Trial Outcomes & Findings for Herceptin and GM-CSF for Metastatic Breast Cancer (NCT NCT00429104)

Last Updated: 2012-12-06

Results Overview

Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

2 months

Results posted on

2012-12-06

Participant Flow

Recruitment Period of November 2002 to April 2007, all recruited at University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	HER2+ Metastatic Breast Cancer Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HER2+ Metastatic Breast Cancer Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Overall Study Protocol Violation	1

Baseline Characteristics

Herceptin and GM-CSF for Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HER2+ Metastatic Breast Cancer n=18 Participants Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Age Continuous	48 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.

Number of participants with response defined as stable disease or better using Response Evaluation Criteria In Solid Tumors (RECIST) at the month 2 evaluation.

Outcome measures

Outcome measures
Measure	HER2+ Metastatic Breast Cancer n=17 Participants Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Number of Participants With Tumor Response (Stable Disease)	5 participants

SECONDARY outcome

Timeframe: 6 Years

Population: Analysis was per protocol, and of 18 enrolled, one participant was inevaluable.

Stable disease is measured from the start of the treatment until the RECIST criteria for disease progression is met.

Outcome measures

Outcome measures
Measure	HER2+ Metastatic Breast Cancer n=17 Participants Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Duration of Stable Disease	15.8 weeks Interval 10.0 to 53.9

Adverse Events

HER2+ Metastatic Breast Cancer

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HER2+ Metastatic Breast Cancer n=17 participants at risk Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m\^2 subcutaneously
Gastrointestinal disorders Fever	17.6% 3/17 • 4 years and 6 months
Gastrointestinal disorders Nausea	11.8% 2/17 • 4 years and 6 months
Gastrointestinal disorders Vomitting	5.9% 1/17 • 4 years and 6 months
General disorders Sore Mouth	11.8% 2/17 • 4 years and 6 months
Gastrointestinal disorders Diarrhea	17.6% 3/17 • 4 years and 6 months
Gastrointestinal disorders Constipation	5.9% 1/17 • 4 years and 6 months
General disorders Fatigue	29.4% 5/17 • 4 years and 6 months
Musculoskeletal and connective tissue disorders Muscle Pain	23.5% 4/17 • 4 years and 6 months
Nervous system disorders Numbness	5.9% 1/17 • 4 years and 6 months
Nervous system disorders Sore finger/toes	5.9% 1/17 • 4 years and 6 months
Eye disorders Red eye	5.9% 1/17 • 4 years and 6 months
Skin and subcutaneous tissue disorders Rash at injection site	41.2% 7/17 • 4 years and 6 months
Skin and subcutaneous tissue disorders Skin Rash	35.3% 6/17 • 4 years and 6 months
General disorders Itchy hands/feet	5.9% 1/17 • 4 years and 6 months
General disorders Headache	11.8% 2/17 • 4 years and 6 months

Additional Information

Naoto Ueno, MD.PhD./Professor

University of Texas MD Anderson Cancer Center

Phone: 713-792-8754

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place