Trial Outcomes & Findings for Standard Versus Continuous Capecitabine in Advanced Breast Cancer (NCT NCT00418028)
NCT ID: NCT00418028
Last Updated: 2019-02-22
Results Overview
Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
195 participants
Primary outcome timeframe
After 1 year from the treatment start day.
Results posted on
2019-02-22
Participant Flow
Between November 2004 and August 2010, 195 patients were randomly assigned to Cint (97) and Ccont (98) in 13 GEICAM sites in Spain.
Participant milestones
| Measure |
Arm A (Cint)
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
Arm B (Ccont)
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
98
|
|
Overall Study
COMPLETED
|
95
|
97
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Standard Versus Continuous Capecitabine in Advanced Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm A (Cint)
n=97 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
Arm B (Ccont)
n=98 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
55 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
42 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Age, Continuous
|
61.07 years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
58.59 years
STANDARD_DEVIATION 11.66 • n=7 Participants
|
59.82 years
STANDARD_DEVIATION 12.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
195 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
|
97 participants
n=5 Participants
|
98 participants
n=7 Participants
|
195 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After 1 year from the treatment start day.Population: A total of 192 patients (95 in Arm A and 97 in Arm B) were considered for this analysis but 36 were censored (23 in Arm A and 13 in Arm B). Patients censored are those that did not progress or die due to progressive disease during the study treatment.
Time to Progression (TTP) is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies due to progressive disease. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0).
Outcome measures
| Measure |
Arm A (Cint)
n=72 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=84 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Time to Progression
|
8.68 months
Interval 6.55 to 11.05
|
6.84 months
Interval 6.02 to 8.06
|
SECONDARY outcome
Timeframe: Through the study treatment, an average of 5 months.Population: There were 95 patients in Arm A and 97 patients in Arm B. There were 13 patients without response evaluation (9 in Arm A and 4 in Arm B).
Response was evaluated using the Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), every 3 cycles of chemotherapy (each cycle lasts 3 weeks) and at the end of treatment (at 21 weeks from the start of treatment).
Outcome measures
| Measure |
Arm A (Cint)
n=86 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=93 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Response Rate
|
30 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first, assessed up to 72 weeks.Population: From 192 patients (95 in Arm A and 97 in Arm B), 61 patients had Complete Response or Partial Response (30 in Arm A and 31 in Arm B).
Response duration is computed for all patients with Partial Response or Complete Response, during the treatment period, as the time from the moment the Partial or Complete Response is reported to the date the patient Progresses or Dies, whichever happens first. A patient is censored if she does not progress or die. In these cases Response duration is computed as the time from the moment the Partial or Complete Response is reported to the last contact date.
Outcome measures
| Measure |
Arm A (Cint)
n=30 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=31 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Response Duration
|
10.07 Months
Interval 7.96 to 16.71
|
7.20 Months
Interval 4.11 to 12.7
|
SECONDARY outcome
Timeframe: Time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria, assessed up to 72 months.Population: This outcome only was analyzed in the Per Protocol Population (182 patients).
Time to treatment failure (TTF) is defined as the time (in months) from the moment the patient starts the study treatment to the end of treatment date (due to death, progressive disease, adverse events, patient's decision or investigator criteria. If a patient did not end the treatment, it is censored. The censoring date is the date of the last dose received.
Outcome measures
| Measure |
Arm A (Cint)
n=90 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=92 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Time to Treatment Failure
|
5.41 Months
Interval 4.34 to 8.03
|
5.87 Months
Interval 3.55 to 7.14
|
SECONDARY outcome
Timeframe: Time to survival is the number of months from the study treatment start date to the date of death, assessed up to 100 months.An event is defined as death. A patient is censored if she does not die. The censoring date is last contact date.
Outcome measures
| Measure |
Arm A (Cint)
n=95 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=97 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Overall Survival
|
27.34 Months
Interval 22.4 to 32.11
|
24.11 Months
Interval 18.16 to 33.06
|
SECONDARY outcome
Timeframe: Months from "CR","PR" or "SD" (the first one) until Progression date, new treatment or last contact date.Population: Only 179 patients had tumor evaluation data.
A patient experiences a Clinical Benefit if the following is satisfied: Criterion: The patient has "Complete response", "Partial Response" or "Stable Disease" and it continues during more than 3 months.
Outcome measures
| Measure |
Arm A (Cint)
n=86 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=93 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Clinical Benefit
|
56 Participants
|
56 Participants
|
SECONDARY outcome
Timeframe: Time (in months) from the moment the patient starts the study treatment to the date of progressive disease assessed up to 84 months.Progression Free Survival is defined as the time (in months) from the moment the patient starts the study treatment to the date of progressive disease. That is, a patient has an event is she progresses or dies for any reason.
Outcome measures
| Measure |
Arm A (Cint)
n=95 Participants
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity.
|
Arm B (Ccont)
n=97 Participants
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity.
|
|---|---|---|
|
Progression Free Survival
|
8.52 Months
Interval 5.66 to 10.2
|
6.84 Months
Interval 6.02 to 8.06
|
Adverse Events
A Cint
Serious events: 13 serious events
Other events: 81 other events
Deaths: 0 deaths
B Ccont
Serious events: 4 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
A Cint
n=95 participants at risk
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
B Ccont
n=97 participants at risk
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
6.3%
6/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Infections and infestations
Febrile neutropenia
|
2.1%
2/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Gastrointestinal disorders
Obstruction
|
1.1%
1/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Cardiac disorders
Ventricular arrhythmia
|
1.1%
1/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
1.1%
1/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
1.1%
1/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
1.0%
1/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
1.0%
1/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
1.0%
1/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
1.0%
1/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Nervous system disorders
Dizziness
|
1.1%
1/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
Other adverse events
| Measure |
A Cint
n=95 participants at risk
Capecitabine will be administered orally at a dose of 1250 mg/m2 twice-daily (in the morning and in the evening, the equivalent of a total daily dose of 2500 mg/m2) for 14 days, in 3 week cycles with a resting period of 7 days,until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
drug: capecitabine: 800 mg/m2 twice a day orally continuous administration until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
B Ccont
n=97 participants at risk
Capecitabine 800 mg/m2 orally twice-daily (in the morning and in the evening the equivalent of one dose of 1600 mg/m2) for 21 days, in 3 week cycles without resting period, until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
capecitabine: 1250 mg/m2 twice a day orally x 14 days every 3 weeks until disease progression or severe toxicity. Dose adjustments were made in patients with grade 3 or greater diarrhea or hand and food syndrome.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
41.1%
39/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
42.3%
41/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Blood and lymphatic system disorders
Grade 3-4 Thrombocytopenia
|
3.2%
3/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
0.00%
0/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Blood and lymphatic system disorders
Grade 3-4 Neutropenia
|
9.5%
9/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
2.1%
2/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Gastrointestinal disorders
Grade 3-4 Diarrhea
|
20.0%
19/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
6.2%
6/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
11.6%
11/95 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
2.1%
2/97 • During the study treatment (Metastatic Breast Cancer patients), up to 30 weeks approximately.
|
Additional Information
The Oncologist 2015;20:1-2 http://www.theoncologist.com/ Scientific Director and CEO
GEICAM (Grupo Español de Investigación en Cancer de Mama)
Phone: +34916592870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60