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

NCT00089479 | Completed Phase 3 Results

• 1 other identifier: NO17629
• Study Type: interventional
• Target: 2,611
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Disease Free Survival [Number of Events]

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

  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 [Time to Event]

  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.

  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.

Secondary Outcomes (8)

• 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.

• 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.

• 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 .

• 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.

• 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.

Study Arms (2)

1

EXPERIMENTAL

Drug: capecitabine [Xeloda]; Drug: Taxotere

2

ACTIVE COMPARATOR

Drug: Taxotere

Interventions

capecitabine [Xeloda] DRUG

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

1

Taxotere DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Houston, Texas, 77060, United States

Location

Related Publications (1)

• 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.

  PMID: 34037241 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2004
• First Posted: August 6, 2004
• Study Start: August 1, 2002
• Primary Completion: June 1, 2010
• Study Completion: May 1, 2012
• Last Updated: December 21, 2012
• Results First Posted: June 23, 2011

Record last verified: 2012-12

Locations

US (1)