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

NCT03918317 | Withdrawn DMC FDA Device

• 1 other identifier: CASE2119
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of successful reconstructions following radiation therapy

  up to 6 months following permanent implant placement

Secondary Outcomes (10)

• 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

Study Arms (1)

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.

Device: AirXpanders AeroFormtissue expander

Interventions

AirXpanders AeroFormtissue expander DEVICE

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.

AirXpanders AeroFormtissue expander + Radiation therapy

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Female gender based on presentation of breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chirag Shah

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 17, 2019
• Study Start: July 15, 2019
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2022
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share