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A Phase III Trial For Patients With Metastatic Breast Cancer

NCT ID: NCT00191152

Last Updated: 2009-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

475 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-02-28

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Breast Neoplasms Cancer of the Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemcitabine + Docetaxel

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression

docetaxel

Intervention Type DRUG

75 mg/m2, intravenous (IV), every 21 days until disease progression

Capecitabine + Docetaxel

Group Type ACTIVE_COMPARATOR

docetaxel

Intervention Type DRUG

75 mg/m2, intravenous (IV), every 21 days until disease progression

capecitabine

Intervention Type DRUG

1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

Interventions

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gemcitabine

1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression

Intervention Type DRUG

docetaxel

75 mg/m2, intravenous (IV), every 21 days until disease progression

Intervention Type DRUG

capecitabine

1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression

Intervention Type DRUG

Other Intervention Names

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LY188011 Gemzar

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Eli Lilly

Principal Investigators

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Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Glendale, Arizona, United States

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Fort Smith, Arkansas, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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Springdale, Arkansas, United States

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Berkeley, California, United States

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Fountain Valley, California, United States

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Highland, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Santa Rosa, California, United States

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Sylmar, California, United States

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Denver, Colorado, United States

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Torrington, Connecticut, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Orlando, Florida, United States

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Idaho Falls, Idaho, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Louisville, Kentucky, United States

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Metairie, Louisiana, United States

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Royal Oak, Michigan, United States

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Southfield, Michigan, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Fremont, Nebraska, United States

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Voorhees Township, New Jersey, United States

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New York, New York, United States

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Springfield, Ohio, United States

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Dunmore, Pennsylvania, United States

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Franklin, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Kittanning, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Knoxville, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Lubbock, Texas, United States

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San Antonio, Texas, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Capital Federal, , Argentina

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Mendoza, , Argentina

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Rosario, , Argentina

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Santa Fe, , Argentina

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Waratah, New South Wales, Australia

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Redcliffe, Queensland, Australia

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Ashford, South Australia, Australia

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Porto Alegre, , Brazil

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Acapulco, , Mexico

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Mexico City, , Mexico

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Michoacán, , Mexico

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Toluca, , Mexico

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San Juan, , Puerto Rico

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Seoul, , South Korea

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Countries

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United States Argentina Australia Brazil Mexico Puerto Rico South Korea Taiwan

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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B9E-US-S188

Identifier Type: -

Identifier Source: secondary_id

4703

Identifier Type: -

Identifier Source: org_study_id