Docetaxel in Treating Patients With Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Study Completion Date

2007-01-31

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

Detailed Description

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OBJECTIVES:

* Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks.
* Compare the safety and toxicity of these regimens in these patients.
* Evaluate the maintenance of relative dose intensity with each regimen in these patients.
* Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.
* Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Treatment continues in both arms in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Conditions

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Breast Cancer

Keywords

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stage IV breast cancer recurrent breast cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Docetaxel Weekly

Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.

Docetaxel Every 3 Weeks

Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days.

Group Type EXPERIMENTAL

Docetaxel

Intervention Type DRUG

Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.

Interventions

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Docetaxel

Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.

Intervention Type DRUG

Docetaxel

35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.

Intervention Type DRUG

Other Intervention Names

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Taxotere Taxotere

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed metastatic breast cancer
* Bidimensionally measurable disease
* No uncontrolled brain metastases or leptomeningeal disease
* Hormone receptor status:

* Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Not specified

Performance status:

* Zubrod 0-2

Life expectancy:

* At least 3 months

Hematopoietic:

* Platelet count at least 100,000/mm\^3
* Neutrophil count at least 1,000/mm\^3
* Hemoglobin at least 8 g/dL

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN)
* Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN)

Renal:

* Creatinine no greater than 2.0 mg/dL

Neurologic:

* No peripheral neuropathy grade 2 or greater
* Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis
* No psychiatric disorders

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy
* No other serious condition or illness, including active infection
* No history of hypersensitivity to polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Recovered from prior chemotherapy
* No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease)
* No prior paclitaxel or docetaxel (except in the adjuvant setting)
* At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel)
* Prior anthracycline-based therapy allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* At least 2 weeks since prior radiotherapy and recovered

Surgery:

* At least 2 weeks since prior surgery and recovered

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edgardo Rivera, MD

Role: STUDY_CHAIR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center at University of Texas

Houston, Texas, United States

Site Status

University of Texas M.D. Anderson CCOP Research Base

Houston, Texas, United States

Site Status

Countries

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United States

References

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Rivera E, Mejia JA, Arun BK, Adinin RB, Walters RS, Brewster A, Broglio KR, Yin G, Esmaeli B, Hortobagyi GN, Valero V. Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer. Cancer. 2008 Apr 1;112(7):1455-61. doi: 10.1002/cncr.23321.

Reference Type RESULT

PMID: 18300256 (View on PubMed)