Safety Study of the Hypo-fractionated (Large Doses) Radiation Therapy in Post-menopausal Women With Breast Cancers

NCT02883985 | Completed Phase 1

• 1 other identifier: 9096
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Up to 5 years

Secondary Outcomes (2)

• TGF-beta 1 determinations

  From baseline to up to 4 weeks

• Ultrasound for target localization

  up to 4 weeks

Study Arms (1)

Radiation Therapy: 6 Gy/ fraction

EXPERIMENTAL

All patients will be treated with 6 Gy /fraction delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.

Radiation: 6 Gy/ fraction

Interventions

6 Gy/ fraction RADIATION

All patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy. In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment.

Radiation Therapy: 6 Gy/ fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Perlmutter Cancer Center

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 22494589 RESULT

Related Links

• Prone accelerated partial breast irradiation after breast-conserving surgery: five-year results of 100 patients

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Carmen Perez, M.D.

  NYU Perlmutter Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 30, 2016
• Study Start: May 1, 2000
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2017
• Last Updated: December 21, 2018

Record last verified: 2018-12

Locations

US (1)