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A Phase III Trial For Patients With Metastatic Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Phase III Trial For Patients With Metastatic Breast Cancer

Randomized Trial of Gemcitabine Plus Docetaxel vs. Docetaxel Plus Capecitabine in Metastatic Breast Cancer in 1st and 2nd

NCT00191152•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/ capecitabine doublets, with crossover to the alternate agent. The experimental arm will receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75 mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1 through 14 repeated every three weeks. Patients who progress on the experimental arm, will be treated with capecitabine as dosed on the comparator arm. Patients who progress on the comparator arm will be treated with gemcitabine as dosed on the experimental arm.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
•Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
•Patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
•Patients must have either measurable or non-measurable (evaluable) disease
•Prior radiation therapy allowed of less than 25% of the bone marrow

Exclusion Criteria

•Second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
•Parenchymal or leptomeningeal brain metastases
•Peripheral neuropathy greater than or equal to grade 2
•Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
•Active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
•Concomitant Herceptin is not allowed

Locations (65)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT-5 hours, EST), or speak with your personal physician.

Glendale, Arizona, United States

Fort Smith, Arkansas, United States

Hot Springs, Arkansas, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Little Rock, Arkansas, United States

Springdale, Arkansas, United States

Berkeley, California, United States

Fountain Valley, California, United States

Highland, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Key Dates

Start Date

February 1, 2002

Primary Completion Date

November 1, 2008

Completion Date

November 1, 2008

Last Updated

December 24, 2009

Enrollment

475

ACTUAL participants

Conditions

Breast CancerBreast NeoplasmsCancer of the Breast

Interventions

gemcitabine

DRUG

docetaxel

DRUG

capecitabine

DRUG

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

NCT05673200

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+2 more

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 24, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase III Trial For Patients With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer