Phase 2 N=19 Treatment

Mini-Allogeneic Peripheral Blood Progenitor Cell Transplantation For Recurrent or Metastatic Breast Cancer

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00429572 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2011

Primary outcome: Primary: Number of Participants With Tumor Response — 5; 9; 1; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fludarabine (Drug); Melphalan (Drug); Stem Cell Infusion (Procedure)
Age: Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: May 2008

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	—

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.

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

View full record on ClinicalTrials.gov →

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.