Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment
Study Details
Study Description
Brief Summary
This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:
-
TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
-
FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Detailed Description
Primary objective:
- To compare disease-free survival (DFS) after treatment with docetaxel in combination with doxorubicin and cyclophosphamide (TAC) to 5-Fluorouracil in combination with doxorubicin and cyclophosphamide (FAC) as adjuvant treatment of high risk operable breast cancer patients with negative axillary lymph nodes.
Secondary objectives:
-
To compare overall survival (OS) between the 2 above mentioned arms.
-
To compare toxicity and quality of life between the 2 above mentioned arms.
-
To evaluate pathologic markers for predicting efficacy (hormonal receptors and human epidermal growth factor receptor 2 (HER2) protein expression).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Arm A: FAC FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
Drug: 5-fluorouracil
Other Names:
Drug: Doxorubicin
Other Names:
Drug: Cyclophosphamide
Other Names:
|
Experimental: Arm B: TAC TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
Drug: Docetaxel
Other Names:
Drug: Doxorubicin
Other Names:
Drug: Cyclophosphamide
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Disease-free Survival (DFS) Events [10 years]
DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.
Secondary Outcome Measures
- Overall Survival (OS) [10 years]
OS was determined from the date of randomization until the date of death for any reason. OS is calculated from the date of randomization up to the first date of death by any cause.
- The Number of Participants Who Experienced Adverse Events (AE) [Through study treatment, and average of 4 months]
Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0.
- Best Score During Study for Global Health Status Scale [120 weeks]
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used. Questionnaires were self-administered to patients during the 14 days prior to randomisation baseline, at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study. The Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL.
- Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup [10 year]
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
- Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup [10 year]
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
- Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup [10 year]
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally.
- Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup [10 year]
Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Written informed consent
-
Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.
-
Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.
-
Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.
-
Patients without proven metastatic disease.
-
Estrogen and progesterone receptors performed on the primary tumour prior to randomization.
-
Age between 18 years and 70 years.
-
Karnofsky performance status index > 80 %.
-
Adequate hepatic, renal and heart functions.
-
Adequate hematology levels.
-
Negative pregnancy test
Exclusion Criteria:
-
Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
-
Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
-
Prior radiation therapy for breast cancer.
-
Bilateral invasive breast cancer.
-
Pregnant, or lactating patients.
-
Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .
-
Any T4 or N1-3 or M1 breast cancer.
-
Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.
-
Other serious illness or medical condition
-
Past or current history of neoplasm other than breast carcinoma.
-
Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.
-
Lobular carcinoma in-situ (LCIS) of the breast.
-
Chronic treatment with corticosteroids unless initiated > 6 months prior to study entry and at low dose
-
Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
-
Definite contraindications for the use of corticosteroids.
-
Concurrent treatment with other experimental drugs.
-
Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
-
Concurrent treatment with any other anti-cancer therapy.
-
Male patients.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Spanish Breast Cancer Research Group | San Sebastián de los Reyes | Madrid | Spain | 28700 |
Sponsors and Collaborators
- Spanish Breast Cancer Research Group
- Sanofi
Investigators
- Study Director: Study Director, Hospital Universitario San Carlos
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- GEICAM 9805
- TAX.ES1.301
Study Results
Participant Flow
Recruitment Details | For the different subsets ("Hormone-receptor Positive and HER2 PositiveStatus Subjects", "Hormonal Receptor Positive and HER2 Negative Subjects", etc.), were assessed by central determination, and no all patients had tumor sample available. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Period Title: Overall Study | ||
STARTED | 521 | 539 |
Hormone-receptor Positive and HER2 Positive Status Subjects | 28 | 30 |
Hormone-receptor Negative and HER2 Positive Status Subjects | 24 | 22 |
Hormone-receptor Positive and HER2 Negative Status Subjects | 209 | 220 |
Hormone-receptor Negative and HER2 Negative Status Subjects | 92 | 103 |
COMPLETED | 519 | 528 |
NOT COMPLETED | 2 | 11 |
Baseline Characteristics
Arm/Group Title | Arm A: FAC | Arm B: TAC | Total |
---|---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide | Total of all reporting groups |
Overall Participants | 521 | 539 | 1060 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
49
|
50
|
49
|
Sex: Female, Male (Count of Participants) | |||
Female |
521
100%
|
539
100%
|
1060
100%
|
Male |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (participants) [Number] | |||
Spain |
475
91.2%
|
487
90.4%
|
962
90.8%
|
Germany |
26
5%
|
30
5.6%
|
56
5.3%
|
Poland |
20
3.8%
|
22
4.1%
|
42
4%
|
Tumor size (Count of Participants) | |||
≤2 cm |
249
47.8%
|
285
52.9%
|
534
50.4%
|
>2 to 5 cm |
258
49.5%
|
241
44.7%
|
499
47.1%
|
>5 cm |
13
2.5%
|
13
2.4%
|
26
2.5%
|
Unknown |
1
0.2%
|
0
0%
|
1
0.1%
|
Tumor grade (Count of Participants) | |||
Grade 1 |
34
6.5%
|
38
7.1%
|
72
6.8%
|
Grade 2 |
230
44.1%
|
216
40.1%
|
446
42.1%
|
Grade 3 |
231
44.3%
|
259
48.1%
|
490
46.2%
|
Unknown |
26
5%
|
26
4.8%
|
52
4.9%
|
Menopausal status (Count of Participants) | |||
Premenopausal |
272
52.2%
|
285
52.9%
|
557
52.5%
|
Postmenopausal |
249
47.8%
|
254
47.1%
|
503
47.5%
|
Hormone-receptor status (Count of Participants) | |||
Positive |
349
67%
|
344
63.8%
|
693
65.4%
|
Negative |
170
32.6%
|
192
35.6%
|
362
34.2%
|
Unknown |
2
0.4%
|
3
0.6%
|
5
0.5%
|
Surgery (Count of Participants) | |||
Breast-conserving surgery: With radiation |
247
47.4%
|
287
53.2%
|
534
50.4%
|
Breast-conserving surgery: Without radiation |
24
4.6%
|
24
4.5%
|
48
4.5%
|
Mastectomy: With radiation |
20
3.8%
|
22
4.1%
|
42
4%
|
Mastectomy: Without radiation |
230
44.1%
|
206
38.2%
|
436
41.1%
|
Outcome Measures
Title | Disease-free Survival (DFS) Events |
---|---|
Description | DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death. |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 521 | 539 |
Number [events] |
127
|
112
|
Title | Overall Survival (OS) |
---|---|
Description | OS was determined from the date of randomization until the date of death for any reason. OS is calculated from the date of randomization up to the first date of death by any cause. |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 521 | 539 |
Number [Participants with mortality event] |
57
10.9%
|
53
9.8%
|
Title | The Number of Participants Who Experienced Adverse Events (AE) |
---|---|
Description | Safety was assessed by standard clinical and laboratory tests (haematology, serum chemistry). AE grade were defined by the NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 1.0. |
Time Frame | Through study treatment, and average of 4 months |
Outcome Measure Data
Analysis Population Description |
---|
The safety analysis was conducted on all patients who started at least one infusion of the study treatment (Arm A 519, and Arm B 532). |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 519 | 532 |
Number patients with One AE |
519
99.6%
|
532
98.7%
|
One G3-4 or severe treatment-emergent AE |
88
16.9%
|
151
28%
|
One serious treatment-emergent AE |
22
4.2%
|
119
22.1%
|
One serious G3-4 treatment-emergent AE |
10
1.9%
|
55
10.2%
|
Number of patients discontinued due to AE |
4
0.8%
|
25
4.6%
|
Number patients death due to AE |
0
0%
|
1
0.2%
|
Title | Best Score During Study for Global Health Status Scale |
---|---|
Description | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was used. Questionnaires were self-administered to patients during the 14 days prior to randomisation baseline, at six prospective time points corresponding to chemotherapy cycles, with the time window related to each chemotherapy cycle defined as the period between the day following the first chemotherapy dose of the corresponding cycle and the day of the first dose of the following cycle, and then at 44, 68 and 120 weeks of the study. The Global Health Status Scale has been used, which is calculated with questions 29 and 30 from the EORTC QLQ-C30. From this scale, the best score is the highest score observed during study (of all the questionnaires completed by patient). In this scale, scores range from 0 to 100 and a high score represents a high level of functioning or HRQoL. |
Time Frame | 120 weeks |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 519 | 532 |
Mean (Standard Deviation) [score on a scale] |
79.30
(17.64)
|
77.78
(18.87)
|
Title | Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup |
---|---|
Description | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. |
Time Frame | 10 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 28 | 30 |
Number [events] |
6
|
6
|
Title | Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup |
---|---|
Description | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. |
Time Frame | 10 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 209 | 220 |
Number [events] |
50
|
37
|
Title | Disease Free Survival in Hormonal Receptor Negative and HER2 Positive Subgroup |
---|---|
Description | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. |
Time Frame | 10 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 24 | 22 |
Number [events] |
6
|
5
|
Title | Disease Free Survival in Hormonal Receptor Negative and HER2 Negative Subgroup |
---|---|
Description | Hormone-receptor status and HER2 receptor status was analysed in Paraffin-embedded tumor samples obtained at the time of surgery, and were processed centrally. Disease-Free Survival (DFS) is defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first. |
Time Frame | 10 year |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Arm A: FAC | Arm B: TAC |
---|---|---|
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide |
Measure Participants | 92 | 103 |
Number [events] |
29
|
28
|
Adverse Events
Time Frame | Through study treatment, an average of 18 weeks | |||
---|---|---|---|---|
Adverse Event Reporting Description | The safety analysis were conducted on all patients who started at least one infusion of the study treatment. | |||
Arm/Group Title | Arm A: FAC | Arm B: TAC | ||
Arm/Group Description | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv 5-fluorouracil Doxorubicin Cyclophosphamide | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv Docetaxel Doxorubicin Cyclophosphamide | ||
All Cause Mortality |
||||
Arm A: FAC | Arm B: TAC | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 57/519 (11%) | 53/532 (10%) | ||
Serious Adverse Events |
||||
Arm A: FAC | Arm B: TAC | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 21/519 (4%) | 119/532 (22.4%) | ||
Blood and lymphatic system disorders | ||||
Anaemia | 1/519 (0.2%) | 1/532 (0.2%) | ||
Blood bilirubin | 0/519 (0%) | 1/532 (0.2%) | ||
Leukopenia | 0/519 (0%) | 1/532 (0.2%) | ||
Neutropenia | 1/519 (0.2%) | 5/532 (0.9%) | ||
Cardiac disorders | ||||
Arrhythmia | 0/519 (0%) | 1/532 (0.2%) | ||
Carotid artery thrombosis | 1/519 (0.2%) | 0/532 (0%) | ||
Ear and labyrinth disorders | ||||
Ear infection | 0/519 (0%) | 1/532 (0.2%) | ||
Eye disorders | ||||
Conjunctivitis | 0/519 (0%) | 1/532 (0.2%) | ||
Gastrointestinal disorders | ||||
Abdominal pain | 1/519 (0.2%) | 1/532 (0.2%) | ||
Anal fissure | 0/519 (0%) | 1/532 (0.2%) | ||
Constipation | 0/519 (0%) | 1/532 (0.2%) | ||
Diarrhoea | 1/519 (0.2%) | 6/532 (1.1%) | ||
Dyspepsia | 0/519 (0%) | 1/532 (0.2%) | ||
Nausea | 1/519 (0.2%) | 4/532 (0.8%) | ||
General disorders | ||||
Asthenia | 0/519 (0%) | 1/532 (0.2%) | ||
Fever in absence of infection | 12/519 (2.3%) | 68/532 (12.8%) | ||
General physical health deterioration | 0/519 (0%) | 1/532 (0.2%) | ||
Pyrexia | 0/519 (0%) | 2/532 (0.4%) | ||
Infections and infestations | ||||
Cellulitis | 0/519 (0%) | 1/532 (0.2%) | ||
Device related infection | 0/519 (0%) | 1/532 (0.2%) | ||
Localised infection | 0/519 (0%) | 1/532 (0.2%) | ||
Postoperative wound infection | 0/519 (0%) | 1/532 (0.2%) | ||
Skin infection | 0/519 (0%) | 2/532 (0.4%) | ||
Wound infection | 0/519 (0%) | 1/532 (0.2%) | ||
Investigations | ||||
Febrile neutropenia | 0/519 (0%) | 3/532 (0.6%) | ||
Metabolism and nutrition disorders | ||||
Pancreatitis | 0/519 (0%) | 1/532 (0.2%) | ||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
Disease progression | 0/519 (0%) | 1/532 (0.2%) | ||
Nervous system disorders | ||||
Hypersensitivity | 0/519 (0%) | 1/532 (0.2%) | ||
Reproductive system and breast disorders | ||||
Breast cyst | 0/519 (0%) | 1/532 (0.2%) | ||
Breast infection | 1/519 (0.2%) | 0/532 (0%) | ||
Breast haematoma | 1/519 (0.2%) | 0/532 (0%) | ||
Menorrhagia | 0/519 (0%) | 1/532 (0.2%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Bronchopneumonia | 0/519 (0%) | 1/532 (0.2%) | ||
Cough | 0/519 (0%) | 1/532 (0.2%) | ||
Respiratory tract infection | 0/519 (0%) | 1/532 (0.2%) | ||
Tonsillitis | 0/519 (0%) | 1/532 (0.2%) | ||
Skin and subcutaneous tissue disorders | ||||
Erysipelas | 0/519 (0%) | 1/532 (0.2%) | ||
Vascular disorders | ||||
Deep vein thrombosis | 1/519 (0.2%) | 0/532 (0%) | ||
Oedema peripheral | 0/519 (0%) | 1/532 (0.2%) | ||
Thrombosis | 0/519 (0%) | 1/532 (0.2%) | ||
Other (Not Including Serious) Adverse Events |
||||
Arm A: FAC | Arm B: TAC | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 519/519 (100%) | 532/532 (100%) | ||
Blood and lymphatic system disorders | ||||
Neutropenia | 9/519 (1.7%) | 33/532 (6.2%) | ||
Thrombocytopenia | 2/519 (0.4%) | 2/532 (0.4%) | ||
Cardiac disorders | ||||
Arrhythmia | 6/519 (1.2%) | 12/532 (2.3%) | ||
Cardiac failure | 0/519 (0%) | 1/532 (0.2%) | ||
Eye disorders | ||||
Conjunctivitis | 104/519 (20%) | 108/532 (20.3%) | ||
Lacrimation increased | 18/519 (3.5%) | 24/532 (4.5%) | ||
Gastrointestinal disorders | ||||
Nausea | 387/519 (74.6%) | 379/532 (71.2%) | ||
Stomatitis | 265/519 (51.1%) | 292/532 (54.9%) | ||
Vomiting | 294/519 (56.6%) | 292/532 (54.9%) | ||
Diarrhoea | 70/519 (13.5%) | 147/532 (27.6%) | ||
Abdominal pain upper | 71/519 (13.7%) | 88/532 (16.5%) | ||
Dyspepsia | 50/519 (9.6%) | 57/532 (10.7%) | ||
Haemorrhoids | 6/519 (1.2%) | 11/532 (2.1%) | ||
Flatulence | 2/519 (0.4%) | 6/532 (1.1%) | ||
Anal abscess | 0/519 (0%) | 1/532 (0.2%) | ||
General disorders | ||||
Asthenia | 305/519 (58.8%) | 387/532 (72.7%) | ||
Pain | 80/519 (15.4%) | 118/532 (22.2%) | ||
Pyrexia | 46/519 (8.9%) | 90/532 (16.9%) | ||
Decreased appetite | 69/519 (13.3%) | 88/532 (16.5%) | ||
Weight increased | 10/519 (1.9%) | 29/532 (5.5%) | ||
Bone pain | 1/519 (0.2%) | 18/532 (3.4%) | ||
Back pain | 6/519 (1.2%) | 17/532 (3.2%) | ||
Fatigue | 7/519 (1.3%) | 4/532 (0.8%) | ||
Hyperhidrosis | 1/519 (0.2%) | 3/532 (0.6%) | ||
Infections and infestations | ||||
Urinary tract infection | 10/519 (1.9%) | 11/532 (2.1%) | ||
Vaginal infection | 1/519 (0.2%) | 5/532 (0.9%) | ||
Infection | 0/519 (0%) | 3/532 (0.6%) | ||
Herpes zoster | 3/519 (0.6%) | 2/532 (0.4%) | ||
Musculoskeletal and connective tissue disorders | ||||
Myalgia | 15/519 (2.9%) | 123/532 (23.1%) | ||
Arthralgia | 30/519 (5.8%) | 108/532 (20.3%) | ||
Nervous system disorders | ||||
Dysgeusia | 71/519 (13.7%) | 85/532 (16%) | ||
Peripheral Sensory Neuropathy | 38/519 (7.3%) | 83/532 (15.6%) | ||
Peripheral motor neuropathy | 2/519 (0.4%) | 18/532 (3.4%) | ||
Photophobia | 1/519 (0.2%) | 6/532 (1.1%) | ||
Visual impairment | 1/519 (0.2%) | 3/532 (0.6%) | ||
Psychiatric disorders | ||||
Insomnia | 24/519 (4.6%) | 27/532 (5.1%) | ||
Affective disorder | 28/519 (5.4%) | 25/532 (4.7%) | ||
Reproductive system and breast disorders | ||||
Amenorrhoea | 70/519 (13.5%) | 121/532 (22.7%) | ||
Menstruation irregular | 90/519 (17.3%) | 103/532 (19.4%) | ||
Hot flush | 54/519 (10.4%) | 74/532 (13.9%) | ||
Metrorrhagia | 2/519 (0.4%) | 4/532 (0.8%) | ||
Vaginal haemorrhage | 1/519 (0.2%) | 3/532 (0.6%) | ||
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 24/519 (4.6%) | 26/532 (4.9%) | ||
Lung disorder | 14/519 (2.7%) | 17/532 (3.2%) | ||
Dyspnoea | 3/519 (0.6%) | 12/532 (2.3%) | ||
Chest pain | 6/519 (1.2%) | 7/532 (1.3%) | ||
Pleural effusion | 0/519 (0%) | 1/532 (0.2%) | ||
Pulmonary embolism | 1/519 (0.2%) | 0/532 (0%) | ||
Skin and subcutaneous tissue disorders | ||||
Alopecia | 508/519 (97.9%) | 514/532 (96.6%) | ||
Nail disorder | 77/519 (14.8%) | 102/532 (19.2%) | ||
Skin disorder | 51/519 (9.8%) | 96/532 (18%) | ||
Erythema | 5/519 (1%) | 10/532 (1.9%) | ||
Pigmentation disorder | 0/519 (0%) | 2/532 (0.4%) | ||
Dry skin | 2/519 (0.4%) | 1/532 (0.2%) | ||
Vascular disorders | ||||
Oedema peripheral | 19/519 (3.7%) | 101/532 (19%) | ||
Lymphoedema | 3/519 (0.6%) | 13/532 (2.4%) | ||
Varicose vein | 0/519 (0%) | 1/532 (0.2%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Scientific Director / Medical Lead / Project Manager |
---|---|
Organization | Spanish Breast Cancer Research Group |
Phone | +34916592870 |
geicam@geicam.org |
- GEICAM 9805
- TAX.ES1.301