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Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Phase I/II Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2/Neu Overexpression


OBJECTIVES:

- Determine the maximum tolerated dose and recommended phase II dose of erlotinib when
combined with trastuzumab (Herceptin) as first-line therapy in women with metastatic
breast cancer associated with HER2/neu overexpression. (Phase I closed to accrual as of
01/2004)

- Determine the safety profile of this regimen in these patients.

- Determine the rate and duration of objective response in patients treated with this
regimen.

- Determine the pharmacologic behavior of this regimen in these patients.

- Determine time to disease progression and duration of survival in patients treated with
this regimen.

- Correlate the antitumor activity of this regimen with epidermal growth factor receptor
expression in these patients.

OUTLINE: This is a dose-escalation study of erlotinib. (Phase I closed to accrual as of
01/2004).

Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab (Herceptin) IV
over 30-90 minutes (1-4 hours after erlotinib) once weekly beginning on day 1. Courses
repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional
patients are treated at the recommended phase II dose.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued for the phase I portion (closed
to accrual as of 01/2004) and 27-81 patients will be accrued for the phase II portion of
this study.


Inclusion Criteria:



- Women aged > 18 years

- Histologically documents metastatic breast cancer

- HER2 positive using FISH

- For phase I, patients who have previously received treatment for their metastatic
disease are allowed to participate.

- For the phase II portion of the study, patients must have measureable disease (> 2
cm; > 1 cm on spiral CT scan)

- ECOG performance status of 0 to 2

- A life expectancy of > 3 months

- Use of effective means of contraception

Exclusion Criteria:

- For Phase II, prior cytotoxic chemotherapy and/or prior Herceptin for their
metastatic disease. Prior treatment in the adjuvant setting is allowed.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The objective response rate as defined as the rate of complete and partial responses determined on two consecutive occasions greater than or equal to 4 weeks a part.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Carolyn Britten, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069295

NCT ID:

NCT00033514

Start Date:

August 2001

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781