Clinical trial · Interventional

Docetaxel, Vinorelbine and Trastuzumab in the Treatment of Patients With Metastatic Her-2 Positive Breast Cancer

Phase II Trial of Weekly Docetaxel, Vinorelbine, and Herceptin in the First-Line Treatment of Patients With Metastatic Breast Cancer and Overexpression of Her-2

NCT00193089CI-TRIAL-00020148completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

In this phase II trial we attempt to improve upon the efficacy of the trastuzumab/vinorelbine combination by adding weekly docetaxel. When administered on a weekly schedule, docetaxel is well tolerated with minimal myelosuppression, so that it is likely that fully efficacious doses of all three drugs can be administered

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Docetaxel	Drug	Docetaxel	ALIAS
Trastuzumab	Drug	Trastuzumab	ALIAS
Vinorelbine	Drug	Vinorelbine	ALIAS

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
feasibility and toxicity of the combination of weekly docetaxel, vinorelbine, and trastuzumab in patients with metastatic breast cancer who overexpress Her-2.
timeFrame
18 Months

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Overexpression of the Her-2 oncogene
* Age \> 18 years
* Measurable disease
* Able to perform activities of daily living with minimal assistance
* No previous chemotherapy for metastatic disease
* One or more previous hormonal therapies for metastatic disease.
* Adequate bone marrow, liver and kidney function
* Patients with \< grade 1 peripheral neuropathy are eligible.
* Must give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Abnormal heart function
* Previous treatment with trastuzumab
* Brain metastases untreated
* Pre-existing symptomatic peripheral neuropathy
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

References

Publications (1)

RESULTInfante JR, Yardley DA, Burris HA 3rd, Greco FA, Farley CP, Webb C, Spigel DR, Hainsworth JD. Phase II trial of weekly docetaxel, vinorelbine, and trastuzumab in the first-line treatment of patients with HER2-positive metastatic breast cancer. Clin Breast Cancer. 2009 Feb;9(1):23-8. doi: 10.3816/CBC.2009.n.004. PMID 19299236