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NCT00709761 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target
13
Study locations

NCT00709761: Completed Phase 2 study of Neoplasms, Breast, sponsored by Novartis Pharmaceuticals.

NCT00709761 is a Phase 2 study of Neoplasms, Breast that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 60 participants, below the 1,061-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (94% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00709761, a Phase 2 study of Neoplasms, Breast, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target
13
Study locations

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

Primary Outcome

OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR is defined as the disappearance of all lesions (target and/or non-target). PR is defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.

Conditions Studied

Neoplasms, Breast

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
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT00709761 record still lists

NCT00709761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,061-participant average among 9 other Neoplasms, Breast trials with a reported enrollment target (94% lower).

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.

NCT00709761 lists 13 locations in 8 states (California, New York, Ohio).

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.

What interventions are being tested in trial NCT00709761?

The interventions under investigation include: Lapatinib/nab-Paclitaxel (DRUG).

Who is sponsoring clinical trial NCT00709761?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Neoplasms, Breast

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00709761's enrollment target sits among peer trials

60 7th of 9 higher than 3 of 9 other Neoplasms, Breast trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Neoplasms, Breast trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00709761, the US trial registry maintained by the National Library of Medicine. NCT00709761 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.