Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer

NCT00597597 | Terminated Phase 2 Results DMC

• 1 other identifier: OSI-TAR-721 | L06112402
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer. If erlotinib is shown to have activity, this could identify a form of targeted therapy for this specific subset of breast cancer patients. In addition, it may identify a subset of breast cancer patients with tumors that overexpress EGFR in whom other EGFR targeted therapies could warrant further testing.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer; ER and PR hormone receptor negative; HER2/neu negative; EGFR positive

Outcome Measures

Primary Outcomes (1)

• The Primary Objective of the Study is Progression Free Survival.

  From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death.

  From the Day of Initial Treatment (Day 0) Until Documented Disease Progression or Death, whichever came first, assessed up to 6 months.

Secondary Outcomes (5)

• Overall Response Rate, Consisting of Complete and Partial Responses According to RECIST Criteria

  every 8 weeks, up to 6 months

• Clinical Benefit, Consisting of Complete and Partial Responses, and Stable Disease for Six Months

  very 8 weeks, up to 6 months

• Duration of Objective Response

  every 8 weeks, up to 6 months

• Safety of Erlotinib

  2 years

• Number of Participants With Rash

  every 8 weeks, up to 6 months

Study Arms (1)

Open label Erlotinib

EXPERIMENTAL

Open label; In this open label study, all enrolled subjects receive active drug, Erlotinib

Drug: Erlotinib

Interventions

Erlotinib DRUG

During the treatment period, subjects will receive single agent erlotinib, 150mg/day.

Also known as: Tarceva

Open label Erlotinib

Eligibility Criteria

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

You may qualify if:

• Verbal and written informed consent to participate in the study.
• Women greater than or equal to 18 years of age.
• Histologically documented metastatic or locally advanced, incurable breast cancer with a tumor block available
• Less than or equal to 1 prior chemotherapy for metastatic or locally unresectable disease.
• Prior treatment with anthracycline and taxane chemotherapy, either in the adjuvant or metastatic setting
• Measurable disease on CT or PET scan or physical exam Disease at a previously irradiated site is considered measurable if there is clear evidence of disease progression following radiation therapy.
• ER-negative, PR-negative and HER2-neu-negative. Estrogen and progesterone status will be defined by immunohistochemistry. Her2/neu status will be considered negative if the ratio of the number of copies of the Her2/neu gene to the centromeric probe for chromosome 17 is approximately 1. This will be done by FISH (fluorescent in-situ hybridization) testing.
• EGFR-positive defined as strong membrane staining in greater than 10% of tumor cells by immuno-histochemistry (Dako).
• Pre- or post-menopausal.
• ECOG performance status of 0 - 2.
• Life expectancy of greater than or equal to 3 months.
• Use of barrier contraceptive methods in women of childbearing potential.
• Ability to comply with study and follow-up procedures.

You may not qualify if:

• Pleural effusions or blastic bone lesions as the only manifestations of the current metastatic breast cancer.
• Other primary malignancies within 5 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer.
• Symptomatic or untreated brain metastases. Subjects are eligible if they are neurologically stable after treatment for brain metastases and have been off steroids for greater than or equal to 4 weeks.
• Radiotherapy, immunotherapy, hormonal therapy or chemotherapy within 21 days prior to registration.
• Prior treatment with an agent that targets the EGFR or the EGFR-specific tyrosine kinase activity.
• Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 0, or serious cardiac arrhythmias requiring medication.
• Major surgery, biopsy of a parenchymal organ, or significant traumatic injury occurring within 21 days prior to Day 0.
• History of other diseases, metabolic dysfunction, physical examinations findings, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications.
• Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease.
• Pregnancy or lactation. A negative serum or urine pregnancy test is required for women of child-bearing potential during screening and within 7 - 10 days of Day 1 of Cycle 1 of erlotinib (Tarcevo®)administration. Men and premenopausal women of child bearing potential will follow an approved, medically accepted birth control regimen while taking erlotinib and for 30 days following the last dose of study drug.
• Active infection requiring parenteral antibiotics.
• Any of the following abnormal baseline hematologic values:
• Granulocyte count less than or equal to 1500/μL
• Platelet count less than or equal to 100,000/μL
• Hemoglobin less than or equal to 9g/dl (transfusion permitted)

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center Division of Hematology/Oncology

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• J Clin Oncol 29, 2011 (suppl 27; abstr 296)

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ruta Rao
• Organization: Rush University Medical Center

ruta_d_rao@rush.edu

312-942-3324

Study Officials

• Ruta D Rao, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 9, 2008
• First Posted: January 18, 2008
• Study Start: April 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 17, 2023
• Results First Posted: May 17, 2023

Record last verified: 2023-05

Locations

US (1)