Phase 2
Completed N=19
Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer
Source: ClinicalTrials.gov NCT00429572 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcomePrimary: Number of Participants With Tumor Response — 5; 9; 1; 3 participants
Summary
Primary Objectives:
1. To assess the feasibility of mini-allogeneic Peripheral Blood Progenitor Cell (PBPC) transplantation in patients with recurrent or metastatic breast cancer.
2. To determine the success rate (complete remission without severe toxicity or death) at 100 days after the transplant and long-term progression free survival (PFS) rate.
3. To examine the graft vs. breast cancer effect of allogeneic PBPC transplantation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Tumor Response |
5; 9; 1; 3 | — |
| PRIMARY Overall Survival |
643 | — |
| PRIMARY Time to Progressive Disease |
202 | — |
| PRIMARY Grade II-IV Toxicity |
1; 3; 8; 0; 2; 2 | — |
| PRIMARY Number of Participants With Acute or Chronic GVHD And Response to Therapy |
9; 7; 14; 14 | — |
Eligibility Criteria
Inclusion Criteria
- Recurrent or residual metastatic breast carcinoma
- Zubrod performance status less than 2
- 18-60 years old
- Related donor human leukocyte antigen (HLA)-compatible for allogeneic transplantation or unrelated HLA-compatible donor.
- No major organ dysfunction or active infection
Exclusion Criteria: None
Data sourced from ClinicalTrials.gov (NCT00429572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.