Trial Outcomes & Findings for Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer (NCT NCT00847171)
NCT ID: NCT00847171
Last Updated: 2018-09-26
Results Overview
Safety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
4 years
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
n=20 Participants
Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
|
|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsSafety as assessed by number of participants who experienced drug-related local and systemic toxicity, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0) in response to CY-modulated immunization with a novel breast cancer vaccine in the setting of weekly Trastuzumab therapy.
Outcome measures
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
n=20 Participants
All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
|
|---|---|
|
Safety as Assessed by Number of Participants Experiencing Toxicity
Patients with drug-related toxicity
|
20 Participants
|
|
Safety as Assessed by Number of Participants Experiencing Toxicity
Patients with grade 3+ drug-related toxicity
|
0 Participants
|
|
Safety as Assessed by Number of Participants Experiencing Toxicity
Patients with serious drug-related toxicity
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 yearsOutcome measures
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
n=20 Participants
All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
|
|---|---|
|
Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
DTH-positive at baseline
|
12 Participants
|
|
Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
Increased DTH from baseline
|
11 Participants
|
|
Number of Participants With Immunologic Response as Determined by Delayed-type Hypersensitivity (DTH) Response to HER2/Neu-derived Peptides
Converted from DTH-negative to DTH-positive
|
5 Participants
|
SECONDARY outcome
Timeframe: 4 yearsPopulation: Only 13/20 participants had early stage disease, and 7/20 participants had a history of metastatic disease at the start of the study. All participants were assigned to the same treatment group.
Number of participants without evidence of disease progression.
Outcome measures
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
n=20 Participants
All patients receive weekly Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
|
|---|---|
|
Clinical Benefit as Assessed by Number of Participants With Progression-free Survival
Patients with early stage disease
|
12 Participants
|
|
Clinical Benefit as Assessed by Number of Participants With Progression-free Survival
Patients with metastatic disease
|
6 Participants
|
Adverse Events
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Trastuzumab, Cyclophosphamide, and a Breast Tumor Vaccine
n=20 participants at risk
Patients receive Trastuzumab (T), Cyclophosphamide (CY), and an allogeneic GM-CSF-secreting whole cell breast cancer vaccine
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema/swelling of vaccine sites
|
100.0%
20/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Pain/soreness/tenderness of vaccine sites
|
100.0%
20/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Pruritus of vaccine sites
|
100.0%
20/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Blister at vaccine site
|
80.0%
16/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Dry skin at vaccine site
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis at vaccine site
|
30.0%
6/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Eczema at vaccine site
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Edema at vaccine site
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Hives at vaccine site
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation at vaccine site
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash at vaccine site
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Warmth at vaccine site
|
70.0%
14/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Gastrointestinal disorders
Anorexia
|
25.0%
5/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Arthralgia
|
45.0%
9/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Blisters
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Chills
|
50.0%
10/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Gastrointestinal disorders
Cramps
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Nervous system disorders
Dizziness
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
15.0%
3/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Fatigue
|
50.0%
10/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Fever
|
35.0%
7/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Flu-like symptoms
|
15.0%
3/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Nervous system disorders
Headache
|
40.0%
8/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Psychiatric disorders
Insomnia
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
20.0%
4/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Malaise
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
8/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
4/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain, bone
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
General disorders
Sweats
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
2/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
1/20 • Adverse events were collected at weekly time points after each vaccine administration for the duration of the study, an average of 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place