Gastrointestinal disorders
Constipation
|
54.5%
55/101
|
|
Gastrointestinal disorders
Vomiting
|
33.7%
34/101
|
|
Gastrointestinal disorders
Stomatitis
|
24.8%
25/101
|
|
Gastrointestinal disorders
Dyspepsia
|
21.8%
22/101
|
|
Gastrointestinal disorders
Oral pain
|
12.9%
13/101
|
|
Gastrointestinal disorders
Flatulence
|
10.9%
11/101
|
|
Gastrointestinal disorders
Abdominal pain
|
9.9%
10/101
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.9%
7/101
|
|
Gastrointestinal disorders
Toothache
|
6.9%
7/101
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.9%
6/101
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
6/101
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
6/101
|
|
General disorders
Fatigue
|
92.1%
93/101
|
|
Gastrointestinal disorders
Pain
|
29.7%
30/101
|
|
General disorders
Pyrexia
|
18.8%
19/101
|
|
General disorders
Mucosal inflammation
|
17.8%
18/101
|
|
General disorders
Oedema peripheral
|
7.9%
8/101
|
|
General disorders
Influenza like illness
|
6.9%
7/101
|
|
General disorders
Chills
|
5.9%
6/101
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
69.3%
70/101
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
18.8%
19/101
|
|
Skin and subcutaneous tissue disorders
Rash
|
16.8%
17/101
|
|
Skin and subcutaneous tissue disorders
Erythema
|
14.9%
15/101
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.9%
13/101
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
7/101
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
6.9%
7/101
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
6.9%
7/101
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
5.9%
6/101
|
|
Nervous system disorders
Dysgeusia
|
44.6%
45/101
|
|
Nervous system disorders
Headache
|
35.6%
36/101
|
|
Nervous system disorders
Neuropathy peripheral
|
21.8%
22/101
|
|
Nervous system disorders
Paraesthesia
|
20.8%
21/101
|
|
Nervous system disorders
Dizziness
|
19.8%
20/101
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.8%
18/101
|
|
Nervous system disorders
Hypoaesthesia
|
11.9%
12/101
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
32.7%
33/101
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
29.7%
30/101
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.7%
29/101
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
23.8%
24/101
|
|
Investigations
Neutrophil count decreased
|
36.6%
37/101
|
|
Investigations
Alanine aminotransferase increased
|
14.9%
15/101
|
|
Investigations
Weight decreased
|
13.9%
14/101
|
|
Investigations
Aspartate aminotransferase increased
|
12.9%
13/101
|
|
Investigations
Weight increased
|
7.9%
8/101
|
|
Investigations
White blood cell count decreased
|
5.9%
6/101
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
29.7%
30/101
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
24.8%
25/101
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
19.8%
20/101
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.9%
15/101
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.9%
13/101
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.9%
10/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.9%
7/101
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.9%
7/101
|
|
Vascular disorders
Hot flush
|
39.6%
40/101
|
|
Vascular disorders
Hypertension
|
29.7%
30/101
|
|
Infections and infestations
Infection
|
16.8%
17/101
|
|
Infections and infestations
Nasopharyngitis
|
8.9%
9/101
|
|
Infections and infestations
Sinusitis
|
5.9%
6/101
|
|
Psychiatric disorders
Insomnia
|
32.7%
33/101
|
|
Psychiatric disorders
Anxiety
|
16.8%
17/101
|
|
Psychiatric disorders
Depression
|
8.9%
9/101
|
|
Psychiatric disorders
Mood altered
|
5.9%
6/101
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.7%
31/101
|
|
Metabolism and nutrition disorders
Dehydration
|
6.9%
7/101
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
9.9%
10/101
|
|
Injury, poisoning and procedural complications
Seroma
|
9.9%
10/101
|
|
Eye disorders
Vision blurred
|
10.9%
11/101
|
|
Eye disorders
Lacrimation increased
|
6.9%
7/101
|
|
Reproductive system and breast disorders
Breast pain
|
13.9%
14/101
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.9%
13/101
|
|
Endocrine disorders
Hypothyroidism
|
11.9%
12/101
|
|
Ear and labyrinth disorders
Ear pain
|
8.9%
9/101
|
|
Cardiac disorders
Palpitations
|
7.9%
8/101
|
|
Renal and urinary disorders
Dysuria
|
6.9%
7/101
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER