Trial Outcomes & Findings for Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients (NCT NCT00130533)
NCT ID: NCT00130533
Last Updated: 2023-03-31
Results Overview
DFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
876 participants
Primary outcome timeframe
5 years
Results posted on
2023-03-31
Participant Flow
Between October 2006 and September 2011, 876 patients were recruited, across 80 institutions in 8 countries (Spain, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, and Venezuela)
Participant milestones
| Measure |
Xeloda (Capecitabine)
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
Observation. No intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
448
|
428
|
|
Overall Study
COMPLETED
|
337
|
398
|
|
Overall Study
NOT COMPLETED
|
111
|
30
|
Reasons for withdrawal
| Measure |
Xeloda (Capecitabine)
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
Observation. No intervention.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
33
|
6
|
|
Overall Study
Adverse Event
|
34
|
1
|
|
Overall Study
Disease relapse
|
9
|
13
|
|
Overall Study
Interruption of treatment > 3 weeks
|
11
|
0
|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Protocol Violation
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Sponsor´s decision
|
2
|
0
|
|
Overall Study
Second Primary Malignancy
|
0
|
1
|
|
Overall Study
Other
|
12
|
5
|
Baseline Characteristics
Maintenance Treatment With Capecitabine Versus Observation in Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Xeloda (Capecitabine)
n=448 Participants
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=428 Participants
Observation. No intervention.
|
Total
n=876 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=99 Participants
|
49 years
n=107 Participants
|
49 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
448 Participants
n=99 Participants
|
428 Participants
n=107 Participants
|
876 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
313 Participants
n=99 Participants
|
309 Participants
n=107 Participants
|
622 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
107 Participants
n=99 Participants
|
97 Participants
n=107 Participants
|
204 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
16 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
272 participants
n=99 Participants
|
260 participants
n=107 Participants
|
532 participants
n=206 Participants
|
|
Region of Enrollment
Brazil
|
71 participants
n=99 Participants
|
68 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
Region of Enrollment
Mexico
|
61 participants
n=99 Participants
|
52 participants
n=107 Participants
|
113 participants
n=206 Participants
|
|
Region of Enrollment
Chile
|
19 participants
n=99 Participants
|
23 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Region of Enrollment
Peru
|
7 participants
n=99 Participants
|
12 participants
n=107 Participants
|
19 participants
n=206 Participants
|
|
Region of Enrollment
Ecuador
|
9 participants
n=99 Participants
|
9 participants
n=107 Participants
|
18 participants
n=206 Participants
|
|
Region of Enrollment
Colombia
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Region of Enrollment
Venezuela
|
3 participants
n=99 Participants
|
1 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Karnofsky Index Performance Status
80
|
8 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Karnofsky Index Performance Status
90
|
57 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Karnofsky Index Performance Status
100
|
383 Participants
n=99 Participants
|
344 Participants
n=107 Participants
|
727 Participants
n=206 Participants
|
|
Menopausal status at diagnosis
Premenopausal
|
136 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
276 Participants
n=206 Participants
|
|
Menopausal status at diagnosis
Postmenopausal
|
312 Participants
n=99 Participants
|
288 Participants
n=107 Participants
|
600 Participants
n=206 Participants
|
|
Histologic type
Invasive ductal carcinoma
|
395 Participants
n=99 Participants
|
369 Participants
n=107 Participants
|
764 Participants
n=206 Participants
|
|
Histologic type
Invasive lobular carcinoma
|
9 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Histologic type
Other
|
44 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Histologic grade
Grade 1
|
15 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Histologic grade
Grade 2
|
82 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
163 Participants
n=206 Participants
|
|
Histologic grade
Grade 3
|
323 Participants
n=99 Participants
|
299 Participants
n=107 Participants
|
622 Participants
n=206 Participants
|
|
Histologic grade
Unknown
|
28 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Phenotype by immunohistochemistry (IHC)
Basal
|
319 Participants
n=99 Participants
|
309 Participants
n=107 Participants
|
628 Participants
n=206 Participants
|
|
Phenotype by immunohistochemistry (IHC)
Non-basal
|
129 Participants
n=99 Participants
|
119 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Stage at diagnosis
Stage I
|
62 Participants
n=99 Participants
|
74 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Stage at diagnosis
Stage II
|
270 Participants
n=99 Participants
|
271 Participants
n=107 Participants
|
541 Participants
n=206 Participants
|
|
Stage at diagnosis
Stage III
|
106 Participants
n=99 Participants
|
80 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
|
Stage at diagnosis
Unknown
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Nodal status
Negative
|
244 Participants
n=99 Participants
|
242 Participants
n=107 Participants
|
486 Participants
n=206 Participants
|
|
Nodal status
1-3 positive nodes
|
121 Participants
n=99 Participants
|
124 Participants
n=107 Participants
|
245 Participants
n=206 Participants
|
|
Nodal status
≥4 positive nodes
|
77 Participants
n=99 Participants
|
61 Participants
n=107 Participants
|
138 Participants
n=206 Participants
|
|
Nodal status
Missing data
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Type of prior Chemotherapy
Adjuvant (only)
|
353 Participants
n=99 Participants
|
352 Participants
n=107 Participants
|
705 Participants
n=206 Participants
|
|
Type of prior Chemotherapy
Neoadjuvant (+/- adjuvant)
|
89 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Type of prior Chemotherapy
Missing data
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Chemotherapy regimens
Anthracyclines-based
|
147 Participants
n=99 Participants
|
138 Participants
n=107 Participants
|
285 Participants
n=206 Participants
|
|
Chemotherapy regimens
Anthracyclines and taxanes-based
|
301 Participants
n=99 Participants
|
290 Participants
n=107 Participants
|
591 Participants
n=206 Participants
|
|
Breast surgery
Conservative
|
237 Participants
n=99 Participants
|
242 Participants
n=107 Participants
|
479 Participants
n=206 Participants
|
|
Breast surgery
Mastectomy
|
205 Participants
n=99 Participants
|
185 Participants
n=107 Participants
|
390 Participants
n=206 Participants
|
|
Breast surgery
Missing data
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Axillary surgery
sentinel lymph node biopsy (SLNB)
|
99 Participants
n=99 Participants
|
122 Participants
n=107 Participants
|
221 Participants
n=206 Participants
|
|
Axillary surgery
axillary lymph node dissection +/- SLNB
|
349 Participants
n=99 Participants
|
306 Participants
n=107 Participants
|
655 Participants
n=206 Participants
|
|
Radiation therapy
Yes
|
352 Participants
n=99 Participants
|
346 Participants
n=107 Participants
|
698 Participants
n=206 Participants
|
|
Radiation therapy
No
|
91 Participants
n=99 Participants
|
81 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Radiation therapy
Unknown
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 yearsDFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=448 Participants
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=428 Participants
Observation. No intervention.
|
|---|---|---|
|
Disease Free Survival (DFS) Events
|
105 Participants
|
120 Participants
|
SECONDARY outcome
Timeframe: 5 yearsDFS was measured from the date of randomization assignment in the intent to treat (ITT) population to loco-regional or distant recurrence, second primary malignancy or death date, whichever occurred first.
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=105 Participants
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=120 Participants
Observation. No intervention.
|
|---|---|---|
|
Disease Free Survival (DFS) Events by Phenotype
Basal Phenotype
|
84 Participants
|
86 Participants
|
|
Disease Free Survival (DFS) Events by Phenotype
Non basal Phenotype
|
21 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 5 yearsOS event is defined as the death from any cause.
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=448 Participants
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=428 Participants
Observation. No intervention.
|
|---|---|---|
|
Overall Survival (OS) Event
|
71 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: The analysis of toxicity was made in all study patients who had received at least 1 treatment cycle, or who had completed the observation period equivalent to 1 cycle.
Safety will be 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).
Outcome measures
| Measure |
Xeloda (Capecitabine)
n=436 Participants
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=425 Participants
Observation. No intervention.
|
|---|---|---|
|
The Number of Participants Who Experienced Adverse Events (AE)
|
416 Participants
|
271 Participants
|
Adverse Events
Xeloda (Capecitabine)
Serious events: 23 serious events
Other events: 416 other events
Deaths: 71 deaths
Observation
Serious events: 6 serious events
Other events: 271 other events
Deaths: 73 deaths
Serious adverse events
| Measure |
Xeloda (Capecitabine)
n=436 participants at risk
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=425 participants at risk
Observation. No intervention.
|
|---|---|---|
|
Gastrointestinal disorders
Gastroenteritis and renal insuficience
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Cardiac disorders
Supraventricular arrhythmia NOS
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.92%
4/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
General disorders
Worsening of depressive syndrome
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic pain grade 2, disnea G-1
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
Infections and infestations
Infection with normal ANC ( Urinary)
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Blood and lymphatic system disorders
Neutropenia G 3; Leucopenia G2
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.46%
2/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Nervous system disorders
Hand-foot skin reaction
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.46%
2/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Renal and urinary disorders
Right renal colic
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Pregnancy, puerperium and perinatal conditions
Positive pregnant test performed
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
Gastrointestinal disorders
Mucositis Oral cavity and Pharynx
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Cardiac disorders
Heart failure
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Thorax and left arm pain
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Cardiac disorders
Infarction and cardiac arrest
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
Infections and infestations
Infection with unknown ANC pulmonary/upper respiratory - lung (pneumonia)
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
Vascular disorders
Thrombosis/thrombus/embolism: venous thrombosis
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Cardiac disorders
Ischemia cardiac/Infarction
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Surgical and medical procedures
Axillary nodular resection
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Cardiac disorders
Coronary vasospam
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Gastrointestinal disorders
Diarrhea grade 2, Vomiting grade 2, Septic shock grade 5
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Showed lumbar column fracture(L4)
|
0.00%
0/436 • 5 years
|
0.24%
1/425 • 5 years
|
|
General disorders
Dehydration
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
General disorders
Febrile neutropenia, Diarrhea, Hand foot skin reaction, Acute renal failure
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Infections and infestations
Pneumonia
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Gastrointestinal disorders
Ulcer gastric
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Blood and lymphatic system disorders
Hyperbilirrubinemia
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
Other adverse events
| Measure |
Xeloda (Capecitabine)
n=436 participants at risk
1000 mgrs/m2 twice a day, tablets, 8 cycles
Capecitabine
|
Observation
n=425 participants at risk
Observation. No intervention.
|
|---|---|---|
|
Blood and lymphatic system disorders
LEUKOCYTES (TOTAL WBC)
|
12.4%
54/436 • 5 years
|
2.8%
12/425 • 5 years
|
|
Blood and lymphatic system disorders
NEUTROPHILS/GRANULOCYTES
|
15.4%
67/436 • 5 years
|
8.9%
38/425 • 5 years
|
|
General disorders
FATIGUE
|
25.5%
111/436 • 5 years
|
8.9%
38/425 • 5 years
|
|
Blood and lymphatic system disorders
HEMOGLOBIN
|
20.0%
87/436 • 5 years
|
6.4%
27/425 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
19.3%
84/436 • 5 years
|
1.4%
6/425 • 5 years
|
|
Metabolism and nutrition disorders
ALT, SGPT
|
15.8%
69/436 • 5 years
|
6.4%
27/425 • 5 years
|
|
Nervous system disorders
NEUROPATHY: SENSORY
|
11.5%
50/436 • 5 years
|
4.9%
21/425 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
9.2%
40/436 • 5 years
|
6.1%
26/425 • 5 years
|
|
Metabolism and nutrition disorders
BILIRUBIN
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Gastrointestinal disorders
DIARRHEA
|
21.6%
94/436 • 5 years
|
0.94%
4/425 • 5 years
|
|
Metabolism and nutrition disorders
AST, SGOT
|
17.0%
74/436 • 5 years
|
5.4%
23/425 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.23%
1/436 • 5 years
|
0.00%
0/425 • 5 years
|
|
Metabolism and nutrition disorders
URIC ACID, SERUM-HIGH
|
1.6%
7/436 • 5 years
|
0.94%
4/425 • 5 years
|
|
Reproductive system and breast disorders
IRREGULAR MENSES
|
1.1%
5/436 • 5 years
|
1.4%
6/425 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH: HAND-FOOT SKIN REACTION
|
26.4%
115/436 • 5 years
|
0.47%
2/425 • 5 years
|
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