Trial Outcomes & Findings for Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer (NCT NCT00429182)

NCT ID: NCT00429182

Last Updated: 2013-04-10

Results Overview

Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 32 participants
• Primary outcome timeframe: Baseline to 1 month post AHST
• Results posted on: 2013-04-10

Participant Flow

Recruitment Period: February 27, 2007 to July 25, 2011. All Recruitment done at The University of Texas (UT) MD Anderson Cancer Center.

Participant milestones

Measure	High-dose Chemotherapy Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Overall Study STARTED	32
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	High-dose Chemotherapy Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Overall Study Not evaluable, Disease Progression	2
Overall Study Not eligible	5

Baseline Characteristics

Purged Circulating Tumor Cells (CTCs) From Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	High-dose Chemotherapy n=32 Participants Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Age Continuous	44 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 1 month post AHST

Population: Twenty-one participants provided blood samples for the enumeration of CTCs, before apheresis (baseline) and at one month after AHST.

Number of circulating tumor cells (CTCs) measured at one month post autologous hematopoietic stem cell transplantation (AHST), considered both as longitudinal values and compared to the baseline number of CTCs.

Outcome measures

Measure

High-dose Chemotherapy n=21 Participants Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.

Number of Participants With Reduction in CTCs Following High-dose Chemotherapy With Purged Autologous Stem Cell Products

9 participants

SECONDARY outcome

Timeframe: Overall study (baseline to disease progression)

Population: Six participants were not evaluable for outcome assessment.

Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. PFS time measured in months.

Outcome measures

Measure

High-dose Chemotherapy n=26 Participants Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.

Median Progression Free Survival (PFS)

10.6 months Interval 1.0 to 16.4

Adverse Events

High-dose Chemotherapy

Serious events: 2 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	High-dose Chemotherapy n=32 participants at risk Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Blood and lymphatic system disorders Thrombocytopenia	3.1% 1/32 • 4 years and 5 months
General disorders Death	3.1% 1/32 • 4 years and 5 months

Other adverse events

Measure	High-dose Chemotherapy n=32 participants at risk Carboplatin + Cyclophosphamide + Thiotepa Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion. Thiotepa : 120 mg/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion. Stem Cell Transplant : Stem Cell Transplant on Day 0. Cyclophosphamide : 1.5 gm/m\^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.
Gastrointestinal disorders Nausea	84.4% 27/32 • 4 years and 5 months
Gastrointestinal disorders Diarrhea	62.5% 20/32 • 4 years and 5 months

Additional Information

Naoto Ueno, MD / Professor

University of Texas MD Anderson Cancer Center

Email: CR_Study_Registration@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place