NCT00429507

Brief Summary

Primary objectives: \- To determine the time to progression in subjects with breast cancer metastatic to bone only treated with 153Sm-EDTMP and Autologous Peripheral Blood Stem Cell Transplantation (PBSCT). Secondary objectives:

  • To determine the overall survival at one year.
  • To determine the efficacy of 153Sm-EDTMP at 6 months.
  • To assess pain in subjects treated with 153Sm-EDTMP.
  • To determine the safety of 153Sm-EDTMP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Mar 2007

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2007

Completed
29 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 24, 2015

Completed
Last Updated

November 24, 2015

Status Verified

October 1, 2015

Enrollment Period

7.7 years

First QC Date

January 29, 2007

Results QC Date

October 22, 2015

Last Update Submit

October 22, 2015

Conditions

Breast CancerBone Metastases

Keywords

Breast CancerBlood Stem CellBone MetastasesRadiation TherapyGamma CameraSm-EDTMPSamarium 153-EDTMPStem Cell TransplantAutologous Peripheral Blood Stem Cell TransplantationPBSCTQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Time to Progression

    Time to progression is measured as the time from study entry to the development of disease progression.

    7.5 Years, Study period was March 2007 to November 2014.

Study Arms (1)

Samarium 153-EDTMP + Stem Cell Transplant

EXPERIMENTAL

Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose. Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP. Questionnaires taking about 15 minutes to complete.

Drug: 153 Sm-EDTMPBehavioral: QuestionnaireProcedure: Stem Cell Transplant

Interventions

153 Sm-EDTMPDRUG

Tracer dose = 30 mCi by vein On Day 1. If enough study drug goes to bones, will receive a higher dose of 153 Sm-EDTMP, called a therapy dose, 7-14 days after the tracer dose.

Also known as: Samarium 153-EDTMP
Samarium 153-EDTMP + Stem Cell Transplant
QuestionnaireBEHAVIORAL

Questionnaires taking about 15 minutes to complete.

Also known as: Survey
Samarium 153-EDTMP + Stem Cell Transplant
Stem Cell TransplantPROCEDURE

Stem Cell Transplant on Day 0, about 14-21 days after Samarium 153-EDTMP.

Also known as: SCT, Autologous Peripheral Blood Stem Cell Transplantation, PBSCT
Samarium 153-EDTMP + Stem Cell Transplant

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stage IV breast cancer metastatic to bone and/or bone marrow only.
  • Age between 18 and 65 years.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1
  • Subjects with breast tumors with hormone receptor positive disease (ER+/PR+, ER+/PR-, or ER-/PR+) must have failed at least one hormonal-based therapy for bone only disease.
  • Subjects with breast tumors with hormone receptor negative disease must have failed at least one anthracycline and/or taxane-based therapy for bone only disease.
  • White blood cell count (WBC) \>/= 3.5 x10\^9/L, Hb \>/= 10 g/dL, platelets \>/= 100 x10\^9/L.
  • Adequate pulmonary function defined as forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for hemoglobin) \>/= 50% of predicted.
  • Adequate cardiac function as evidenced by left ventricular ejection fraction (LVEF) of \>/= 45%.
  • Serum total bilirubin \< 2x upper limit of normal (ULN), and ALT/serum glutamate pyruvate transaminase (SGPT) \< 3x ULN
  • Creatinine clearance of \>/= 75 mL/min for subjects up to 50 years of age, and adjusted for age by a 10% decrease per decade for subjects of more than 50 years of age.
  • Ability to understand the study and provide informed consent.

You may not qualify if:

  • Any metastatic disease or history of metastatic disease other than skeletal metastases
  • Impending fracture, spinal cord compression, and/or potentially unstable compression fracture of vertebral body with possibility of cord compression.
  • Previous strontium-89 or samarium-153 treatment for any skeletal involvement.
  • Cumulative external beam radiation to \> 20% of marrow volume or \> 40 Gy to any single region of the spinal cord.
  • Prior radiation to the bladder or kidney, defined as radiation portals that directly include any volume of either kidney and/or the bladder.
  • Life expectancy severely limited by concomitant illness (less than 6 months).
  • Prior nephrectomy.
  • History of hemorrhagic cystitis obstructive uropathy or hydronephrosis.
  • Uncontrolled arrhythmia or symptomatic cardiac disease.
  • Current gross hematuria in urinalysis (UA) in the absence of vaginal bleeding.
  • Evidence of HIV-seropositivity.
  • Inability to stop any chemotherapy treatment for breast cancer within 3 weeks preceding high dose Samarium.
  • Use of any investigational agent within 30 days preceding enrollment.
  • Pregnant or lactating women.
  • Other current or prior malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and QuestionnairesStem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Nato Ueno, MD, PhD/Professor, Breast Medical Oncology
Organization
University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Naoto Ueno, MD, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2007

First Posted

January 31, 2007

Study Start

March 1, 2007

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

November 24, 2015

Results First Posted

November 24, 2015

Record last verified: 2015-10

Locations

US(1)