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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03918317
• Other study ID #: CASE2119
• Status: Withdrawn
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: June 1, 2022

Study information

• Verified date: August 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Outcome

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