Trial Outcomes & Findings for Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa (NCT NCT01670500)
NCT ID: NCT01670500
Last Updated: 2025-04-09
Results Overview
Pathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
118 participants
Primary outcome timeframe
3 years
Results posted on
2025-04-09
Participant Flow
The trial was conducted at 13 academic centers and participants were recruited from these locations. Accrual occurred between January 2012 and January 2019.
Participant milestones
| Measure |
Doxorubicin-Cyclophosphamide
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
60
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Doxorubicin-Cyclophosphamide
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Stromal TILS missing for 5 in Doxorubicin-Cyclophosphamide arm and 4 in the Cisplatin arm
Baseline characteristics by cohort
| Measure |
Doxorubicin-Cyclophosphamide
n=58 Participants
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 Participants
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44 years
STANDARD_DEVIATION 10 • n=58 Participants
|
40 years
STANDARD_DEVIATION 9 • n=60 Participants
|
42 years
STANDARD_DEVIATION 10 • n=118 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=58 Participants
|
59 Participants
n=60 Participants
|
117 Participants
n=118 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=58 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=58 Participants
|
8 Participants
n=60 Participants
|
15 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=58 Participants
|
48 Participants
n=60 Participants
|
97 Participants
n=118 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=58 Participants
|
4 Participants
n=60 Participants
|
6 Participants
n=118 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=58 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=58 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=58 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=58 Participants
|
7 Participants
n=60 Participants
|
12 Participants
n=118 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=58 Participants
|
43 Participants
n=60 Participants
|
87 Participants
n=118 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=58 Participants
|
3 Participants
n=60 Participants
|
5 Participants
n=118 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=58 Participants
|
5 Participants
n=60 Participants
|
10 Participants
n=118 Participants
|
|
BRCA status
BRCA 1
|
37 Participants
n=58 Participants
|
44 Participants
n=60 Participants
|
81 Participants
n=118 Participants
|
|
BRCA status
BRCA 2
|
20 Participants
n=58 Participants
|
15 Participants
n=60 Participants
|
35 Participants
n=118 Participants
|
|
BRCA status
BRCA 1 and BRCA 2
|
1 Participants
n=58 Participants
|
1 Participants
n=60 Participants
|
2 Participants
n=118 Participants
|
|
Tumor size by imaging
|
2 centimeters
n=58 Participants
|
3 centimeters
n=60 Participants
|
2 centimeters
n=118 Participants
|
|
T Stage (Tumor Size)
T1
|
17 Participants
n=58 Participants
|
12 Participants
n=60 Participants
|
29 Participants
n=118 Participants
|
|
T Stage (Tumor Size)
T2
|
31 Participants
n=58 Participants
|
35 Participants
n=60 Participants
|
66 Participants
n=118 Participants
|
|
T Stage (Tumor Size)
T3
|
10 Participants
n=58 Participants
|
12 Participants
n=60 Participants
|
22 Participants
n=118 Participants
|
|
T Stage (Tumor Size)
unknown
|
0 Participants
n=58 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=118 Participants
|
|
N stage
N0
|
34 Participants
n=58 Participants
|
31 Participants
n=60 Participants
|
65 Participants
n=118 Participants
|
|
N stage
N1
|
19 Participants
n=58 Participants
|
24 Participants
n=60 Participants
|
43 Participants
n=118 Participants
|
|
N stage
N2
|
2 Participants
n=58 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=118 Participants
|
|
N stage
N3
|
3 Participants
n=58 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=118 Participants
|
|
Node status: biopsy before chemotherapy
positive
|
24 Participants
n=58 Participants
|
29 Participants
n=60 Participants
|
53 Participants
n=118 Participants
|
|
Node status: biopsy before chemotherapy
negative
|
34 Participants
n=58 Participants
|
31 Participants
n=60 Participants
|
65 Participants
n=118 Participants
|
|
Stage
I
|
15 Participants
n=58 Participants
|
8 Participants
n=60 Participants
|
23 Participants
n=118 Participants
|
|
Stage
II
|
34 Participants
n=58 Participants
|
40 Participants
n=60 Participants
|
74 Participants
n=118 Participants
|
|
Stage
III
|
9 Participants
n=58 Participants
|
12 Participants
n=60 Participants
|
21 Participants
n=118 Participants
|
|
Estrogen Receptor (ER)
Positive (>/= 1%)
|
20 Participants
n=58 Participants
|
20 Participants
n=60 Participants
|
40 Participants
n=118 Participants
|
|
Estrogen Receptor (ER)
Negative (< 1%)
|
38 Participants
n=58 Participants
|
40 Participants
n=60 Participants
|
78 Participants
n=118 Participants
|
|
Hormone receptor 1% cutoff
Triple Negative Breast Cancer (ER & PR < 1%)
|
36 Participants
n=58 Participants
|
40 Participants
n=60 Participants
|
76 Participants
n=118 Participants
|
|
Hormone receptor 1% cutoff
ER+ or PR+
|
22 Participants
n=58 Participants
|
20 Participants
n=60 Participants
|
42 Participants
n=118 Participants
|
|
Histology
Invasive ductal
|
52 Participants
n=58 Participants
|
57 Participants
n=60 Participants
|
109 Participants
n=118 Participants
|
|
Histology
Invasive lobular
|
2 Participants
n=58 Participants
|
2 Participants
n=60 Participants
|
4 Participants
n=118 Participants
|
|
Histology
Mixed
|
3 Participants
n=58 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=118 Participants
|
|
Histology
Other
|
1 Participants
n=58 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=118 Participants
|
|
Pre-chemotherapy tumor grade
1
|
1 Participants
n=58 Participants
|
2 Participants
n=60 Participants
|
3 Participants
n=118 Participants
|
|
Pre-chemotherapy tumor grade
2
|
12 Participants
n=58 Participants
|
11 Participants
n=60 Participants
|
23 Participants
n=118 Participants
|
|
Pre-chemotherapy tumor grade
3
|
45 Participants
n=58 Participants
|
46 Participants
n=60 Participants
|
91 Participants
n=118 Participants
|
|
Pre-chemotherapy tumor grade
unknown
|
0 Participants
n=58 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=118 Participants
|
|
Lymphovascular invasion
Present
|
11 Participants
n=58 Participants
|
12 Participants
n=60 Participants
|
23 Participants
n=118 Participants
|
|
Lymphovascular invasion
Absent
|
47 Participants
n=58 Participants
|
48 Participants
n=60 Participants
|
95 Participants
n=118 Participants
|
|
lymphocytic infiltrate
moderate/marked
|
22 Participants
n=58 Participants
|
21 Participants
n=60 Participants
|
43 Participants
n=118 Participants
|
|
lymphocytic infiltrate
absent/scant
|
33 Participants
n=58 Participants
|
36 Participants
n=60 Participants
|
69 Participants
n=118 Participants
|
|
lymphocytic infiltrate
unknown
|
3 Participants
n=58 Participants
|
3 Participants
n=60 Participants
|
6 Participants
n=118 Participants
|
|
Stromal TILs
|
10 percentage of stromal TILs
n=53 Participants • Stromal TILS missing for 5 in Doxorubicin-Cyclophosphamide arm and 4 in the Cisplatin arm
|
10 percentage of stromal TILs
n=56 Participants • Stromal TILS missing for 5 in Doxorubicin-Cyclophosphamide arm and 4 in the Cisplatin arm
|
10 percentage of stromal TILs
n=109 Participants • Stromal TILS missing for 5 in Doxorubicin-Cyclophosphamide arm and 4 in the Cisplatin arm
|
PRIMARY outcome
Timeframe: 3 yearsPathologic complete response (pCR) rate (determined by the Miller-Payne method) in doxorubicin-cyclophosphamide vs cisplatin arms.
Outcome measures
| Measure |
Doxorubicin-Cyclophosphamide
n=57 Participants
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 Participants
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Rate of Pathologic Complete Response (pCR)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsResidual Cancer Burden (RCB) rate of RCB 0 or 1 in participants receiving Doxorubicin-Cyclophosphamide vs participants receiving Cisplatin.
Outcome measures
| Measure |
Doxorubicin-Cyclophosphamide
n=57 Participants
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 Participants
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Rate of Residual Cancer Burden (RCB) 0/1
|
46 percentage of participants
|
33 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsClinical response rate, defined as the number of partial and complete responses, after preoperative therapy with either cisplatin or AC in participants with germline BRCA mutation and breast cancer. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or ultrasound: Complete Response (CR) = Disappearance of all target lesions; Partial Response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Doxorubicin-Cyclophosphamide
n=58 Participants
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 Participants
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Clinical Response Rate
|
43 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: 2 yearsComparison of toxicities for cisplatin and AC preoperative chemotherapy in BRCA mutation carriers with newly diagnosed breast cancer, reported as number of all Grade 3 and 4 adverse events and number of non-hematologic Grade 3 and 4 adverse events.
Outcome measures
| Measure |
Doxorubicin-Cyclophosphamide
n=57 Participants
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 Participants
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Number of Grade 3 and Grade 4 Adverse Events
All Grade 3 & 4 Adverse Events
|
15 Adverse Events
|
16 Adverse Events
|
|
Number of Grade 3 and Grade 4 Adverse Events
Non-hematologic Grade 3 & 4 Adverse Events
|
4 Adverse Events
|
11 Adverse Events
|
SECONDARY outcome
Timeframe: 5 yearsBiopsies collected for future analyses of biomarkers that predict for response to cisplatin or AC chemotherapy in BRCA mutation carriers. Pretreatment tumor biopsies will be analyzed using genome wide SNP profiling to determine number of regions of telomeric allelic imbalance (NtAI) and chromosome 15q26 copy number, and chromosome 8q22 copy number. Tumor sections will be examined for gene amplifications, losses and NtAI in tumors. Gene expression profiling will be performed to determine intrinsic subtype (basal-like, claudin-low, etc.) and to measure biomarker genes including BLM and FANCI associated with cisplatin sensitivity or LAPTM4B and YWHAZ associated with anthracycline resistance. Exploratory analysis will be performed to seek new measures of therapy response using the data from DNA copy number and gene expression profiles. In addition, we will plan to perform whole exome and possibly whole genome sequencing of tumors to identify potential modifiers of response to therapy.
Outcome measures
Outcome data not reported
Adverse Events
Doxorubicin-Cyclophosphamide
Serious events: 6 serious events
Other events: 55 other events
Deaths: 0 deaths
Cisplatin
Serious events: 5 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin-Cyclophosphamide
n=57 participants at risk
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 participants at risk
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
Immune system disorders
Allergic Reaction
|
1.8%
1/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
0.00%
0/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
1.7%
1/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
3.3%
2/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Infections and infestations
Breast Infection
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
1.7%
1/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Investigations
Neutrophil Count Decreased
|
7.0%
4/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
0.00%
0/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
1.7%
1/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Investigations
Increased Creatinine
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
3.3%
2/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
1.8%
1/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
0.00%
0/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
Other adverse events
| Measure |
Doxorubicin-Cyclophosphamide
n=57 participants at risk
Doxorubicin q 2-3 wk x 4 Cyclophosphamide q 2-3 wk x 4
Cyclophosphamide: administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
Doxorubicin: administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
|
Cisplatin
n=60 participants at risk
Cisplatin q 3 wk x 4
Cisplatin: administered intravenously every 3 weeks for 4 doses
|
|---|---|---|
|
General disorders
Fatigue
|
78.9%
45/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
80.0%
48/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Gastrointestinal disorders
Nausea
|
70.2%
40/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
86.7%
52/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
53.3%
32/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
9/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
21.7%
13/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
17.5%
10/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
11.7%
7/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Investigations
Decreased Neutrophil Count
|
8.8%
5/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
13.3%
8/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Investigations
Decreased White Blood Cell Count
|
8.8%
5/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
6.7%
4/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Investigations
Decreased lymphocyte count
|
5.3%
3/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
1.7%
1/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.4%
31/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
6.7%
4/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.5%
2/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
5.0%
3/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Nervous system disorders
Headache
|
12.3%
7/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
6.7%
4/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Gastrointestinal disorders
Constipation
|
35.1%
20/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
21.7%
13/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Blood and lymphatic system disorders
Anemia
|
22.8%
13/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
25.0%
15/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Gastrointestinal disorders
Oral Mucositis
|
26.3%
15/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
11.7%
7/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
|
Nervous system disorders
Dysgeusia
|
24.6%
14/57 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
10.0%
6/60 • Adverse event information was collected from time of treatment start, during treatment, and until 30 days after the last dose of treatment, about 3 months on average per participant, an average of 2 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place