Trial Outcomes & Findings for EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer (NCT NCT00129935)
NCT ID: NCT00129935
Last Updated: 2023-03-31
Results Overview
A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1384 participants
Primary outcome timeframe
5 years
Results posted on
2023-03-31
Participant Flow
1,384 patients were recruited in 58 Spanish centers and randomized to receive EC-T (n=669) or ET-X (n=715). 5 patients received no treatment in the ET-X arm. 4 patients were not treated with the study medication to which they were randomized (n=3 EC-T arm; n=1 ET-X arm). 1,378 patients were evaluable for safety (n=667 and 711 respectively).
Participant milestones
| Measure |
Arm A: EC-T
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Overall Study
STARTED
|
669
|
715
|
|
Overall Study
COMPLETED
|
633
|
623
|
|
Overall Study
NOT COMPLETED
|
36
|
92
|
Reasons for withdrawal
| Measure |
Arm A: EC-T
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Overall Study
Adverse Event
|
18
|
56
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
7
|
20
|
|
Overall Study
Protocol Violation
|
0
|
4
|
|
Overall Study
Physician Decision
|
3
|
4
|
|
Overall Study
Recurrence
|
1
|
3
|
|
Overall Study
Second primary
|
0
|
1
|
|
Overall Study
Other
|
3
|
2
|
|
Overall Study
Crossed to the other arm
|
2
|
1
|
|
Overall Study
Incorrect study treatment
|
1
|
0
|
Baseline Characteristics
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A: EC-T
n=669 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=715 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
Total
n=1384 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
51 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
669 Participants
n=5 Participants
|
715 Participants
n=7 Participants
|
1384 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
669 participants
n=5 Participants
|
715 participants
n=7 Participants
|
1384 participants
n=5 Participants
|
|
Karnofsky Performance Status (PS)
PS 80
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Karnofsky Performance Status (PS)
PS 90
|
75 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Karnofsky Performance Status (PS)
PS 100
|
582 Participants
n=5 Participants
|
629 Participants
n=7 Participants
|
1211 Participants
n=5 Participants
|
|
Karnofsky Performance Status (PS)
Unknown
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Menopausal status
Premenopausal
|
349 Participants
n=5 Participants
|
382 Participants
n=7 Participants
|
731 Participants
n=5 Participants
|
|
Menopausal status
Postmenopausal
|
320 Participants
n=5 Participants
|
333 Participants
n=7 Participants
|
653 Participants
n=5 Participants
|
|
Histologic type
Invasive Ductal Carcinoma
|
567 Participants
n=5 Participants
|
589 Participants
n=7 Participants
|
1156 Participants
n=5 Participants
|
|
Histologic type
Invasive Lobular Carcinoma
|
66 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Histologic type
Other
|
36 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Histopathologic grade
Grade 1
|
100 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Histopathologic grade
Grade 2
|
307 Participants
n=5 Participants
|
338 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
|
Histopathologic grade
Grade 3
|
235 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Histopathologic grade
Unknown
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Breast surgery
Mastectomy
|
309 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
636 Participants
n=5 Participants
|
|
Breast surgery
Breast-conserving surgery
|
360 Participants
n=5 Participants
|
388 Participants
n=7 Participants
|
748 Participants
n=5 Participants
|
|
Axillary surgery
Lymphadenectomy
|
618 Participants
n=5 Participants
|
676 Participants
n=7 Participants
|
1294 Participants
n=5 Participants
|
|
Axillary surgery
Sentinel node biopsy
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Axillary surgery
Both
|
48 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Pathologic tumor size
pT1
|
339 Participants
n=5 Participants
|
327 Participants
n=7 Participants
|
666 Participants
n=5 Participants
|
|
Pathologic tumor size
pT2
|
294 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
645 Participants
n=5 Participants
|
|
Pathologic tumor size
pT3
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Regional lymph nodes
pN1
|
450 Participants
n=5 Participants
|
463 Participants
n=7 Participants
|
913 Participants
n=5 Participants
|
|
Regional lymph nodes
pN2
|
167 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
348 Participants
n=5 Participants
|
|
Regional lymph nodes
pN3
|
52 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Hormone receptor status
Negative
|
98 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
219 Participants
n=5 Participants
|
|
Hormone receptor status
Positive
|
571 Participants
n=5 Participants
|
594 Participants
n=7 Participants
|
1165 Participants
n=5 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) status
Negative
|
592 Participants
n=5 Participants
|
647 Participants
n=7 Participants
|
1239 Participants
n=5 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) status
Positive
|
77 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
Human epidermal growth factor receptor 2 (HER2) status
Unknown
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 5 yearsA participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
Outcome measures
| Measure |
Arm A: EC-T
n=669 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=715 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Number of Participants With Disease-free Survival (DFS) Event
|
127 Participants
|
170 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsA participant was considered to have had a OS event if patient died from any cause.
Outcome measures
| Measure |
Arm A: EC-T
n=669 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=715 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Number of Participants With Overall Survival (OS) Event
|
70 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 5 yearsSafety was assessed by standard clinical and laboratory tests, and were evaluated using NCI-CTC criteria v2.0
Outcome measures
| Measure |
Arm A: EC-T
n=667 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=711 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
The Number of Participants Who Experienced Adverse Events (AE)
|
665 Participants
|
699 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsPopulation: 360 patients completed a questionnaire specifically on hair loss 1-2 years after the end of chemotherapy
Hair loss was assessed by the quality of life of the patients through the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer 23 (EORTC QLQ-BR23) profile questionnaire, question 4. The quality of life of the patients was evaluated before each cycle and at the end of treatment. In questionnaire, raw scores range from 0 to 100 and a high score represents a high level of functioning or Health Related Quality of Life, excluding single-item scales in which high scores represent a high level of symptoms. A difference of 10 points on the scale over baseline value was classified as the minimum clinically meaningful change in both questionnaires.
Outcome measures
| Measure |
Arm A: EC-T
n=175 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=185 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss
Complete hair loss
|
165 Participants
|
176 Participants
|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss
Partial hair loss
|
9 Participants
|
8 Participants
|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss
No hair loss
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: 360 patients completed a questionnaire specifically on hair loss 1-2 years after the end of chemotherapy. Arm A: 174 and Arm B 184 patients suffer hair loss
Hair Loss Recovery was assessed by a specific Hair Toxicity Questionnaire were patients answered if the hair was less abundant than before, weaker than before or other. The questionnaire was evaluated up to two years after the end of chemotherapy.
Outcome measures
| Measure |
Arm A: EC-T
n=174 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=184 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss Recovery
Less abundant than before
|
52 Participants
|
26 Participants
|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss Recovery
Weaker than before
|
55 Participants
|
30 Participants
|
|
Quality of Life Questionnaire: Number of Participants With Hair Loss Recovery
Other
|
67 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: There is only information about take off the wig in 241 patients: Arm A: 111 and Arm B 130
Time to taking off the wig was assessed by a specific Hair Toxicity Questionnaire were patients answered when they stop to use the wig. The questionnaire was evaluated up to two years after the end of chemotherapy.
Outcome measures
| Measure |
Arm A: EC-T
n=111 Participants
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=130 Participants
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Quality of Life Questionnaire: Time to Taking Off the Wig
|
8.35 Months
Interval 0.62 to 61.35
|
6.03 Months
Interval 1.48 to 19.63
|
Adverse Events
Arm A: EC-T
Serious events: 111 serious events
Other events: 665 other events
Deaths: 70 deaths
Arm B: ET-X
Serious events: 138 serious events
Other events: 699 other events
Deaths: 83 deaths
Serious adverse events
| Measure |
Arm A: EC-T
n=669 participants at risk
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=715 participants at risk
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Infections and infestations
Febrile neutropenia
|
1.0%
7/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
General disorders
Fever
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
1.2%
8/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.42%
3/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Infections and infestations
Infection without neutropenia
|
1.0%
7/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.42%
3/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Investigations
Neutropenia
|
0.75%
5/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
General disorders
Fatigue
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Fistula anal
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Stomach flu
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Mucositis
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.30%
2/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.42%
3/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Abdominal pain and hematuria
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
Hand foot skin reaction
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Immune system disorders
Breast implant repeled
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Cardiac disorders
Heart Failure
|
0.45%
3/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Cardiac disorders
Thrombosis/embolism
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Nervous system disorders
Mood alteration-anxiety agitation
|
0.15%
1/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.00%
0/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Mucositis / Stomatitis
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Pancreatic adenocarcinoma
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
General disorders
Bone Fracture
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Cardiac disorders
Cardiac ischemia / infarction
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Infections and infestations
Catheter-related infection
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
CNS cerebrovascular ischemia
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Investigations
Creatinine
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/Pulmonary infiltrates
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic pain
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Biliary colic
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Vascular disorders
Bleeding
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Immune system disorders
Systemic lupus erythematosus
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
Epidermis necrosis
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.28%
2/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression disease, carcinomatosis meninges
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Injury, poisoning and procedural complications
Phenytoin poisoning interaction with capecitabine
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Renal and urinary disorders
Ureteral obstruction
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Cardiac disorders
Conduction abnormality/ Atrioventricular heart block
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Nervous system disorders
Confusion
|
0.00%
0/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
0.14%
1/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
Other adverse events
| Measure |
Arm A: EC-T
n=669 participants at risk
Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles.
Docetaxel
Epirubicin
Cyclophosphamide
|
Arm B: ET-X
n=715 participants at risk
Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles.
Docetaxel
Capecitabine
Epirubicin
|
|---|---|---|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES
|
16.1%
108/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
12.7%
91/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
18.8%
126/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
9.2%
66/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Reproductive system and breast disorders
IRREGULAR MENSES
|
23.9%
160/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
20.4%
146/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
HAND-FOOT SKIN REACTION
|
2.2%
15/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
23.6%
169/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
84.0%
562/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
79.6%
569/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
General disorders
FATIGUE
|
12.6%
84/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
10.3%
74/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Nausea
|
27.5%
184/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
22.5%
161/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
STOMATITIS/PHARYNGITIS (ORAL/PHARYNGEAL MUCOSITIS)
|
23.0%
154/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
16.1%
115/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
DIARRHEA
|
3.0%
20/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
10.2%
73/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
Diarrhea
|
11.4%
76/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
16.5%
118/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
15.7%
105/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
10.2%
73/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Skin and subcutaneous tissue disorders
NAIL CHANGES
|
14.9%
100/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
11.3%
81/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Hepatobiliary disorders
SGPT (ALT)
|
5.8%
39/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
13.1%
94/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
VOMITING
|
18.7%
125/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
17.1%
122/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
10.8%
72/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
4.8%
34/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.5%
70/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
8.3%
59/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Immune system disorders
INFECTION WITHOUT NEUTROPENIA
|
10.6%
71/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
8.5%
61/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
10.2%
68/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
8.7%
62/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
13.3%
89/669 • Through study treatment up to 30 days after last study dose, up to 7 months
|
5.9%
42/715 • Through study treatment up to 30 days after last study dose, up to 7 months
|
Additional Information
Scientific Director / Medical Lead / Project Manager
Spanish Breast Cancer Research Group
Phone: +34916592870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60