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NCT Number: NCT00033514

Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. Combining trastuzumab with erlotinib may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2/neu overexpression.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged > 18 years
  • Histologically documents metastatic breast cancer
  • HER2 positive using Fluorescence In Situ Hybridization (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)
  • Eastern Cooperative Oncology Group (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.

Treatment and study plan

trastuzumab

Biological

Day 1 4mg/kg IV 2 mg/kg IV weekly.

Other names: Herceptin

Erlotinib Hydrochloride

Drug

100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol.

Other names: OSI-774

Primary outcomes

  1. The Objective Response Rate as Defined as Stable Disease or the Rate of Complete and Partial Responses Determined on Two Consecutive Occasions Greater Than or Equal to 4 Weeks Apart.

    Time frame: 5 years

    Complete Response:

    The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured. Also called complete remission.

    Partial Response:

    A decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment. Also called partial remission.

  2. Recommended Dose for Phase II

    Time frame: treatment period

Secondary outcomes

  1. Duration of Objective Response

    Time frame: 5 years

  2. Incidence of Adverse Events

    Time frame: 5 years

  3. Serum Concentration of Herceptin at Specified Time-points.

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Jonsson Comprehensive Cancer Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2011
Study completion
2011
First posted
Jan 27, 2003
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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