Trial Outcomes & Findings for Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer (NCT NCT00068341)
NCT ID: NCT00068341
Last Updated: 2020-09-09
Results Overview
Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) \& disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
5 years
Results posted on
2020-09-09
Participant Flow
Dates of recruitment period: 2002-2007 Types of location: oncology outpatient clinics
Participant milestones
| Measure |
Arm I (Neoadjuvant Therapy)
see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV (AUC = area under the curve, total drug exposure over time)
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
|
Arm II (Neoadjuvant Therapy)
please see intervention description
trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
HER2/Neu Negative Patients
please see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
44
|
|
Overall Study
COMPLETED
|
15
|
15
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Neoadjuvant Therapy)
n=15 Participants
see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
|
Arm II (Neoadjuvant Therapy)
n=15 Participants
please see intervention description
trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
HER2/Neu Negative Patients
n=44 Participants
please see intervention description
carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV
docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
74 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
44 participants
n=5 Participants
|
74 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group \[1 protocol violation, 1 bilateral disease\] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group \[protocol violation\]
Objective response rate of patients treated with Taxotere/carboplatin with or without Herceptin preoperatively. Objective response equals the combination of complete response (CR), partial response (PR) and marginal response (MR). Tumor size was assessed by (1) physical examination, (2) mammography and (3) MRI. 5 response groups: complete response (CR), partial response (PR), marginal response (MR), stable disease (SD) \& disease progression (DP). Pathologic response assigned into 2 groups: pCR and non-pCR. pCR-no evidence of residual invasive disease in specimen.
Outcome measures
| Measure |
Arm I: HER2+
n=15 Participants
(Pre-Op TCH)
|
Arm II: HER2+
n=14 Participants
(Pre-Op TC, Post-Op Herceptin)
|
HER2-
n=42 Participants
(Pre-Op TC)
|
Total
n=71 Participants
|
|---|---|---|---|---|
|
Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.
DFS (Disease Free Survival)
|
13 participants
|
8 participants
|
33 participants
|
54 participants
|
|
Evaluate the Objective Response Rate of Patients Treated With Taxotere/Carboplatin With or Without Herceptin Preoperatively.
OS (overall survival)
|
13 participants
|
11 participants
|
39 participants
|
63 participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: Clinical response was not assessed for 2 patients in the HER2 - (Pre-Op TC) group \[1 protocol violation, 1 bilateral disease\] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group \[protocol violation\]
Outcome measures
| Measure |
Arm I: HER2+
n=15 Participants
(Pre-Op TCH)
|
Arm II: HER2+
n=13 Participants
(Pre-Op TC, Post-Op Herceptin)
|
HER2-
n=43 Participants
(Pre-Op TC)
|
Total
|
|---|---|---|---|---|
|
Clinical Tumor Response by Physical Exam and Imaging Studies
Complete Response
|
8 participants
|
5 participants
|
18 participants
|
—
|
|
Clinical Tumor Response by Physical Exam and Imaging Studies
Partial Response
|
7 participants
|
7 participants
|
21 participants
|
—
|
|
Clinical Tumor Response by Physical Exam and Imaging Studies
Marginal Response
|
0 participants
|
1 participants
|
4 participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: pCR was not assessed for 2 patients in the HER2 - (Pre-Op TC) group \[1 protocol violation, 1 bilateral disease\] and for 1 patient in the HER2+ (Pre-Op TC, Post-Op Herceptin) group \[protocol violation\]"
Measured by physical examination compared to breast mammography and MRI assessment
Outcome measures
| Measure |
Arm I: HER2+
n=15 Participants
(Pre-Op TCH)
|
Arm II: HER2+
n=13 Participants
(Pre-Op TC, Post-Op Herceptin)
|
HER2-
n=43 Participants
(Pre-Op TC)
|
Total
|
|---|---|---|---|---|
|
Tumor Response Assessment
|
6 participants
|
1 participants
|
12 participants
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2), FISH (Fluorescence in situ hybridization), IDC (invasive ductal carcinoma), ILC (invasive lobular carcinoma),
Outcome measures
| Measure |
Arm I: HER2+
n=74 Participants
(Pre-Op TCH)
|
Arm II: HER2+
n=74 Participants
(Pre-Op TC, Post-Op Herceptin)
|
HER2-
(Pre-Op TC)
|
Total
|
|---|---|---|---|---|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
FISH positive Herceptin No
|
1 participants
|
13 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Tumor Type - IDC only
|
19 participants
|
38 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Tumor Type - all others (compared to IDC only)
|
0 participants
|
14 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
ER-negative
|
11 participants
|
14 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
ER-positive
|
8 participants
|
38 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
PR-negative
|
14 participants
|
24 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
PR-positive
|
5 participants
|
28 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
ER and PR both negative
|
9 participants
|
14 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
ER and PR one negative
|
7 participants
|
10 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
ER and PR both positive
|
3 participants
|
28 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
HER2 negative
|
12 participants
|
30 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
HER2 positive
|
7 participants
|
22 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
T-Stage T2
|
5 participants
|
9 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
T-Stage T3
|
13 participants
|
27 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
T-Stage T4
|
1 participants
|
16 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Tumor Type - ILC only
|
0 participants
|
9 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Tumor Type - all other comparted to (ICL only)
|
19 participants
|
43 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Triple Negative-yes
|
6 participants
|
5 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
Triple Negative-no
|
7 participants
|
38 participants
|
—
|
—
|
|
Clinico-histologic Predictors of pCR (Pathologic Complete Response)
FISH positive Herceptin Yes
|
6 participants
|
9 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: only 71 subjects of the 74 subjects could be analyzed for this outcome measure due to data collection error.
According to Primary Tumor Response Pathologic lymph node status N0 Axillary and other nearby lymph nodes do not have cancer (when looked at under a microscope) N1 Micrometastases (very small clusters of cancer) OR 1-3 axillary lymph nodes have cancer AND/OR Internal mammary nodes have tiny amounts of cancer found on sentinel node biopsy N2 4-9 axillary lymph nodes have cancer OR Internal mammary nodes have cancer, but axillary lymph nodes do not have cancer N3 10 or more axillary lymph nodes have cancer OR Infraclavicular (under the clavicle) nodes have cancer OR Internal mammary nodes have cancer plus 1 or more axillary lymph nodes have cancer OR 4 or more axillary lymph nodes have cancer plus internal mammary nodes have cancer or micrometastases found on sentinel node biopsy OR Supraclavicular (above the clavicle) nodes have cancer
Outcome measures
| Measure |
Arm I: HER2+
n=15 Participants
(Pre-Op TCH)
|
Arm II: HER2+
n=14 Participants
(Pre-Op TC, Post-Op Herceptin)
|
HER2-
n=42 Participants
(Pre-Op TC)
|
Total
|
|---|---|---|---|---|
|
Pathologic Nodal Status
N(0)
|
9 participants
|
4 participants
|
21 participants
|
—
|
|
Pathologic Nodal Status
N+
|
6 participants
|
11 participants
|
23 participants
|
—
|
Adverse Events
Arm I: HER+ (Pre-Op TCH)
Serious events: 6 serious events
Other events: 15 other events
Deaths: 6 deaths
Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)
Serious events: 4 serious events
Other events: 12 other events
Deaths: 4 deaths
Arm III: HER2- (Pre-Op TC)
Serious events: 10 serious events
Other events: 45 other events
Deaths: 10 deaths
Total
Serious events: 20 serious events
Other events: 72 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Arm I: HER+ (Pre-Op TCH)
n=15 participants at risk
Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
|
Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)
n=14 participants at risk
Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
|
Arm III: HER2- (Pre-Op TC)
n=45 participants at risk
HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
Total
n=74 participants at risk
|
|---|---|---|---|---|
|
General disorders
Severe Dehydration
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
2.7%
2/74 • Number of events 2 • 3 years from 1st study drug administration
|
|
Infections and infestations
febrile neutropenia
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 4 • 3 years from 1st study drug administration
|
12.2%
9/74 • Number of events 9 • 3 years from 1st study drug administration
|
|
General disorders
hypokalemia
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
0.00%
0/45 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
Infections and infestations
Neutropenia
|
0.00%
0/15 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
Skin and subcutaneous tissue disorders
Upper Extremity Cellulites
|
0.00%
0/15 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
2.7%
2/74 • Number of events 2 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
diarrhea and dehydration
|
0.00%
0/15 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
General disorders
pain, swelling, mastectomy site cellulitis
|
0.00%
0/15 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
General disorders
death progressive disease
|
0.00%
0/15 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/45 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
General disorders
divetricular abscess
|
0.00%
0/15 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
|
General disorders
fever
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
0.00%
0/45 • 3 years from 1st study drug administration
|
1.4%
1/74 • Number of events 1 • 3 years from 1st study drug administration
|
Other adverse events
| Measure |
Arm I: HER+ (Pre-Op TCH)
n=15 participants at risk
Arm I carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV trastuzumab: Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
|
Arm II: HER2+ (Pre-Op TC, Post-Op Herceptin)
n=14 participants at risk
Arm II trastuzumab: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
|
Arm III: HER2- (Pre-Op TC)
n=45 participants at risk
HER2/neu negative patients carboplatin: Cycle 1-8 Day 1 or 2 AUC = 6 IV docetaxel: Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
|
Total
n=74 participants at risk
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
80.0%
12/15 • Number of events 14 • 3 years from 1st study drug administration
|
78.6%
11/14 • Number of events 21 • 3 years from 1st study drug administration
|
80.0%
36/45 • Number of events 50 • 3 years from 1st study drug administration
|
79.7%
59/74 • Number of events 85 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Anemia
|
86.7%
13/15 • Number of events 42 • 3 years from 1st study drug administration
|
78.6%
11/14 • Number of events 50 • 3 years from 1st study drug administration
|
71.1%
32/45 • Number of events 83 • 3 years from 1st study drug administration
|
75.7%
56/74 • Number of events 175 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
Investigations
ALT Elevated
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 7 • 3 years from 1st study drug administration
|
17.8%
8/45 • Number of events 13 • 3 years from 1st study drug administration
|
17.6%
13/74 • Number of events 23 • 3 years from 1st study drug administration
|
|
Investigations
APT Elevated
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
17.8%
8/45 • Number of events 11 • 3 years from 1st study drug administration
|
16.2%
12/74 • Number of events 15 • 3 years from 1st study drug administration
|
|
Investigations
AST Elevated
|
13.3%
2/15 • Number of events 3 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 3 • 3 years from 1st study drug administration
|
15.6%
7/45 • Number of events 10 • 3 years from 1st study drug administration
|
16.2%
12/74 • Number of events 16 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 2 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Investigations
Albumin Decreased
|
0.00%
0/15 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 4 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
5.4%
4/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Anorexia
|
13.3%
2/15 • Number of events 4 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 5 • 3 years from 1st study drug administration
|
28.9%
13/45 • Number of events 47 • 3 years from 1st study drug administration
|
23.0%
17/74 • Number of events 56 • 3 years from 1st study drug administration
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/15 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 2 • 3 years from 1st study drug administration
|
4.4%
2/45 • Number of events 2 • 3 years from 1st study drug administration
|
4.1%
3/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Appetite Change
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
28.6%
4/14 • Number of events 6 • 3 years from 1st study drug administration
|
22.2%
10/45 • Number of events 12 • 3 years from 1st study drug administration
|
21.6%
16/74 • Number of events 20 • 3 years from 1st study drug administration
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 4 • 3 years from 1st study drug administration
|
22.2%
10/45 • Number of events 17 • 3 years from 1st study drug administration
|
21.6%
16/74 • Number of events 24 • 3 years from 1st study drug administration
|
|
Eye disorders
Blurry Vision
|
0.00%
0/15 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
Musculoskeletal and connective tissue disorders
Body Ache
|
46.7%
7/15 • Number of events 19 • 3 years from 1st study drug administration
|
78.6%
11/14 • Number of events 23 • 3 years from 1st study drug administration
|
42.2%
19/45 • Number of events 35 • 3 years from 1st study drug administration
|
50.0%
37/74 • Number of events 77 • 3 years from 1st study drug administration
|
|
Musculoskeletal and connective tissue disorders
Chest Complain
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 3 • 3 years from 1st study drug administration
|
11.1%
5/45 • Number of events 6 • 3 years from 1st study drug administration
|
10.8%
8/74 • Number of events 10 • 3 years from 1st study drug administration
|
|
General disorders
Chills
|
20.0%
3/15 • Number of events 6 • 3 years from 1st study drug administration
|
28.6%
4/14 • Number of events 4 • 3 years from 1st study drug administration
|
4.4%
2/45 • Number of events 2 • 3 years from 1st study drug administration
|
12.2%
9/74 • Number of events 12 • 3 years from 1st study drug administration
|
|
General disorders
Cold Symptons
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 6 • 3 years from 1st study drug administration
|
15.6%
7/45 • Number of events 13 • 3 years from 1st study drug administration
|
16.2%
12/74 • Number of events 21 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Constipation
|
40.0%
6/15 • Number of events 10 • 3 years from 1st study drug administration
|
35.7%
5/14 • Number of events 7 • 3 years from 1st study drug administration
|
53.3%
24/45 • Number of events 52 • 3 years from 1st study drug administration
|
47.3%
35/74 • Number of events 69 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • Number of events 4 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Diarrhea
|
33.3%
5/15 • Number of events 19 • 3 years from 1st study drug administration
|
57.1%
8/14 • Number of events 8 • 3 years from 1st study drug administration
|
42.2%
19/45 • Number of events 26 • 3 years from 1st study drug administration
|
43.2%
32/74 • Number of events 53 • 3 years from 1st study drug administration
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 5 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
12.2%
9/74 • Number of events 10 • 3 years from 1st study drug administration
|
|
Musculoskeletal and connective tissue disorders
Dry Mucosa
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 5 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 8 • 3 years from 1st study drug administration
|
|
General disorders
Edema
|
46.7%
7/15 • Number of events 7 • 3 years from 1st study drug administration
|
35.7%
5/14 • Number of events 15 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
20.3%
15/74 • Number of events 25 • 3 years from 1st study drug administration
|
|
Skin and subcutaneous tissue disorders
Erythema
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
Eye disorders
Eye Tearing
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
4.4%
2/45 • Number of events 2 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
General disorders
Fever
|
20.0%
3/15 • Number of events 5 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 5 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
9.5%
7/74 • Number of events 11 • 3 years from 1st study drug administration
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • Number of events 8 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 3 • 3 years from 1st study drug administration
|
28.9%
13/45 • Number of events 16 • 3 years from 1st study drug administration
|
27.0%
20/74 • Number of events 27 • 3 years from 1st study drug administration
|
|
Vascular disorders
Hot Flashes
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
17.8%
8/45 • Number of events 8 • 3 years from 1st study drug administration
|
14.9%
11/74 • Number of events 11 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
13.3%
6/45 • Number of events 12 • 3 years from 1st study drug administration
|
10.8%
8/74 • Number of events 14 • 3 years from 1st study drug administration
|
|
General disorders
Hypersensitivity
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
13.3%
6/45 • Number of events 8 • 3 years from 1st study drug administration
|
9.5%
7/74 • Number of events 9 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.7%
1/15 • Number of events 3 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
4.4%
2/45 • Number of events 2 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hypokalemia
|
26.7%
4/15 • Number of events 4 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 7 • 3 years from 1st study drug administration
|
13.3%
6/45 • Number of events 9 • 3 years from 1st study drug administration
|
17.6%
13/74 • Number of events 20 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.3%
2/15 • Number of events 3 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 3 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 6 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Indigestion
|
13.3%
2/15 • Number of events 3 • 3 years from 1st study drug administration
|
42.9%
6/14 • Number of events 11 • 3 years from 1st study drug administration
|
26.7%
12/45 • Number of events 17 • 3 years from 1st study drug administration
|
27.0%
20/74 • Number of events 31 • 3 years from 1st study drug administration
|
|
Psychiatric disorders
Insomnia
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
21.4%
3/14 • Number of events 4 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 7 • 3 years from 1st study drug administration
|
13.5%
10/74 • Number of events 14 • 3 years from 1st study drug administration
|
|
Reproductive system and breast disorders
Irregular Menstruation
|
6.7%
1/15 • Number of events 2 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 4 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Leukopenia
|
86.7%
13/15 • Number of events 29 • 3 years from 1st study drug administration
|
50.0%
7/14 • Number of events 50 • 3 years from 1st study drug administration
|
68.9%
31/45 • Number of events 116 • 3 years from 1st study drug administration
|
68.9%
51/74 • Number of events 195 • 3 years from 1st study drug administration
|
|
Reproductive system and breast disorders
Hot Flashes
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
17.8%
8/45 • Number of events 8 • 3 years from 1st study drug administration
|
14.9%
11/74 • Number of events 11 • 3 years from 1st study drug administration
|
|
Endocrine disorders
Hypergylcemia
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
13.3%
6/45 • Number of events 12 • 3 years from 1st study drug administration
|
10.8%
8/74 • Number of events 14 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • Number of events 3 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
4.4%
2/45 • Number of events 2 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Lymphopenia
|
46.7%
7/15 • Number of events 7 • 3 years from 1st study drug administration
|
28.6%
4/14 • Number of events 30 • 3 years from 1st study drug administration
|
37.8%
17/45 • Number of events 38 • 3 years from 1st study drug administration
|
37.8%
28/74 • Number of events 75 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Mouth Sore
|
66.7%
10/15 • Number of events 18 • 3 years from 1st study drug administration
|
57.1%
8/14 • Number of events 12 • 3 years from 1st study drug administration
|
24.4%
11/45 • Number of events 21 • 3 years from 1st study drug administration
|
39.2%
29/74 • Number of events 51 • 3 years from 1st study drug administration
|
|
Skin and subcutaneous tissue disorders
Nail Change
|
20.0%
3/15 • Number of events 3 • 3 years from 1st study drug administration
|
35.7%
5/14 • Number of events 5 • 3 years from 1st study drug administration
|
24.4%
11/45 • Number of events 12 • 3 years from 1st study drug administration
|
25.7%
19/74 • Number of events 20 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Nausea
|
86.7%
13/15 • Number of events 34 • 3 years from 1st study drug administration
|
85.7%
12/14 • Number of events 45 • 3 years from 1st study drug administration
|
71.1%
32/45 • Number of events 106 • 3 years from 1st study drug administration
|
77.0%
57/74 • Number of events 185 • 3 years from 1st study drug administration
|
|
Nervous system disorders
Neuropathy
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 2 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 4 • 3 years from 1st study drug administration
|
9.5%
7/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Neutropenia
|
66.7%
10/15 • Number of events 25 • 3 years from 1st study drug administration
|
57.1%
8/14 • Number of events 35 • 3 years from 1st study drug administration
|
75.6%
34/45 • Number of events 116 • 3 years from 1st study drug administration
|
70.3%
52/74 • Number of events 176 • 3 years from 1st study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Nose Bleed
|
6.7%
1/15 • Number of events 2 • 3 years from 1st study drug administration
|
7.1%
1/14 • Number of events 1 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 5 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 8 • 3 years from 1st study drug administration
|
|
Nervous system disorders
Numbness/Tingling
|
40.0%
6/15 • Number of events 8 • 3 years from 1st study drug administration
|
42.9%
6/14 • Number of events 7 • 3 years from 1st study drug administration
|
22.2%
10/45 • Number of events 17 • 3 years from 1st study drug administration
|
29.7%
22/74 • Number of events 32 • 3 years from 1st study drug administration
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
42.9%
6/14 • Number of events 8 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
12.2%
9/74 • Number of events 11 • 3 years from 1st study drug administration
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
13.3%
2/15 • Number of events 3 • 3 years from 1st study drug administration
|
35.7%
5/14 • Number of events 6 • 3 years from 1st study drug administration
|
11.1%
5/45 • Number of events 6 • 3 years from 1st study drug administration
|
16.2%
12/74 • Number of events 15 • 3 years from 1st study drug administration
|
|
Skin and subcutaneous tissue disorders
Skin Changes
|
0.00%
0/15 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
6.7%
3/45 • Number of events 4 • 3 years from 1st study drug administration
|
4.1%
3/74 • Number of events 4 • 3 years from 1st study drug administration
|
|
General disorders
Sweats
|
13.3%
2/15 • Number of events 4 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 3 • 3 years from 1st study drug administration
|
15.6%
7/45 • Number of events 9 • 3 years from 1st study drug administration
|
14.9%
11/74 • Number of events 16 • 3 years from 1st study drug administration
|
|
Cardiac disorders
Tachycardia
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 4 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 5 • 3 years from 1st study drug administration
|
|
General disorders
Taste Change
|
33.3%
5/15 • Number of events 8 • 3 years from 1st study drug administration
|
42.9%
6/14 • Number of events 7 • 3 years from 1st study drug administration
|
33.3%
15/45 • Number of events 20 • 3 years from 1st study drug administration
|
35.1%
26/74 • Number of events 35 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Throat Complaint
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
4.1%
3/74 • Number of events 3 • 3 years from 1st study drug administration
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
60.0%
9/15 • Number of events 19 • 3 years from 1st study drug administration
|
57.1%
8/14 • Number of events 24 • 3 years from 1st study drug administration
|
48.9%
22/45 • Number of events 52 • 3 years from 1st study drug administration
|
52.7%
39/74 • Number of events 95 • 3 years from 1st study drug administration
|
|
Eye disorders
Vision Change
|
6.7%
1/15 • Number of events 1 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 5 • 3 years from 1st study drug administration
|
6.8%
5/74 • Number of events 6 • 3 years from 1st study drug administration
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • Number of events 25 • 3 years from 1st study drug administration
|
28.6%
4/14 • Number of events 5 • 3 years from 1st study drug administration
|
35.6%
16/45 • Number of events 30 • 3 years from 1st study drug administration
|
37.8%
28/74 • Number of events 60 • 3 years from 1st study drug administration
|
|
General disorders
Weakness/Fatigue
|
86.7%
13/15 • Number of events 34 • 3 years from 1st study drug administration
|
85.7%
12/14 • Number of events 37 • 3 years from 1st study drug administration
|
91.1%
41/45 • Number of events 155 • 3 years from 1st study drug administration
|
89.2%
66/74 • Number of events 226 • 3 years from 1st study drug administration
|
|
General disorders
Weight Change
|
13.3%
2/15 • Number of events 2 • 3 years from 1st study drug administration
|
0.00%
0/14 • 3 years from 1st study drug administration
|
8.9%
4/45 • Number of events 5 • 3 years from 1st study drug administration
|
8.1%
6/74 • Number of events 7 • 3 years from 1st study drug administration
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
0.00%
0/15 • 3 years from 1st study drug administration
|
14.3%
2/14 • Number of events 3 • 3 years from 1st study drug administration
|
2.2%
1/45 • Number of events 1 • 3 years from 1st study drug administration
|
4.1%
3/74 • Number of events 4 • 3 years from 1st study drug administration
|
Additional Information
Helena Chang, M.D., Ph.D., Revlon/UCLA Breast Center
Jonsson Comprehensive Cancer Center
Phone: 310-794-5640
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place