Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

Stage IA Breast Cancer Clinical Trial

Official title:

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01570998
• Other study ID #: 117515
• Secondary ID: NCI-2017-00461
• Status: Recruiting
• Phase: N/A
• Start date: May 18, 2012
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: University of California, San Francisco
• Contact: Catherine Dugan
• Phone: 415-502-8910
• Email: Catherine.Dugan[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Description:

PRIMARY OBJECTIVES:

I. To establish eligibility criteria based on previously published trials and studies in order to allow women who meet these criteria to receive intraoperative radiation therapy (IORT) on an Institutional Review Board (IRB)-approved protocol.

II. To systematically collect and assess acute and long-term toxicity and outcomes in larger cohort of patients.

III. To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation, as indicated by pathologic risk factors, in women with early stage breast cancer.

IV. In-breast local failure and patterns of in-breast failure. V. Ipsilateral regional nodal failure. VI. Toxicity and morbidity. VII. Relapse-free survival. VIII. Overall survival.

OUTLINE:

Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.

After completion of study treatment, patients are followed up within 6 weeks and then every 6 months for 3 years and yearly for 2 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• Suitable for breast conserving surgery

• T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

• Axillary lymph node positive breast cancer

• Tumor size > 3.5 cm

• Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen

• Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy

• Inability to assess pathologic margin status

• Synchronous bilateral breast cancer at the time of diagnosis

• Ipsilateral breast had a previous cancer and/or prior in-field radiation

• Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)

• Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size

• Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater

• Any factor included as exclusion criteria in the participating center's treatment policy statement

• Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):

• Patients under the age of 50

• Estrogen receptor negative (as defined in Treatment Policy under "Pathology")

• Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")

• Lymphovascular invasion

• High grade

• Tumors > 3 cm

• Node positive patients

• Prior chemotherapy or hormone therapy

Related Conditions & MeSH terms

• Breast Neoplasms
• Stage IA Breast Cancer
• Stage IIA Breast Cancer

Intervention

Radiation:
• Intraoperative Radiation Therapy
Undergo IORT

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Alta Bates Summit Medical Center-Herrick Campus	Berkeley	California
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Community Hospital at Dobbs Ferry	Dobbs Ferry	New York
United States	Saint Luke's Hospital-Anderson Campus	Easton	Pennsylvania
United States	Inova Fairfax Hospital Cancer Center	Fairfax	Virginia
United States	Cleveland Clinic	Fort Lauderdale	Florida
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	Aurora BayCare Medical Center	Green Bay	Wisconsin
United States	Greenwich Hospital	Greenwich	Connecticut
United States	Community Cancer Center South	Indianapolis	Indiana
United States	University of California, Irvine	Irvine	California
United States	Cornell University	Ithaca	New York
United States	Dignity Health - California Hospital Medical Center	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Columbia University/Herbert Irving Cancer Center	New York	New York
United States	Sentara Port Warwick	Newport News	Virginia
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Marie Yeager Cancer Center, Spectrum Health Lakeland	Saint Joseph	Michigan
United States	University of California, San Francisco	San Francisco	California
United States	Memorial Health University Medical Center	Savannah	Georgia
United States	John Muir Medical Center-Walnut Creek	Walnut Creek	California
United States	MedStar Georgetown University Hospital	Washington	District of Columbia
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Carl Zeiss Meditec AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of local recurrence	Local tumor control is defined as no recurrent tumor in the ipsilateral breast. Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. The two patient cohorts will not be separated for the analysis regarding local control.	Up to 5 years
Primary	Frequency of site of relapse within the breast	Site of relapse within the breast will be recorded in order to assess whether the recurrence is at the site of initial tumor or at a new site and whether it has occurred within the treated field (IORT).	Up to 5 years
Primary	Percentage of participants with treatment-related adverse events	Local toxicity and morbidity will be recorded as adverse events related to the primary treatment of the breast cancer. These were recorded in the randomized trial and outcomes showed no significant difference in clinical complications for the IORT as compared to standard external beam radiation. However, all expected toxicities of hematoma, seroma, wound infection, wound breakdown and delayed wound healing will be assessed according to Radiation Therapy Oncology Group (RTOG) criteria. Late skin reactions, rash, telangiectasia and pain due to radiation and all other toxicities will be recorded and graded according to standard NCI-CTCAE V. 4 criteria	Up to 5 years
Primary	Median Relapse-free survival	Relapse-free survival will be recorded as the time interval between trial entry and the date of confirmation of any recurrence. The actual date to be used is the clinic day on which the investigations that led to a confirmed diagnosis of the recurrence were requested. Relapse-free survival would include any recurrence of breast cancer (local, regional or distant) or death without prior report a relapse. All patients will be analyzed under an "Intent to Treat" policy	Up to 5 years
Primary	Median Overall Survival	Overall survival will be the time interval between enrollment and death.	Up to 5 years