Recruitment

Recruitment Status
Active, not recruiting

Inclusion Criteria

Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
Willing to use birth control if necessary.
Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
...
Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
Willing to use birth control if necessary.
Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
Women of childbearing age with a negative pregnancy test documented prior to enrollment.
Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Women over Age 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

Exclusion Criteria

Pregnant or lactating.
Positive for positive HIV or hepatitis C at baseline.
Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
...
Pregnant or lactating.
Positive for positive HIV or hepatitis C at baseline.
Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
Major cardiac illness MUGA less than 50% EF.

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Prevention

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only females

Description

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prev...

Dendritic cell cancer vaccines combined with chemotherapy may increase complete responses giving breast cancer specific immune cells greater opportunity to function while the immune repertoire is being shifted by chemotherapy to anti-breast cancer response and offer the chance to test secondary prevention of breast cancer in high risk settings. Participants with HER-2 driven IBC at least Stage IIIA with N2 (4 positive nodes) following chemotherapy with or without trastuzumab or those with recurrence exclusive of new primary tumor but rendered NED will be undergo mammograms, laboratory studies, and leukapheresis. Vaccines will be manufactured using participants' leukapheresis product, which will be administered in the Clinical Research Center 1 Dulles Building weekly for 6 weeks. Three booster vaccines will be administered at 3 month intervals following the initial induction vaccines. Immune analysis will be done after participant receives all induction vaccines and again after they receive all booster vaccines. This study began at the Abramson Cancer Center of the University of Pennsylvania and will be continued at H. Lee Moffitt Cancer Center and Research Institute.

Inclusion Criteria

Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
Willing to use birth control if necessary.
Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
...
Deemed to require anti-estrogen therapy for treatment of their breast cancer can continue anti-estrogen therapy during vaccinations.
Willing to use birth control if necessary.
Potential participants with Invasive Breast Cancer at least Stage IIIA, greater than or equal to N2 (>4 positive nodes) or have recurrent metastatic breast cancer rendered NED by any means that are classic HER-2 3+ 30%, 2+ IHC and FISH positive or HER-2 2+ FISH negative, that have completed chemotherapy and/or trastuzumab and are within 1 year from their last treatment and have no evidence of disease.
Women of childbearing age with a negative pregnancy test documented prior to enrollment.
Have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Women over Age 18 years.
Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0 or 1.

Exclusion Criteria

Pregnant or lactating.
Positive for positive HIV or hepatitis C at baseline.
Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
...
Pregnant or lactating.
Positive for positive HIV or hepatitis C at baseline.
Pre-existing medical illnesses or medications which might interfere with the study as determined by Principal Investigator (PI).
Patients with coagulopathies, including thrombocytopenia with platelet count less than 75,000, INR greater than 1.5 and partial thromboplastin time greater than 50 sec.
Major cardiac illness MUGA less than 50% EF.

Tracking Information

NCT #
NCT02063724
Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
  • Principal Investigator: Brian Czerniecki, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute
  • Brian Czerniecki, M.D., Ph.D. H. Lee Moffitt Cancer Center and Research Institute