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Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial


Phase 2
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Safety and Feasibility of Short-course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial


OBJECTIVES:

Primary

- To determine local disease control in women with early-stage breast cancer treated with
shorter courses of accelerated partial-breast radiotherapy (APBI) delivered with a
breast brachytherapy applicator.

Secondary

- To determine whether the acceptable toxicity rates of APBI can be preserved when
further accelerating the dose delivery scheme from the commonly applied ten treatments
delivered twice daily over 5 days to two treatments delivered over 2 days.

- To assess the rate of excellent or good cosmesis at 3 years after shorter courses of
APBI.

- To identify covariants associated with and predictive of poor cosmetic outcome in
patients treated with an overnight course of APBI.

OUTLINE: This is a multicenter study.

Patients undergo placement of the Contura™ MLB device into the lumpectomy cavity followed by
CT scan for treatment planning. Approximately 1-5 days after balloon placement, patients
undergo accelerated partial-breast radiotherapy twice daily over 2 days.

After completion of study therapy, patients are followed up periodically for 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed ductal carcinoma in situ (DCIS) and/or invasive breast
cancer

- Stage Tis, T1, or T2 disease

- T2 tumor must be ≤ 3.0 cm in maximum diameter

- Must have undergone lumpectomy as surgical treatment of the breast

- Negative surgical margins by histology per NSABP criteria

- No surgical margins that cannot be microscopically assessed

- Patients with invasive breast cancer must have undergone an axillary staging
procedure by sentinel node biopsy alone or axillary dissection (with ≥ 6
axillary nodes removed)

- Axillary node(s) must be pathologically negative

- No Paget disease of the breast

- No prior DCIS or invasive breast cancer

- No multicentric carcinoma (DCIS or invasive)

- No synchronous bilateral invasive or non-invasive breast cancer

- Hormone-receptor status meeting 1 of the following criteria:

- Estrogen receptor (ER) positive tumor

- ER negative and progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Life expectancy > 10 years (excluding diagnosis of breast cancer)

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No active collagen vascular disease

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior breast or thoracic radiotherapy for any condition

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Locoregional failure rate at 3 years

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Atif Khan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey

Authority:

United States: Institutional Review Board

Study ID:

040902

NCT ID:

NCT01019720

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903