Trial Outcomes & Findings for Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women) (NCT NCT00499083)
NCT ID: NCT00499083
Last Updated: 2023-09-29
Results Overview
Assessed by the institutional pathologist. * Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs * Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs * Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis * Grade 4: no or few modifications of the tumor appearance
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
At definitive surgery.
Results posted on
2023-09-29
Participant Flow
Participant milestones
| Measure |
Vaccine
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Overall Study
STARTED
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17
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Overall Study
Participants at UNMC
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3
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Overall Study
Participants at Moffitt Cancer Center
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14
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Overall Study
COMPLETED
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14
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Overall Study
NOT COMPLETED
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3
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Reasons for withdrawal
| Measure |
Vaccine
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Overall Study
Not evaluable
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3
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Baseline Characteristics
Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)
Baseline characteristics by cohort
| Measure |
Vaccine
n=14 Participants
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Age, Continuous
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51.5 years
n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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14 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At definitive surgery.Assessed by the institutional pathologist. * Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs * Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs * Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis * Grade 4: no or few modifications of the tumor appearance
Outcome measures
| Measure |
Vaccine
n=14 Participants
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Number of Patients With Pathological Complete Response
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2 participants
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SECONDARY outcome
Timeframe: Post-vaccination peripheral blood (PB) after the last chemotherapy.Population: Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.
T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-vaccination peripheral blood (PB) after the last chemotherapy.Population: Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.
T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Post-vaccination peripheral blood (PB) after the last chemotherapy.Population: Evaluation of this data is unknown as was not provided by collaborating center performing the analysis.
T cell response to tumor-specific Ag, will be measured by ELISPOT assay with a biologic response defined as double the average ELISPOT reactivity in post-vaccination peripheral blood (PB) compared to pre-vaccination PB.
Outcome measures
Outcome data not reported
Adverse Events
Vaccine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vaccine
n=3 participants at risk
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Blood and lymphatic system disorders
Febrile neutropenia
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Other adverse events
| Measure |
Vaccine
n=3 participants at risk
Patients with HER-2/neu negative tumors received therapeutic autologous dendritic cells: injected into the primary breast mass or palpable axillary node, one week after the first, second and third T treatments.
Adjuvant hormone therapy for patients having tumors with estrogen and/or progesterone receptors. Premenopausal patients will be treated with tamoxifen. Post or perimenopausal women may receive tamoxifen or an aromatase inhibitor.
Patients received 4 cycles of paclitaxel: 175 mg/m2 (IV), followed by 4 cycles of cyclophosphamide: 600 mg/m2 IV and doxorubicin hydrochloride: 60 mg/m2 IV in a bi-weekly dose dense fashion
All patients had pre-treatment biopsy and second tumor biopsy after 4 cycles of paclitaxel to evaluate responses to the dendritic cell injections.
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|---|---|
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Vascular disorders
Thromboembolic event
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Metabolism and nutrition disorders
hypokalemia
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Gastrointestinal disorders
mucositis oral
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Skin and subcutaneous tissue disorders
palmar-plantar erythrodysesthesia
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Musculoskeletal and connective tissue disorders
bone pain
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Investigations
white blood cell decreased
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Investigations
neutrophil count decreased
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33.3%
1/3 • Number of events 1 • Adverse events were collected from the time of when patients consented to the study until 30 day after completion of the study treatment, up to 6 months.
Grade 3/4 toxicities were collected for this study. Complete evaluation of this data is unknown. We only have adverse event data from UNMC.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place