NCT00796978

Trastuzumab in Treating Older Women With Early-Stage Breast Cancer

Completed Phase 2 Results posted Last updated 1 May 2024

What this trial tests

Phase 2 trial testing trastuzumab in Breast Cancer in 56 participants. Completed in 26 February 2020.

Timeline

5 February 2009

Primary endpoint
6 January 2016

26 February 2020

Quick facts

Lead sponsor	Cynthia Owusu, MD
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	5 February 2009
Primary completion	6 January 2016
Estimated completion	26 February 2020
Sites	11 locations across United States

Drugs / interventions tested

• trastuzumab (trastuzumab) — full drug profile →
• laboratory biomarker analysis — full drug profile →
• adjuvant therapy — full drug profile →
• quality-of-life assessment

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Cynthia Owusu, MD

Who can join

60 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent of Participants Experiencing Cardiac Events at 1 Year Primary · 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.

Group	Value	95% CI
Trastuzumab	3.6	0.09 – 13.8

Percent of Participants of Asymptomatic Left Ventricular (LV) Cardiac Dysfunction at 1 Year Secondary · At 1 year

One-year cumulative incidence of LV cardiac dysfunction as measured by percent of participants that had asymptomatic LV cardiac dysfunction with/without permanent discontinuation

Group	Value	95% CI
Trastuzumab	9.1	3.9 – 20.1

Percent of Participants With Disease-free Survival (DFS) Secondary · At 1 year

Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.

Group	Value	95% CI
Trastuzumab	96.36	86.23 – 99.08

Percent of Participants With DFS Secondary · At 2 years

Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.

Group	Value	95% CI
Trastuzumab	94.47	83.83 – 98.18

Percent of Participants With Disease-free Survival (DFS) Secondary · At 3 years

Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.

Group	Value	95% CI
Trastuzumab	92.46	81.13 – 97.11

Percent of Participants With Disease-free Survival (DFS) Secondary · At 5 years

Percent of participants with DFS measured between the time from initiation of treatment to the date of first loco-regional or distant treatment failure, ignoring any intervening contralateral breast cancers or other second primary cancers. Deaths without evidence of recurrence will be treated censoring events.

Group	Value	95% CI
Trastuzumab	86.4	73.59 – 93.30

Overall Survival (OS) as Measured by Percent of Participants Alive at 1 Year Secondary · Up to 1 years

OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.

Group	Value	95% CI
Trastuzumab	100.0	100.0 – 100.0

Overall Survival (OS) as Measured by Percent of Participants Alive at 2 Years Secondary · Up to 2 years

OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.

Group	Value	95% CI
Trastuzumab	100.0	100.0 – 100.0

Overall Survival (OS) as Measured by Percent of Participants Alive at 3 Years Secondary · Up to 3 years

OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.

Group	Value	95% CI
Trastuzumab	94.23	83.17 – 98.10

Overall Survival (OS) as Measured by Percent of Participants Alive at 5 Years Secondary · Up to 5 years

OS defined as percent of participants alive between time from initiation of treatment to the date of protocol-defined outcome from any cause and censored to the date of last follow-up for survivors.

Group	Value	95% CI
Trastuzumab	90.2	79.91 – 97.70

Mean Change in Quality of Life From Baseline to Mid-treatment Secondary · From Baseline to mid-treatment (week 26)

Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL.

Group	Value	95% CI
Trastuzumab	-2.8	± 17.9

Mean Change in Quality of Life From Baseline to End of Treatment Secondary · From baseline to end-of-treatment (52 weeks)

Quality of life was assessed by using the mean change in Functional Assessment of Cancer Therapy-Breast (FACTB) scoring instrument. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 37-item instrument designed to measure five domains of HRQOL in breast cancer patients: Physical, social, emotional, and functional well-being, as well as a breast-cancer subscale (BCS). Each question response is based on a 5-point Likert-type scale. Scores range from 0-148. High scores indicate better QOL.

Group	Value	95% CI
Trastuzumab	-9.2	± 24.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Event Data was collected up to 5 years of study participation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Trastuzumab

Serious: 8/56 (14%)

Deaths: 5/56

Serious adverse events (12 terms)

Reaction	System	Trastuzumab
Fracture	Musculoskeletal and connective tissue disorders	—
Heart failure	Cardiac disorders	—
Dehydration	Gastrointestinal disorders	—
Diarrhea	Gastrointestinal disorders	—
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary)	Infections and infestations	—
Sodium, serum-low (hyponatremia)	Metabolism and nutrition disorders	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—
Pulmonary/Upper Respiratory - Other (Specify, _Flu_)	Respiratory, thoracic and mediastinal disorders	—
Thrombosis/thrombus/embolism	Vascular disorders	—
Platelets	Blood and lymphatic system disorders	—
Left ventricular systolic dysfunction	Cardiac disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Trastuzumab
Hypertension	Cardiac disorders	—
Left ventricular systolic dysfunction	Cardiac disorders	—
Lymphopenia	Blood and lymphatic system disorders	—
Diarrhea	Gastrointestinal disorders	—
Infection with unknown ANC - Urinary tract NOS	Infections and infestations	—
Glomerular filtration rate	Metabolism and nutrition disorders	—
Glucose, serum-low (hypoglycemia)	Metabolism and nutrition disorders	—
Sodium, serum-low (hyponatremia)	Metabolism and nutrition disorders	—
Left ankle sprain	Musculoskeletal and connective tissue disorders	—
Pain- Buttock	Musculoskeletal and connective tissue disorders	—
CNS cerebrovascular ischemia	Nervous system disorders	—
Confusion	Nervous system disorders	—
Pain-Kidney	General disorders	—
Dyspnea (shortness of breath)	Respiratory, thoracic and mediastinal disorders	—
Hypoxia	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Fracture, Heart failure, Dehydration, Diarrhea, Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary), Sodium, serum-low (hyponatremia), Dyspnea (shortness of breath), Hypoxia.

Data from ClinicalTrials.gov NCT00796978 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardiotoxicity of breast cancer drug treatments.
   Haque M, Atallah N, Patke R, Harris AE, et al · · 2025 · cited 2× · PMID 40090070 · DOI 10.1016/j.tranon.2025.102352