A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer

A Randomized, Open-label Study of the Effect of Adjuvant Therapy With Adriamycin Plus Cytoxan Followed by Taxotere or Taxotere Plus Xeloda on Overall Survival in Female Patients With High-risk Breast Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00089479

Enrollment

2611

Registered

2004-08-06

Start date

2002-08-31

Completion date

2012-05-31

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer. Following 4 cycles of Adriamycin and Cytoxan, patients will be randomized to receive either 1)Taxotere 75mg/m2 iv on day 1 and Xeloda 825mg/m2 po bid on days 1-14 of each 3 week cycle or 2) Taxotere 100mg/m2 iv alone on day 1 of each 3 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Interventions

DRUGcapecitabine [Xeloda]

825mg/m2 po bid on days 1-14 of each 3 week cycle

DRUGTaxotere

75mg/m2 iv on day 1 of each 3 week cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* female patients 18-70 years of age; * adenocarcinoma of the breast; * previous invasive breast cancer if diagnosed \>5 years before entering study; * no evidence of metastatic disease.

Exclusion criteria

* history of severe hypersensitivity reaction to Taxotere; * previous treatment with anthracycline, anthracenedione (mitoxantrone), or taxane; * treatment with fluoropyrimidine (5-fluorouracil) within the last 5 years.

Design outcomes

Primary

Measure	Time frame	Description
Disease Free Survival [Number of Events]	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Number of patients with/without recurrence of breast cancer, or death due to any cause.
Disease Free Survival [Time to Event]	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.

Secondary

Measure	Time frame	Description
Breast Cancer Free Survival [Number of Events]	Time from the date of randomization to event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years .	Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer.
Breast Cancer Free Survival [Time to Event]	Time from the date of randomization to death, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Breast cancer-free survival was measured as time from the date of randomization to the date of recurrence of breast cancer, new primary breast cancer, or death related to the chemotherapy administered or due to breast cancer. Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Disease Free Survival Including New Primary Breast Cancer as Event [Number of Events]	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Number of patients with/without recurrence of breast cancer, new primary breast cancer, or death due to any cause.
Overall Survival [Number of Events]	Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.	Number of patients who died/were alive.
Disease Free Survival Including Any New Cancer as Event [Number of Events]	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Number of patients with/without recurrence of breast cancer, any new cancer, or death due to any cause.
Disease Free Survival Including Any New Cancer as Event [Time to Event]	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Time from the date of randomization until the date of first event (recurrence of breast cancer, any new cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Disease Free Survival Including New Primary Breast Cancer as Event [Time to Event	Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.	Time from the date of randomization until the date of first event (recurrence of breast cancer, new primary breast cancer, or death due to any cause). Patients without event at the time of the analysis were censored using the date they were last known to be recurrent disease free.
Overall Survival [Time to Event]	Time from the date of randomization to the date of death, or date last known to be alive. Patients were followed for an average of 5 years.	Overall survival was measured as the time from the date of randomization to the date of death. Patients still alive at the time of the analysis were censored using the date they were last known to be alive.

Countries

United States

Participant flow

Participants by arm

Arm	Count
AC Then T Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m\^2; repeat every 3 weeks for 4 cycles	1,304
AC Then XT Adriamycin 60 mg/m\^2 iv plus Cytoxan 600 mg/m\^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m\^2 po (bid) \[total daily dose is 1650 mg/m\^2\] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m\^2 iv every 3 weeks for 4 cycles	1,307
Total	2,611

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	108	75
Overall Study	Lost to Follow-up	137	107
Overall Study	Withdrawal by Subject	86	107

Baseline characteristics

Characteristic	AC Then T	AC Then XT	Total
Age Continuous	51.2 years STANDARD_DEVIATION 8.81	50.6 years STANDARD_DEVIATION 9.19	50.9 years STANDARD_DEVIATION 9
Sex: Female, Male Female	1304 Participants	1307 Participants	2611 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	1,301 / 1,305	1,283 / 1,283
serious Total, serious adverse events	264 / 1,305	200 / 1,283

Outcome results

Primary

Disease Free Survival [Number of Events]

Number of patients with/without recurrence of breast cancer, or death due to any cause.

Time frame: Time from the date of randomization until the date of first event, or date last known to be event free if no event was reported. Patients were followed for an average of 5 years.