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COMPLETED Phase 2

Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC

NCT00709761 · View on ClinicalTrials.gov ↗

Study Summary

This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receive nab-paclitaxel (100 mg/m2 intravenously once weekly for 3 weeks, followed by a rest week in a 4-week cycle) plus lapatinib (1000 mg once daily). Subjects were to receive treatment until disease progression or withdrawal from the study. The primary objective of this study was to evaluate overall tumor response rate of lapatinib in combination with nab-paclitaxel administered in women with ErbB2 overexpressing MBC who received no chemotherapeutic regimen in the metastatic setting. Secondary objectives included progression-free survival, overall survival, duration of response, time to response and time to progression and safety. Safety and efficacy assessments were to be performed at 8 and 12 week intervals, and at the end of treatment. Subject: Metastatic Breast Cancer, ErbB2, First-line therapy, Lapatinib, Nab-paclitaxel

Conditions Studied

Interventions

  • DRUG Lapatinib/nab-Paclitaxel

Study Locations (13)

California

  • Novartis Investigative Site — La Verne
  • Novartis Investigative Site — Long Beach

New York

  • Novartis Investigative Site — New York
  • Novartis Investigative Site — Rochester

Ohio

  • Novartis Investigative Site — Cincinnati
  • Novartis Investigative Site — Cleveland

Virginia

  • Novartis Investigative Site — Richmond
  • Novartis Investigative Site — Salem

Washington

  • Novartis Investigative Site — Everett
  • Novartis Investigative Site — Tacoma

Florida

  • Novartis Investigative Site — Fort Myers

Georgia

  • Novartis Investigative Site — Atlanta

Tennessee

  • Novartis Investigative Site — Nashville

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2008-07-02
Est. Completion 2018-01-03
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00709761

The ClinicalTrials.gov registry entry for NCT00709761 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Neoplasms, Breast appearing as the primary indexed condition, and to 1 intervention — of which Lapatinib/nab-Paclitaxel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00709761 reports 13 study locations spanning 8 distinct geographic areas — top geographies include California, New York, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00709761 about?

NCT00709761 is a clinical study titled "Phase II Lapatinib Plus Nab-Paclitaxel As First And Second Line Therapy In her2+ MBC". This was an open-label, single-arm, multi-center, Phase II study to determine the activity of nab-paclitaxel plus lapatinib in the first and second-line setting in women with ErbB2 overexpressing metastatic breast cancer (MBC). Sixty subjects were to be enrolled in the study. Subjects were to receiv...

What is the current status of trial NCT00709761?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-07-02. Estimated completion is 2018-01-03.

What conditions does trial NCT00709761 study?

This clinical trial studies the following conditions: Neoplasms, Breast. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00709761?

The interventions under investigation include: Lapatinib/nab-Paclitaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00709761?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00709761 being conducted?

This trial has 13 study locations across California, Florida, Georgia, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial