Breast CancerNCT03918317
A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy
A study testing AirXpanders AeroFormtissue expander in people with Breast Cancer, run by Case Comprehensive Cancer Center.
Trial summary
This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AirXpanders AeroFormtissue expander
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2019to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must have histologically of invasive breast cancer.
- Subjects must be planned for unilateral mastectomy
- Subjects must be planned for reconstruction. Pre-pectoral or sub-pectoral reconstruction allowed. Final reconstruction must be implant
- ECOG Performance status <2
- Subject must have features that will necessitate post-mastectomy radiation therapy:
- Tumors > 5 cm
Show all 14Show fewer
- Axillary node positive disease (pathologic confirmation)
- Clinical features prior to neoadjuvant chemotherapy to require post-mastectomy radiation therapy
- Recurrent disease without previous radiation
- Clinically node negative participants with positive SLN at surgery
- Internal mammary nodal involvement (clinical assessment)
- Subjects must have no clinical or radiographic evidence of distant metastases (imaging not required unless indicated as part of standard of care)
- Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving CT simulation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Subjects must have the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subjects with metastatic disease
- Subjects receiving any other investigational agents.
- Subjects treated with non-standard radiotherapy (hypofractionation, hyperfractionation, partial breast/axilla)
- Subjects with active infection requiring IV antibiotics
- Subject has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Subject has received prior radiation therapy to neck, breast, or chest or other area that will result in overlap.
- Pregnant or breastfeeding women or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last day of trial treatment are excluded from this study because of the potential toxicities of radiation therapy. Additionally, because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with AirXpanders, breastfeeding women will be excluded. These potential risks may also apply to other agents used in this study.
About this study
This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved.
Read the detailed description
Primary objective:
To assess the proportion of successful initial phase of tissue expander/implant based breast reconstructions (no reconstruction failure or unexpected return to the operating room) following post-mastectomy radiation therapy in participants with AeroFormplaced.
Secondary objectives:
- To evaluate the rate of successful exchange of tissue expander for implant
- To evaluate the rate of reconstruction revisions
- To evaluate CTCAE acute and chronic toxicity rates, infections and cosmetic outcomes
- To evaluate dosimetry to treatment targets as well as organs at risk (heart, lungs) with AeroFormas compared to traditional reconstruction techniques.
- To evaluate time to initiation of chemotherapy and/or radiotherapy.
- To evaluate clinical outcomes-local recurrence, regional recurrence, distant metastases, survival
- To evaluate participant breast reconstruction related QOL with the AirXpander AeroFormdevice
This is a phase II trial evaluating the use of the intervention in participants with breast cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile and associated subsequent successful surgical reconstruction rate
- Conditions
- Breast Cancer
- Being tested
- AirXpanders AeroFormtissue expander
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirXpanders AeroFormtissue expanderDevice
The AeroFormdevice will be placed in an immediate fashion at the time of mastectomy in a submuscular, prepectoral or dual-plane approach. The tissue expander will be minimally inflated intraoperatively to minimize dead space and while facilitating tension free closure. Participants will undergo standard postoperative management, and will be given instructions on utilization of the device, including daily expansion until desired volume is reached as determined b surgeon and participant agreement.
| Study group | Role | What they receive |
|---|---|---|
| AirXpanders AeroFormtissue expander + Radiation therapy | Experimental | AirXpanders AeroFormtissue expander in participants with breast cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile and associated subsequent successful surgical reconstruction rate. Receives: Device: AirXpanders AeroFormtissue expander |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful reconstructions following radiation therapy
Measured: up to 6 months following permanent implant placement
Secondary outcomes (10)
Rate of implant success at 6months following replacement.
Measured: up to 6 months following permanent implant placement
Rate of reconstruction revisions from Aeroform placement throughout study.
Measured: up to 6 months following permanent implant placement
Time to implant exchange from Aeroform placement.
Measured: up to 6 months following permanent implant placement
Time to initiation of adjuvant chemotherapy following initial surgery (when applicable).
Measured: up to 6 months following permanent implant placement
Time to initiation of radiation therapy following initial surgery
Measured: up to 6 months following permanent implant placement
Cosmetic outcomes per the aesthetics scale
13-question assessment with scores ranging from 13 - 65, higher scores indicating better aesthetics
Measured: up to 6 months following permanent implant placement
Quality of life based on the BREAST-Q scales
Full name BREAST-Q- Reconstruction Module version 2.0, higher is better outcome
Measured: up to 6 months following permanent implant placement
Quality of life based on the Breast satisfactions scales
Full name BREAST-Q- Reconstruction Module version 2.0, higher is better outcome
Measured: up to 6 months following permanent implant placement
Number of participants who experience acute toxicity per CTCAE version 4.0
See AE/SAE section
Measured: up to 6 months following permanent implant placement
Chronic toxicity per CTCAE, Baker scoring
Full name CTCAE Toxicity/Baker Capsular Contracture, Higher- worse CTCAE and Baker
Measured: up to 6 months following permanent implant placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start15 Jul 2019 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: Funding unavailable - Company shutting down
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chirag Shah, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918317
- Sponsor's protocol ID
- CASE2119
- Status last verified
- Aug 2019
- First submitted
- 15 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Part of sponsored study, not planning to share IPD at this time.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy
- ClinicalTrials.gov ID
- NCT03918317
- Acronym / sponsor ID
- CASE2119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable - Company shutting down
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 15 Jul 2019 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 17 Apr 2019 (actual)
- 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.
This study seeks to to determine the efficacy and side effect profile following radiation therapy for participants with the AeroForm device placed. The AeroForm device is FDA approved.
Detailed description
Primary objective:
To assess the proportion of successful initial phase of tissue expander/implant based breast reconstructions (no reconstruction failure or unexpected return to the operating room) following post-mastectomy radiation therapy in participants with AeroFormplaced.
Secondary objectives:
- To evaluate the rate of successful exchange of tissue expander for implant
- To evaluate the rate of reconstruction revisions
- To evaluate CTCAE acute and chronic toxicity rates, infections and cosmetic outcomes
- To evaluate dosimetry to treatment targets as well as organs at risk (heart, lungs) with AeroFormas compared to traditional reconstruction techniques.
- To evaluate time to initiation of chemotherapy and/or radiotherapy.
- To evaluate clinical outcomes-local recurrence, regional recurrence, distant metastases, survival
- To evaluate participant breast reconstruction related QOL with the AirXpander AeroFormdevice
This is a phase II trial evaluating the use of the intervention in participants with breast cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile and associated subsequent successful surgical reconstruction rate
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AirXpanders AeroFormtissue expander + Radiation therapy | Experimental | Device: AirXpanders AeroFormtissue expanderAirXpanders AeroFormtissue expander in participants with breast cancer undergoing post-mastectomy radiation therapy in order to define the toxicity profile and associated subsequent successful surgical reconstruction rate. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Subjects must have histologically of invasive breast cancer.
- Subjects must be planned for unilateral mastectomy
- Subjects must be planned for reconstruction. Pre-pectoral or sub-pectoral reconstruction allowed. Final reconstruction must be implant
- ECOG Performance status <2
- Subject must have features that will necessitate post-mastectomy radiation therapy:
Key exclusion criteria (8 listed)
- Subjects with metastatic disease
- Subjects receiving any other investigational agents.
- Subjects treated with non-standard radiotherapy (hypofractionation, hyperfractionation, partial breast/axilla)
- Subjects with active infection requiring IV antibiotics
- Subject has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
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 |
|---|---|---|
| AirXpanders AeroFormtissue expanderThe AeroFormdevice will be placed in an immediate fashion at the time of mastectomy in a submuscular, prepectoral or dual-plane approach. The tissue expander will be minimally inflated intraoperatively to minimize dead space and while facilitating tension free closure. Participants will undergo standard postoperative management, and will be given instructions on utilization of the device, including daily expansion until desired volume is reached as determined b surgeon and participant agreement. | Device | AirXpanders AeroFormtissue expander + Radiation therapy |
Primary outcome
Rate of successful reconstructions following radiation therapy
Time frame: up to 6 months following permanent implant placement
10 secondary outcomes
Rate of implant success at 6months following replacement.
Time frame: up to 6 months following permanent implant placement
Rate of reconstruction revisions from Aeroform placement throughout study.
Time frame: up to 6 months following permanent implant placement
Time to implant exchange from Aeroform placement.
Time frame: up to 6 months following permanent implant placement
Time to initiation of adjuvant chemotherapy following initial surgery (when applicable).
Time frame: up to 6 months following permanent implant placement
Time to initiation of radiation therapy following initial surgery
Time frame: up to 6 months following permanent implant placement
Cosmetic outcomes per the aesthetics scale
Time frame: up to 6 months following permanent implant placement
Quality of life based on the BREAST-Q scales
Time frame: up to 6 months following permanent implant placement
Quality of life based on the Breast satisfactions scales
Time frame: up to 6 months following permanent implant placement
Number of participants who experience acute toxicity per CTCAE version 4.0
Time frame: up to 6 months following permanent implant placement
Chronic toxicity per CTCAE, Baker scoring
Time frame: up to 6 months following permanent implant placement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No. Part of sponsored study, not planning to share IPD at this time.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Chirag Shah principal investigator
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing AirXpanders AeroFormtissue expander in people with Breast Cancer, run by Case Comprehensive Cancer Center.
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 14 inclusion and 8 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: withdrawn, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of successful reconstructions following radiation therapy (time frame: up to 6 months following permanent implant placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.