Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

NCT00796978 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CASE10107
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 11

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. PURPOSE: This phase II trial is studying the side effects of trastuzumab and to see how well it works in treating older women with early-stage breast cancer.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; HER2-positive breast cancer

Outcome Measures

Primary Outcomes (1)

• Percent of Participants Experiencing Cardiac Events at 1 Year

  Number of participants that experience cardiac events that include cardiac death due to congestive heart failure (CHF), Myocardial infarction (MI) or documented arrhythmia, death without definitive cause, or signs and symptoms of CHF as defined by New York Heart Association (NYHA) class III or IV symptoms.

  At 1 year

Secondary Outcomes (29)

• Percent of Participants Experiencing Cardiac Events at 3 Years

  At 3 years

• Percent of Participants Experiencing Cardiac Events at 5 Years

  At 5 years

• Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year

  At 1 year

• Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Three Years

  At 3 years

• Percent of Participants With Asymptomatic LV Cardiac Dysfunction at Five Years

  At 5 years

Study Arms (1)

trastuzumab

EXPERIMENTAL

Biological: trastuzumab; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: quality-of-life assessment

Interventions

trastuzumab BIOLOGICAL

Trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

Also known as: Herceptin

trastuzumab

laboratory biomarker analysis OTHER

Blood is collected every 6 weeks during treatment. Samples are assessed for plasma cardiac markers (N-terminal brain natriuretic protein and troponin-I) and pro-inflammatory cytokines (interleukin-6 and tumor necrosis factor-α).

trastuzumab

adjuvant therapy PROCEDURE

Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 52 weeks in the absence of disease progression or unacceptable toxicity.

trastuzumab

quality-of-life assessment PROCEDURE

Patients complete Quality of Life and Quality of Health and Comprehensive Geriatric assessments of functional, cognitive, and mental status changes at baseline, weeks 26, and 52.

trastuzumab

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed adenocarcinoma of the breast
• Immunohistochemical staining for Her2 protein of 3+ intensity or Her2 gene amplification of ≥ 2.0 by FISH testing.
• Life expectancy \> 6 months
• ECOG performance status ≤ 2
• Node positive disease irrespective of tumor size
• Node negative disease:
• TNM Stage (AJCC Cancer Staging Manual 6th edition) T1b-T4, N0-3, M0, irrespective of hormonal status
• Baseline LVEF ≥ lower limit of normal for a particular institution
• Complete surgical removal of invasive cancer by mastectomy or lumpectomy
• Complete staging work-up with CT of chest, abdomen, and pelvis plus bone scan or alternatively with PET scan for stage II and higher disease, or as determined by symptoms for all other stages. Additional staging work-up as per symptoms.
• Adequate bone marrow function as indicated by the following:
• ANC \>1000/µL
• Platelets ≥100,000/µL
• Hemoglobin \>10 g/dL
• Adequate liver function, as indicated by bilirubin ≤1.5 x upper limit of normal (ULN) Adequate renal function, as indicated by creatinine ≤1.5 x ULN

You may not qualify if:

• Enrollment after more than 120 days from the last day of mastectomy or lumpectomy
• Patients able to tolerate and willing to receive chemotherapy
• Prior chemotherapy for current malignancy
• Prior herceptin therapy
• Active cardiac disease
• Angina pectoris requiring anti-anginal treatment
• Documented congestive heart failure (CHF)
• Current use of any therapy specifically for CHF
• Cardiac arrhythmia requiring medication
• Current uncontrolled hypertension (diastolic \>100 mmHg or systolic \> 200 mmHg)
• Clinically significant valvular abnormality (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
• Clinically significant pericardial effusion (associated with New York Heart Association (NYHA) class II, III, or IV symptoms)
• Past cardiac disease
• Prior history of CHF
• History of cardiomyopathy

Sponsors & Collaborators

• Cynthia Owusu, MD: lead

Study Sites (11)

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Wake Forrest

Winston-Salem, North Carolina, 27157, United States

Location

Lake/University Seidman Cancer Center

Cleveland, Ohio, 44060, United States

Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

University Suburban Health Center

Cleveland, Ohio, 44121, United States

Location

UHHS Chagrin Highlands Medical Center

Cleveland, Ohio, 44122, United States

Location

Southwest General Health Center

Cleveland, Ohio, 44130, United States

Location

UHHS Westlake Medical Center

Cleveland, Ohio, 44145, United States

Location

UH-Monarch

Mayfield Heights, Ohio, 44124, United States

Location

Sharon Health Center

Wadsworth, Ohio, 44281, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Chemotherapy, Adjuvant

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; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: Dr. Cynthia Owusu
• Organization: Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

cynthia.owusu@uhhospitals.org

+1 216-844-7670

Study Officials

• Cynthia Owusu, MD, MSc

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: February 5, 2009
• Primary Completion: January 6, 2016
• Study Completion: February 26, 2020
• Last Updated: May 1, 2024
• Results First Posted: August 3, 2020

Record last verified: 2024-04

Locations

US (11)