Invasive Ductal CarcinomaNCT01644669
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
A study testing Intra-operative Radiation Therapy - IORT in people with Invasive Ductal Carcinoma and Ductal Carcinoma in Situ, run by Xoft, Inc. at 24 sites in 3 countries.
Trial summary
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Invasive Ductal Carcinoma, Ductal Carcinoma in Situ
- What is being tested?
- Intra-operative Radiation Therapy - IORT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 8 May 2012to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have provided written Informed Consent
- Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
- Subject must be female ≥ 40 years of age
- Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
- Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
- Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
- Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
- Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
Who cannot join
- Subject is pregnant or nursing
- Subject has significant auto-immune disease
- Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
- Subject has biopsy-proven multifocal breast cancer
- Subject has multi-centric breast cancer
- Subject has known lympho-vascular invasion
Show all 14Show fewer
- Subject has invasive lobular cancer
- Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
- Subject has a history of recurrent breast cancer in the ipsilateral breast
- Subject has had previous radiation exposure of the involved breast
- Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
- Subject has contraindications for radiation
- Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
- Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT.
Trial locations and contacts
24 sites in 3 countries.
24 sites in 3 countries
United States22 sites
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
MedStar Oncology Network - Good Samaritan Hospital
Baltimore, Maryland, 21218
MedStar Oncology Network - Franklin Square
Baltimore, Maryland, 21237
Florida Hospital Celebration Health
Celebration, Florida, 34747
Parkridge Medical Center
Chattanooga, Tennessee, 37404
Rush University
Chicago, Illinois, 60612
Doctors Hospital
Coral Gables, Florida, 33146
Western Surgical Care, PC
Denver, Colorado, 80220
City of Hope
Duarte, California, 91010
Swedish Medical Center
Englewood, Colorado, 80113
Exeter Hospital
Exeter, New Hampshire, 03833
Lutheran Hospital of Indiana
Fort Wayne, Indiana, 46804
Long Beach Memorial Medical Center
Long Beach, California, 90806
UCLA
Los Angeles, California, 90095
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37212
Tri-City Medical Center
Oceanside, California, 92056
University of Oklahoma
Oklahoma City, Oklahoma, 73104
Diablo Valley Oncology Hematology Medical Group
Pleasant Hill, California, 94523
Staten Island University Hospital
Staten Island, New York, 10305
Martin Health System Center for Clinical Research
Stuart, Florida, 34994
University of Arizona
Tucson, Arizona, 85704
Sentara Northern Virginia Medical Center
Woodbridge, Virginia, 22191
Australia1 site
Monash Health / Peter MacCallum Cancer Centre
Clayton, Victoria, 3165
About this study
Official title: A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx® System® at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.
Read the detailed description
The rationale for IORT as the sole radiation therapy is:
Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted alternative to whole breast irradiation following breast-conserving surgery for early stage breast cancer. Intra-Operative Radiation Therapy (IORT) is a form of APBI that allows radiation to be delivered directly to the open tumor bed following Breast Conservation Surgery (BCS). After 4 years of follow-up, IORT has shown equivalent disease control rates as whole breast irradiation.
Direct and timely radiation to the tumor bed: Radiation is delivered at to the target tissue (adjacent to the resection margins at the time of lumpectomy). It avoids treatment delays and eliminates weeks or months of post-surgical radiation therapy during which residual cancer cells might proliferate. An in vitro study showed that un-irradiated wound fluid stimulated the growth of breast cancer cells while irradiated wound fluid did not. Each month of delay in radiation treatment is associated with a 1% increase in the recurrence rate. Huang, et al., found a 5.8% recurrence rate in patients who received WBRT within 8 weeks of BCS compared with a 9.1% recurrence rate in patients who started radiotherapy 9-16 weeks after BCS.
Increased patient treatment compliance compared to conventional radiation therapy: Suitable early stage breast cancer patients are able to complete their breast cancer radiotherapy treatment at the time of BCS, which offers a convenient and potentially life-saving benefit to patients who might otherwise omit radiation therapy if it required lengthy travel or time commitments. In addition, healthcare resources, including both personnel and facilities, will be conserved by eliminating the overhead cost of multiple patient visits, eliminating waiting time for patients, and consolidating therapy to one visit combined with the surgical procedure.
Available Technology: The Xoft Axxent controller, x-ray source, and balloon applicator are cleared by the United States Food and Drug Administration (FDA) to deliver brachytherapy treatments using high dose rate x-ray radiation. The Xoft Axxent System has been used to treat breast cancer subjects using a multi-fraction APBI technique on an outpatient basis as part of two multi-center studies. The Xoft Axxent System enables the Radiation Oncologist to administer electronic brachytherapy without the use of a radioactive isotope in minimally shielded rooms. Characteristics of the Xoft System that make it well-suited for IORT include its portability and low energy photons, allowing for minimal shielding during the radiation therapy.
This protocol has been developed to further study the use of the Xoft Axxent eBx System in the delivery of IORT for subjects with early-stage breast cancer. The Xoft Axxent eBx System will be used according to the United States Food and Drug Administration (FDA) 510(k) cleared labeling; therefore, the use of the technology in this study is considered on-label and within the scope of the FDA cleared indication.
- Being tested
- Intra-operative Radiation Therapy - IORT
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative Radiation Therapy - IORTRadiation
Also called Electronic Brachytherapy
Single dose of 20 Gy
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative Radiation Therapy - IORT | Experimental | Intra-operative Radiation Therapy Receives: Radiation: Intra-operative Radiation Therapy - IORT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.
Measured: Change from baseline reported at 5 years
Secondary outcomes (6)
Assess the rate of regional breast tumor recurrence (RBTR)
Regional breast tumor recurrence is defined as biopsy-proven reappearance of cancer in the axilla. Regional recurrence will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. Regional recurrence rates will be compared to the historical control of WBI at 5 and 10 years.
Measured: Report at 10 yrs
Disease Free Survival Rate (DFSR) and Overall Survival rate
Disease free survival (DFS) is defined as the length of time from IORT to any first recurrence. The incidence of disease free survival will be assessed at Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. DFS will be compared to the historical control at 5 and 10 years.
Measured: Report at 5 and 10 years
Cosmetic Outcome
Cosmetic outcome will be recorded at baseline, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. a. Physician evaluation will be done using the Harvard Scale.
Measured: Report at 5 and 10 yrs
Quality of Life (QOL)
Quality of Life will be assessed at baseline and at each follow-up visit: Month 1, Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. QOL will be measured using the FACT-B self-reporting questionnaires.
Measured: Reported at 5 and 10 yrs
Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer
The rates and severity of Adverse Events (AEs), Adverse Device Effects (ADEs), and Unanticipated Adverse Device Effects (UADEs) during and following IORT will be assessed at each follow-up visit. Safety events will be compared to the historical control of WBI at 5 and 10 years. Each event will be classified according to the following: Device Related, Procedure Related or Radiation Related.
Measured: On-going monitoring, report at 5 and 10 years
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years
IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 10 years.
Measured: Change from baseline reported at 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2012 (estimated)
- Study start8 May 2012
- Primary completion12 Jul 2023
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Invasive Ductal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single 20Gy dose of electronic brachytherapy (IORT)
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xoft, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icad, Inc.
- Responsible party
- Sponsor
- Investigators
- A.M. Nisar Syed, MD, Principal investigator, Long Beach Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01644669
- Sponsor's protocol ID
- CTPR-0009
- Status last verified
- Jan 2025
- First submitted
- 28 Jun 2012
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No IPD will be shared.
Publications
Ivanov O, Dickler A, Lum BY, Pellicane JV, Francescatti DS. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb;18(2):453-8. doi: 10.1245/s10434-010-1283-x. Epub 2010 Aug 25.
PubMed 20737219Dickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2;7:24. doi: 10.1186/1477-7819-7-24.
PubMed 19254369
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft® Axxent® eBx® System® at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01644669
- Acronym / sponsor ID
- CTPR-0009
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Xoft, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Icad, Inc.
- Study start
- 8 May 2012 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 19 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer. Hypothesis: IORT using the Xoft Axxent eBx System is no worse (non-inferior) than whole breast irradiation (WBI) when used as stand-alone radiation treatment in breast conserving therapy in women with early stage breast cancer.
Detailed description
The rationale for IORT as the sole radiation therapy is:
Favorable preliminary results in feasibility, safety and efficacy outcomes: Accelerated Partial Breast Irradiation (APBI) is an accepted alternative to whole breast irradiation following breast-conserving surgery for early stage breast cancer. Intra-Operative Radiation Therapy (IORT) is a form of APBI that allows radiation to be delivered directly to the open tumor bed following Breast Conservation Surgery (BCS). After 4 years of follow-up, IORT has shown equivalent disease control rates as whole breast irradiation.
Direct and timely radiation to the tumor bed: Radiation is delivered at to the target tissue (adjacent to the resection margins at the time of lumpectomy). It avoids treatment delays and eliminates weeks or months of post-surgical radiation therapy during which residual cancer cells might proliferate. An in vitro study showed that un-irradiated wound fluid stimulated the growth of breast cancer cells while irradiated wound fluid did not. Each month of delay in radiation treatment is associated with a 1% increase in the recurrence rate. Huang, et al., found a 5.8% recurrence rate in patients who received WBRT within 8 weeks of BCS compared with a 9.1% recurrence rate in patients who started radiotherapy 9-16 weeks after BCS.
Increased patient treatment compliance compared to conventional radiation therapy: Suitable early stage breast cancer patients are able to complete their breast cancer radiotherapy treatment at the time of BCS, which offers a convenient and potentially life-saving benefit to patients who might otherwise omit radiation therapy if it required lengthy travel or time commitments. In addition, healthcare resources, including both personnel and facilities, will be conserved by eliminating the overhead cost of multiple patient visits, eliminating waiting time for patients, and consolidating therapy to one visit combined with the surgical procedure.
Available Technology: The Xoft Axxent controller, x-ray source, and balloon applicator are cleared by the United States Food and Drug Administration (FDA) to deliver brachytherapy treatments using high dose rate x-ray radiation. The Xoft Axxent System has been used to treat breast cancer subjects using a multi-fraction APBI technique on an outpatient basis as part of two multi-center studies. The Xoft Axxent System enables the Radiation Oncologist to administer electronic brachytherapy without the use of a radioactive isotope in minimally shielded rooms. Characteristics of the Xoft System that make it well-suited for IORT include its portability and low energy photons, allowing for minimal shielding during the radiation therapy.
This protocol has been developed to further study the use of the Xoft Axxent eBx System in the delivery of IORT for subjects with early-stage breast cancer. The Xoft Axxent eBx System will be used according to the United States Food and Drug Administration (FDA) 510(k) cleared labeling; therefore, the use of the technology in this study is considered on-label and within the scope of the FDA cleared indication.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single 20Gy dose of electronic brachytherapy (IORT)
| Arm | Type | Receives |
|---|---|---|
| Intra-operative Radiation Therapy - IORT | Experimental | Radiation: Intra-operative Radiation Therapy - IORTIntra-operative Radiation Therapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must have provided written Informed Consent
- Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
- Subject must be female ≥ 40 years of age
- Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
- Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
Key exclusion criteria (14 listed)
- Subject is pregnant or nursing
- Subject has significant auto-immune disease
- Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
- Subject has biopsy-proven multifocal breast cancer
- Subject has multi-centric breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-operative Radiation Therapy - IORTAlso: Electronic BrachytherapySingle dose of 20 Gy | Radiation | Intra-operative Radiation Therapy - IORT |
Primary outcome
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years
Time frame: Change from baseline reported at 5 years
IBTR is defined as biopsy-proven reappearance of cancer in the treated breast. IBTR will be assessed at Month 6, Month 12, Month 18, Year 2, and then annually through ten (10) year follow-up. A non-inferiority comparison to whole breast irradiation will be made at 5 years.
6 secondary outcomes
Assess the rate of regional breast tumor recurrence (RBTR)
Time frame: Report at 10 yrs
Disease Free Survival Rate (DFSR) and Overall Survival rate
Time frame: Report at 5 and 10 years
Cosmetic Outcome
Time frame: Report at 5 and 10 yrs
Quality of Life (QOL)
Time frame: Reported at 5 and 10 yrs
Assess the safety of single fraction IORT at the time of breast conserving surgery for early stage breast cancer
Time frame: On-going monitoring, report at 5 and 10 years
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 10 years
Time frame: Change from baseline reported at 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 20737219Ivanov O, Dickler A, Lum BY, Pellicane JV, Francescatti DS. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb;18(2):453-8. doi: 10.1245/s10434-010-1283-x. Epub 2010 Aug 25.
- Background: PubMed 19254369Dickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2;7:24. doi: 10.1186/1477-7819-7-24.
- National Cancer Institute Factsheet - Radiation Therapy for CancerLink provided by the sponsor.
- Individual participant dataSharing planned: No. No IPD will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A.M. Nisar Syed, MD principal investigator
Long Beach Memorial Medical Center
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative Radiation Therapy - IORT in people with Invasive Ductal Carcinoma and Ductal Carcinoma in Situ, run by Xoft, Inc. at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the rate of ipsilateral breast tumor recurrence (IBTR) at 5 years (time frame: Change from baseline reported at 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01644669, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.