Study Of Lapatinib In Combination With Paclitaxel In The Treatment Of Newly Diagnosed Inflammatory Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Daily-monotherapy \[1500 milligrams (mg)\] for 14 days, then daily combination therapy (with weekly paclitaxel) for 12 weeks
• Paclitaxel — DRUG
  Weekly (80mg/m\^2) combination therapy (with daily Lapatinib) for 12 weeks

Study Details

This Study was designed to determine how effective and safe a new investigational drug, lapatinib, is in combination with paclitaxel in treating patients with newly diagnosed inflammatory breast cancer. Tumor tissue collected pre-treatment, following 14 days of treatment and at the time of surgical resection will be examined for pathologic response and biologic activity by IHC (immunohistochemistry) within the tumor. Treatment will consist of 14 days of lapatinib monotherapy followed by 12 weeks of combination therapy with lapatinib and paclitaxel. Blood samples for hematology and chemistry panels, MUGA/ECHO exams and physical exams will be performed throughout the study to monitor safety.

Key Dates

Start date

Apr 11, 2005

Status verified

May 2017

Primary completion

Nov 1, 2006

Completion

Nov 1, 2006

Study Design

Enrollment

49 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Overall study
  A Single arm study with 2 cohorts of participants. Cohort A consists of participants with tumors overexpressing HER2 and/or EGFR. Cohort B consists of participants with tumors expressing EGFR without overexpressing HER2.

Primary Outcome Measure

Percentage of participants with pathologic complete response rate (pCR) [ Time Frame: Week 12 ]

Locations (4)

Find similar trials in Miami, FL