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

NCT00033514 | Completed Phase 1 Results DMC

• 4 other identifiers: 01-06-020CDR0000069295GENENTECH-OSI2365sNCI-G02-2057
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  5 years

• Recommended Dose for Phase II

  treatment period

Secondary Outcomes (3)

• Duration of Objective Response

  5 years

• Incidence of Adverse Events

  5 years

• Serum Concentration of Herceptin at Specified Time-points.

  4 months

Study Arms (1)

treatment

EXPERIMENTAL

please see intervention description

Biological: trastuzumab; Drug: erlotinib hydrochloride

Interventions

trastuzumab BIOLOGICAL

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

Also known as: Herceptin

treatment

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.

Also known as: OSI-774

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Related Publications (1)

• Britten CD, Finn RS, Bosserman LD, Wong SG, Press MF, Malik M, Lum BL, Slamon DJ. A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach. Clin Breast Cancer. 2009 Feb;9(1):16-22. doi: 10.3816/CBC.2009.n.003.

  PMID: 19299235 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Carolyn Britten
• Organization: Medical University of South Carolina

britten@musc.edu

843-792-4271

Study Officials

• Carolyn Britten, MD

  Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 8, 2020
• Results First Posted: April 11, 2016

Record last verified: 2016-02

Locations

US (1)