Clinical trial NCT03918317: A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy
Official title: A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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
* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rate of successful reconstructions following radiation therapy
timeFrame: up to 6 months following permanent implant placement
Secondary outcomes:
measure: Rate of implant success at 6months following replacement.
timeFrame: up to 6 months following permanent implant placement
measure: Rate of reconstruction revisions from Aeroform placement throughout study.
timeFrame: up to 6 months following permanent implant placement
measure: Time to implant exchange from Aeroform placement.
timeFrame: up to 6 months following permanent implant placement
measure: Time to initiation of adjuvant chemotherapy following initial surgery (when applicable).
timeFrame: up to 6 months following permanent implant placement
measure: Time to initiation of radiation therapy following initial surgery
timeFrame: up to 6 months following permanent implant placement
measure: Cosmetic outcomes per the aesthetics scale
timeFrame: up to 6 months following permanent implant placement
measure: Quality of life based on the BREAST-Q scales
timeFrame: up to 6 months following permanent implant placement
measure: Quality of life based on the Breast satisfactions scales
timeFrame: up to 6 months following permanent implant placement
measure: Number of participants who experience acute toxicity per CTCAE version 4.0
timeFrame: up to 6 months following permanent implant placement
measure: Chronic toxicity per CTCAE, Baker scoring
timeFrame: up to 6 months following permanent implant placement
Other outcomes:
Locations:
Study officials:
affiliation: The Cleveland Clinic
name: Chirag Shah
role: PRINCIPAL_INVESTIGATOR
References: