Clinical trial NCT02883985: Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers
Official title: Hypo-Fractionated Conformal Radiation Therapy to the Tumor Bed After Segmental Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether high dose of radiation therapy (RT) are effective over standard 6-week radiation treatment in patients with breast cancer

Detailed description: Hypo-fractionation (several large fractions as the only radiation treatment) for breast cancer irradiation was common in the forties and 50s and, while very successful in achieving tumor control, was found to leave significantly inferior cosmetic results due to severe fibrosis and telangiectasia compared to those obtained with multiple fraction regimens (38-40). These complications were due to the use of very large fields, with the inclusion of a large proportion of uninvolved skin and tissue surrounding the tumor.

Based on these assumptions, a few large fractions can be safely delivered to breast cancers provided that 1) the target volume is sufficiently small and 2) the radiation technique assures maximum sparing of the surrounding normal tissue. Conformal RT to the tumor bed of T1 breast cancers satisfies both requirements.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women (at least 2 years without menstrual period):

hysterectomized patients need follicle-stimulating hormone (FSH) confirmation of post-menopausal status.

* Original tumor non-palpable (mammographically detected).
* Small primary tumor (pT1) breast cancer, excised with negative margins (defined as at least a 5 mm margin).
* N0 or sentinel node negative or N0 clinically if the tumor is \<1 cm in size.
* Patient offered six weeks of post-segmental mastectomy conventional radiation therapy and declined.
* Prescribed antihormonal therapy as part of their management.

Exclusion Criteria:

* Previous radiation therapy to the ipsilateral breast.
* Presence of a proportion of ductal carcinoma in situ (DCIS) in the pathology specimen which is compatible with extensive intraductal component (EIC).
* Women incapable of providing their own consent. Mental status will be assessed by the Principal Investigator using the Radiation Therapy Oncology Group (RTOG) Mini-Mental Status Examination.
* Women with a diagnosis of multifocal breast cancer.

Primary outcomes:
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 5 years
Secondary outcomes:
measure: TGF-beta 1 determinations
timeFrame: From baseline to up to 4 weeks
measure: Ultrasound for target localization
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Perlmutter Cancer Center
state: New York
Study officials:
affiliation: NYU Perlmutter Cancer Center
name: Carmen Perez, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Formenti SC, Hsu H, Fenton-Kerimian M, Roses D, Guth A, Jozsef G, Goldberg JD, Dewyngaert JK. Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):606-11. doi: 10.1016/j.ijrobp.2012.01.039. Epub 2012 Apr 9.