A Study of the Use of AirXpanders AeroForm in Patients Undergoing Post-Mastectomy Radiation Therapy

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.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Device: AirXpanders AeroFormtissue expander

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AirXpanders AeroFormtissue expander + Radiation therapy; 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.

Device: AirXpanders AeroFormtissue expander; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of successful reconstructions following radiation therapy	up to 6 months following permanent implant placement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of implant success at 6months following replacement.		up to 6 months following permanent implant placement
Rate of reconstruction revisions from Aeroform placement throughout study.		up to 6 months following permanent implant placement
Time to implant exchange from Aeroform placement.		up to 6 months following permanent implant placement
Time to initiation of adjuvant chemotherapy following initial surgery (when applicable).		up to 6 months following permanent implant placement
Time to initiation of radiation therapy following initial surgery		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	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	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	up to 6 months following permanent implant placement
Number of participants who experience acute toxicity per CTCAE version 4.0	See AE/SAE section	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	up to 6 months following permanent implant placement

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Chirag Shah, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2019
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 15, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: CASE2119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Part of sponsored study, not planning to share IPD at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes