Trial Outcomes & Findings for Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer (NCT NCT00304096)

NCT ID: NCT00304096

Last Updated: 2013-04-09

Results Overview

Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 days post administration of last vaccine
• Results posted on: 2013-04-09

Participant Flow

University of Virginia Dec 13, 2005 to May 6, 2008

12 participants were registered to the study and 11 received vaccines. One participant was not compliant and did not receive vaccine.

Participant milestones

Measure	Stratum 1: Received Hormonal Therapy Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy Participants had not received hormonal therapy
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

Baseline characteristics by cohort

Measure	Stratum 1: Received Hormonal Therapy n=6 Participants Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy n=5 Participants Participants had not received hormonal therapy	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age Continuous	56.7 years STANDARD_DEVIATION 5.75 • n=5 Participants	59.6 years STANDARD_DEVIATION 14.47 • n=7 Participants	58.0 years STANDARD_DEVIATION 10.13 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post administration of last vaccine

Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

Outcome measures

Measure	Stratum 1: Received Hormonal Therapy n=6 Participants Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy n=5 Participants Participants had not received hormonal therapy
The Number of Participants Who Experienced Dose-limiting Adverse Events	1 participants	0 participants

SECONDARY outcome

Timeframe: Days 1-78

Outcome measures

Measure	Stratum 1: Received Hormonal Therapy n=6 Participants Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy n=5 Participants Participants had not received hormonal therapy
The Number of Participants With T-cell Responses Against the Vaccine as Measured by Elispot Assay After 14 Day in Vitro Sensitization	5 participants	3 participants

Adverse Events

Stratum 1: Received Hormonal Therapy

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Stratum 2: Had Not Received Hormonal Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Stratum 1: Received Hormonal Therapy n=6 participants at risk Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy n=5 participants at risk Participants had not received hormonal therapy
General disorders Fever	16.7% 1/6 • Number of events 1 • 30 days post last vaccine	0.00% 0/5 • 30 days post last vaccine

Other adverse events

Measure	Stratum 1: Received Hormonal Therapy n=6 participants at risk Participants received hormonal therapy	Stratum 2: Had Not Received Hormonal Therapy n=5 participants at risk Participants had not received hormonal therapy
General disorders Fatigue	16.7% 1/6 • Number of events 1 • 30 days post last vaccine	0.00% 0/5 • 30 days post last vaccine
General disorders Pain, headache	0.00% 0/6 • 30 days post last vaccine	20.0% 1/5 • Number of events 1 • 30 days post last vaccine

Additional Information

Kimberly Bullock, PhD and David Brenin, MD

University of Virginia

Phone: 434-924-0180

Email: kb9d@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place