Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy

SenoRx

Status and phase

Terminated

Phase 4

Conditions

Breast Cancer

Treatments

Device: Conture Multi-Lumen Balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT00699101

SENORX-S07-002

Details and patient eligibility

About

This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.

Full description

Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.

Enrollment

342 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Able and willing to sign informed consent
Age 50 or older at diagnosis
Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
1. sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
2. axillary dissection (minimum of six axillary nodes removed); and
3. the axillary node(s) must be pathologically negative.
The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
Estrogen receptor positive tumor

Exclusion criteria

Age < 50 at diagnosis (regardless of histology)
Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
Active collagen-vascular disease
Paget's disease of the breast
History of DCIS or invasive breast cancer
Prior breast or thoracic RT for any condition
Multicentric carcinoma (DCIS or invasive)
Synchronous bilateral invasive or non-invasive breast cancer
Surgical margins that cannot be microscopically assessed or that are positive or close
Positive axillary node(s)
T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
Estrogen receptor negative tumor