NCT02052102

Brief Summary

The study hopes to determine whether patients with left-sided breast cancer are at an increased risk of cardiac changes due to radiation to the breast +/- Anthracycline-based chemotherapy +/- Herceptin and whether a deep inspiration breath hold (DIBH) technique during radiotherapy treatments would further reduce dosimetric dose to the heart as compared to the conventional free breathing (FB) technique thus reducing cardiac toxicity as measured by cardiac MRI using left ventricular end-diastolic volume (LVEDV) as a metric. Bio fluid samples will also be collected to investigate specific biomarkers of breast cancer: BNP, PIIINP and CITP

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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 24, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.3 years

First QC Date

January 24, 2014

Last Update Submit

January 4, 2017

Conditions

Breast CancerAdverse Effect of Radiation Therapy

Keywords

Deep inspiration breath holdradiation therapyCardiac toxicityLeft-sided breast cancer

Outcome Measures

Primary Outcomes (1)

  • Radiation related acute and long term functional changes in patients treated with deep-inspiration breath hold compared to free-breathing technique

    Using MRI-based cardiac functional imaging to measure radiation-related acute and long term cardiac functional changes in patients treated with deep-inspiration breath-hold (DIBH) compared to free breathing (FB) treatment

    12 months

Secondary Outcomes (1)

  • Radiation dosimetric comparison

    12 months

Study Arms (3)

No prior therapy, DIBH irradiation

ACTIVE COMPARATOR

Cohort 1 - No prior anthracycline-based chemotherapy or herceptin, deep inspiration breath hold breast radiation therapy

Radiation: Radiation therapy

No prior therapy, FB technique

ACTIVE COMPARATOR

Cohort II - no prior Anthracycline based chemotherapy or Herceptin and (ii) to receive FB RT (not able to hold breath for at least 20 seconds or does not have a minimum of 1.0 cm of heart on at least 3 slices (3mm slices) on the FB scan)

Radiation: Radiation therapy

Prior therapy, DIBH irradiation

ACTIVE COMPARATOR

Cohort III - Prior Anthracycline-based chemotherapy or Herceptin, and (ii) eligible to receive DIBH RT. (Patient has a minimum of 1.0 cm of heart on at least 3 slices (3mm slices) on the FB scan)

Radiation: Radiation therapy

Interventions

Radiation therapyRADIATION
No prior therapy, DIBH irradiationNo prior therapy, FB techniquePrior therapy, DIBH irradiation

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients with pathologically confirmed left sided breast cancer eligible for adjuvant breast/chest wall plus or minus regional nodal radiotherapy
  • Women patients with age group between 18 and 70 years old
  • Karnofsky performance score ≥ 70
  • Ability to hold breath for at least 20 sec (for DIBH cohorts only)
  • Life expectancy \>10 years

You may not qualify if:

  • For patients with prior Anthracycline based chemotherapy or Herceptin, if there is \< 1.0 cm of heart on at least 3 slices ( 3 mm slices) on the FB scan, the patient will be considered a screen failure.
  • Previously irradiated or recurrent breast/chest wall tumours or previous malignancy other than non-melanoma skin cancer unless disease free for a minimum of 5 years prior to study entry
  • Patients that require a shell for breast immobilization
  • Patients requiring a boost
  • Stage IV disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRadiation InjuriesCardiotoxicityUnilateral Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesWounds and InjuriesHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC

    Cross Cancer Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kurian Joseph, MB, FFRRCSI, FRCR, FRCPC

CONTACT

780-432-8755kurian.joseph@albertahealthservices.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2014

First Posted

January 31, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

January 6, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)