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

NCT ID: NCT00089479

Last Updated: 2012-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

capecitabine [Xeloda]

Intervention Type DRUG

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

Taxotere

Intervention Type DRUG

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

2

Group Type ACTIVE_COMPARATOR

Taxotere

Intervention Type DRUG

100mg/m2 iv on day 1 of each 3 week cycle

Interventions

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capecitabine [Xeloda]

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

Intervention Type DRUG

Taxotere

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

Intervention Type DRUG

Taxotere

100mg/m2 iv on day 1 of each 3 week cycle

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Houston, Texas, United States

Site Status

Countries

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United States

References

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Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

Reference Type DERIVED
PMID: 34037241 (View on PubMed)

Other Identifiers

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NO17629

Identifier Type: -

Identifier Source: org_study_id