Trial Outcomes & Findings for Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer (NCT NCT00630032)
NCT ID: NCT00630032
Last Updated: 2024-02-21
Results Overview
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
762 participants
Primary outcome timeframe
At 5 years
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
Docetaxel
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
398
|
364
|
|
Overall Study
COMPLETED
|
308
|
269
|
|
Overall Study
NOT COMPLETED
|
90
|
95
|
Reasons for withdrawal
| Measure |
Docetaxel
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Overall Study
Death
|
55
|
49
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
18
|
31
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Patient has moved
|
1
|
1
|
|
Overall Study
Disease progression
|
1
|
1
|
|
Overall Study
End of monitoring in US centers
|
11
|
11
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Docetaxel
n=398 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
Total
n=762 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.5 years
n=398 Participants
|
53 years
n=364 Participants
|
53 years
n=762 Participants
|
|
Sex: Female, Male
Female
|
398 Participants
n=398 Participants
|
364 Participants
n=364 Participants
|
762 Participants
n=762 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=398 Participants
|
0 Participants
n=364 Participants
|
0 Participants
n=762 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Belgium
|
92 participants
n=398 Participants
|
74 participants
n=364 Participants
|
166 participants
n=762 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=398 Participants
|
13 participants
n=364 Participants
|
25 participants
n=762 Participants
|
|
Region of Enrollment
France
|
294 participants
n=398 Participants
|
277 participants
n=364 Participants
|
571 participants
n=762 Participants
|
PRIMARY outcome
Timeframe: At 5 yearsPopulation: The DFS was analyzed in the intention-to-treat population: All subjects randomized to a treatment arm with or without treatment (N=762).
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first
Outcome measures
| Measure |
Docetaxel
n=398 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Percentage of Participants With Disease-free Survival (DFS)
|
78.97 Percentage of participants
Interval 74.53 to 82.73
|
83.37 Percentage of participants
Interval 79.06 to 86.87
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: The DFS for triple-negative subgroup was analyzed in all triple negative breast cancer participants randomized to a treatment arm with or without treatment (N=586).
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only.
Outcome measures
| Measure |
Docetaxel
n=307 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=279 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Number of Disease-free Survival Events for Triple-negative Subgroup
|
69 Events
|
50 Events
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: The DFS for ER+/PR-/HER2- subgroup was analyzed in all ER+/PR-/HER2- breast cancer participants randomized to a treatment arm with or without treatment (N=167).
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only.
Outcome measures
| Measure |
Docetaxel
n=85 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=82 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup
|
21 Events
|
17 Events
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: The DFS was analyzed in the intention-to-treat population: All subjects randomized to a treatment arm with or without treatment (N=762).
The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
Outcome measures
| Measure |
Docetaxel
n=398 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Number of Distant Metastasis-free Survival Events for the Whole Population
|
82.3 Events
Interval 78.1 to 85.8
|
87.7 Events
Interval 83.8 to 90.7
|
SECONDARY outcome
Timeframe: At 5 yearsThe Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.
Outcome measures
| Measure |
Docetaxel
n=398 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Number of Event-free Survival
|
77.46 Events
Interval 72.94 to 81.32
|
81.53 Events
Interval 77.05 to 85.22
|
SECONDARY outcome
Timeframe: At 5 yearsPopulation: The OS was analyzed in the intention-to-treat population: All subjects randomized to a treatment arm with or without treatment (N=762).
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
Outcome measures
| Measure |
Docetaxel
n=398 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 Participants
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Overall Survival
|
87.00 percentage of participants
Interval 83.13 to 90.03
|
87.60 percentage of participants
Interval 83.64 to 90.66
|
Adverse Events
Docetaxel
Serious events: 207 serious events
Other events: 398 other events
Deaths: 58 deaths
Ixabepilone
Serious events: 158 serious events
Other events: 364 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Docetaxel
n=398 participants at risk
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 participants at risk
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian carcinoma
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Aplasia bone marrow
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Febrile aplasia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
1.1%
4/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
14.1%
56/398 • Throughtout the study, up to 5 years
|
7.4%
27/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Lymphocele
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
35.4%
141/398 • Throughtout the study, up to 5 years
|
26.1%
95/364 • Throughtout the study, up to 5 years
|
|
Cardiac disorders
Auricular fibrillation
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Cardiac disorders
Non ST segment elevation acute coronary syndrome
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Cardiac disorders
Tachycardia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Ear and labyrinth disorders
Ear disorder
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Eye disorders
Cataract (left)
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Eye disorders
Eye infection
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Crohn's enteritis
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction complicating hernia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Oesophagitis
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.50%
2/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.82%
3/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Epigastralgia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
1.6%
6/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
General disorders
Asthenia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
General disorders
Extravasation
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
General disorders
Fatigue
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
General disorders
Fever
|
1.3%
5/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
General disorders
Mucositis
|
0.50%
2/398 • Throughtout the study, up to 5 years
|
0.82%
3/364 • Throughtout the study, up to 5 years
|
|
General disorders
Pain
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Hepatobiliary disorders
Hepatic dysfunction NOS
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Immune system disorders
Allergic reaction
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Immune system disorders
Allergy
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.82%
3/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Infection
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Pneumonia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Pneumonia NOS
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Septic shock
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.82%
3/364 • Throughtout the study, up to 5 years
|
|
Injury, poisoning and procedural complications
Device complication
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Injury, poisoning and procedural complications
Device failure
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Injury, poisoning and procedural complications
Infection injection site
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Abscess soft tissue
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Muscular pain
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain bone
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.50%
2/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of cardia
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloid leukemia, acute
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pulmonary carcinoma
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of the cervix
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast carcinoma
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast ductal carcinoma
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma of tongue
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanoma
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreas cancer
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Epilepsy
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Pain nerve
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Schwannoma
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Cerebral hypoperfusion
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Intercostal neuralgia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Neuropathy
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
2.7%
10/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Sensory neuropathy
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
1.1%
4/364 • Throughtout the study, up to 5 years
|
|
Psychiatric disorders
Melancholia
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Renal and urinary disorders
Infection urinary tract
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Exfoliative dermatitis
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Fingernail discoloration
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.75%
3/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Recall phenomenon
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Allergic skin reaction
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Surgical and medical procedures
Device implant NOS
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.00%
0/364 • Throughtout the study, up to 5 years
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Vascular disorders
Pulmonary embolism
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.55%
2/364 • Throughtout the study, up to 5 years
|
|
Vascular disorders
Jugular vein thrombosis
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Vascular disorders
Thrombosis cerebral vein
|
0.25%
1/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
|
Vascular disorders
Venous thrombosis
|
0.50%
2/398 • Throughtout the study, up to 5 years
|
0.27%
1/364 • Throughtout the study, up to 5 years
|
Other adverse events
| Measure |
Docetaxel
n=398 participants at risk
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Cyclophosphamide: 500 mg/m² every 3 weeks Docetaxel: 100 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks
|
Ixabepilone
n=364 participants at risk
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Cyclophosphamide: 500 mg/m² every 3 weeks Epirubicin hydrochloride: 100 mg/m² every 3 weeks Fluorouracil: 500 mg/m² every 3 weeks Ixabepilone: 40 mg/m² every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
81.7%
325/398 • Throughtout the study, up to 5 years
|
78.8%
287/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.8%
67/398 • Throughtout the study, up to 5 years
|
14.3%
52/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
neutropenia
|
82.4%
328/398 • Throughtout the study, up to 5 years
|
86.3%
314/364 • Throughtout the study, up to 5 years
|
|
Blood and lymphatic system disorders
Thrombopenia
|
18.1%
72/398 • Throughtout the study, up to 5 years
|
23.9%
87/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
79.6%
317/398 • Throughtout the study, up to 5 years
|
84.3%
307/364 • Throughtout the study, up to 5 years
|
|
Cardiac disorders
Cardiovascular disorder
|
7.8%
31/398 • Throughtout the study, up to 5 years
|
12.4%
45/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Cutaneous
|
39.7%
158/398 • Throughtout the study, up to 5 years
|
31.0%
113/364 • Throughtout the study, up to 5 years
|
|
Cardiac disorders
Edema
|
16.8%
67/398 • Throughtout the study, up to 5 years
|
16.2%
59/364 • Throughtout the study, up to 5 years
|
|
General disorders
Fever
|
20.9%
83/398 • Throughtout the study, up to 5 years
|
19.5%
71/364 • Throughtout the study, up to 5 years
|
|
Hepatobiliary disorders
Hepatic
|
3.3%
13/398 • Throughtout the study, up to 5 years
|
11.8%
43/364 • Throughtout the study, up to 5 years
|
|
Infections and infestations
Infection
|
30.2%
120/398 • Throughtout the study, up to 5 years
|
33.8%
123/364 • Throughtout the study, up to 5 years
|
|
Vascular disorders
Mucitis
|
52.8%
210/398 • Throughtout the study, up to 5 years
|
50.8%
185/364 • Throughtout the study, up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
81.7%
325/398 • Throughtout the study, up to 5 years
|
81.0%
295/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Neurotoxicity peripheral
|
8.3%
33/398 • Throughtout the study, up to 5 years
|
16.2%
59/364 • Throughtout the study, up to 5 years
|
|
Nervous system disorders
Sensory neurotoxicity
|
24.9%
99/398 • Throughtout the study, up to 5 years
|
45.1%
164/364 • Throughtout the study, up to 5 years
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
25.1%
100/398 • Throughtout the study, up to 5 years
|
20.1%
73/364 • Throughtout the study, up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place