Trial Outcomes & Findings for Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer (NCT NCT02018458)
NCT ID: NCT02018458
Last Updated: 2021-10-11
Results Overview
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
4 years
Results posted on
2021-10-11
Participant Flow
Arm "ER+/HER2- BC: DC vaccine + preop chemo" is not included in these results, as no participants were enrolled in this arm with these hormone receptor criteria.
Participant milestones
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
|
|---|---|
|
Overall Study
Death
|
4
|
Baseline Characteristics
Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer
Baseline characteristics by cohort
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 Participants
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
10 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 yearsPopulation: Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria.
Toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 . This will include all patients (eligible and ineligible) who receive at least 1 inoculation of DC vaccine therapy. This safety population will also be used for the summaries and analysis of all safety parameters (drug exposure, tables of adverse events information, including serious adverse events, etc.).
Outcome measures
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 Participants
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
|
|---|---|
|
Safety of DC Vaccine Combined With Chemotherapy
|
10 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All eligible patients who have received at least 1 inoculation of DC vaccine therapy will be assessed for pathologic complete response.
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2 did not enroll any patients. The pathologic specimen will be graded per the tumor regression grading schema provided by the University of Texas MD Anderson Cancer Center "Residual Cancer Burden Calculator" at http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3. The following parameters are required from pathologic examination in order to calculate RCB: largest 2 dimensions of residual tumor bed in the breast; entire largest cross-sectional area of residual tumor bed; percentage of the tumor bed area that contains carcinoma; percentage of carcinoma in tumor bed that is in situ; number of positive (metastatic) lymph nodes; largest diameter of largest nodal metastasis. A pathologic complete response is defined as NO pathologic evidence of invasive disease in the breast or axillary lymph nodes. RCB-I (minimal cancer burden); RCB-II (moderate burden); and RCB-III (extensive burden).
Outcome measures
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 Participants
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
|
|---|---|
|
Pathologic Complete Response Rate
pathologic complete response (pCR)
|
4 Participants
|
|
Pathologic Complete Response Rate
Residual Cancer Burden 1 (RCB1)
|
3 Participants
|
|
Pathologic Complete Response Rate
Residual Disease (RD)
|
3 Participants
|
SECONDARY outcome
Timeframe: 36 monthsPopulation: All eligible patients who have received at least 1 inoculation of DC vaccine therapy.
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. Analysis of disease-free survival ("DFS", reported in months) was calculated from the first day of treatment up to 36 months.
Outcome measures
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 Participants
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy
|
|---|---|
|
Disease-free Survival
|
15.6 months
Interval 6.5 to 26.32
|
Adverse Events
LA TNBC: DC Vaccine+Preop Chemo
Serious events: 3 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 participants at risk
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Cardiac disorders
Right atrial thrombosis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
cellulitis of right breast
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
Other adverse events
| Measure |
LA TNBC: DC Vaccine+Preop Chemo
n=10 participants at risk
LA TNBC patients will be enrolled to receive DC vaccinations during the 24 weeks of standard preoperative dose-dense doxorubicin/cyclophosphamide (AC) followed by paclitaxel and carboplatin (TCb) chemotherapy.
|
|---|---|
|
Gastrointestinal disorders
Gastroesophageal Reflux
|
40.0%
4/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Hot Flashes
|
50.0%
5/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
10/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
30.0%
3/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Nodule Left Arm
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Tingling
|
50.0%
5/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
5/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Fever
|
40.0%
4/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Headache
|
100.0%
10/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Chills
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Mucositis
|
50.0%
5/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Infections and infestations
Oral Candidiasis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
10/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Fatigue
|
80.0%
8/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Gastroenteritis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Parageusia
|
60.0%
6/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Pruritus
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Venous Access Failure
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Right Axilla Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Right breast cellulitis post reconstruction/expanders surgery
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Weight loss
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Infections and infestations
Sore Throat
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Lower Back Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Vascular disorders
Epistaxis
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Sleep Disturbance
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Peripheral Neuropathy hands and feet
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
4/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Seroma Left Axilla
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Upper Abdomen Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Blurred Vision
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Tingling of the Tongue
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Peripheral Neuropathy arms and hands
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Peripheral Neuropathy bilateral feet
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Cardiac disorders
flutter in chest
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Psychiatric disorders
Depression
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Renal and urinary disorders
UTI
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
30.0%
3/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Constipation
|
30.0%
3/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Vascular disorders
DVT LLE
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Intermittent Neuropathy in Toes
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Right breast focal fibrosis with fat necrosis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Numbness of feet
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Infections and infestations
Fungal infection left great toe
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Seroma bilateral breast
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Redness Right Breast
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Left big toe brittle nail
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Vascular disorders
Right upper extremity lymphedema
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Cardiac disorders
Chest Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Dehydration
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Dizziness
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Intermittent Neuropathy
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Infections and infestations
Herpes Genitalis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Pain Right Shoulder
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Investigations
Vibrating Apheresis
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Cardiac disorders
Tachycardia
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Gastrointestinal disorders
Mouth Sores
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Insect Bite
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Mastalgia right breast
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Neuropathy
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Endocrine disorders
Hyperglycemia
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgias
|
20.0%
2/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
General disorders
Hypovitaminosis
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Skin and subcutaneous tissue disorders
Chemo induced nails bruised
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Neuropathy bilateral lower extremity
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tenderness of lymph nodes in right armpit
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Cardiac disorders
Hypertension
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint popping in hands
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
|
Nervous system disorders
Neuropathy in hands and feet
|
10.0%
1/10 • Up to 4 years
Results are only reported for Arm 1, "LA TNBC: DC vaccine+preop chemo patients". Arm 2, "ER+/HER2- BC: DC vaccine+preop chemo patients" did not enroll any patients with these hormone receptor criteria. All Grade 2, 3 and 4 adverse events (AEs), Grades 1 and 2 alopecia, and all grades of neutropenia will be recorded in the CRF throughout the trial. All AEs will be recorded for up to 30 days following the last study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place