Intensity Modulated Accelerated Partial Breast Irradiation Before Surgery in Treating Older Patients With Hormone Responsive Stage 0-I Breast Cancer

Stage IB Breast Cancer Clinical Trial

Official title:

Feasibility of Assessing Radiation Response With MRI/CT Directed Preoperative Accelerated Partial Breast Irradiation in the Prone Position for Hormone Responsive Early Stage Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02186470
• Other study ID #: OSU-13282
• Secondary ID: NCI-2014-01248
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 29, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot clinical trial studies intensity-modulated accelerated partial breast irradiation (APBI) before surgery in treating older patients with estrogen receptor positive or progesterone receptor positive stage I breast cancer. APBI is a specialized type of radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Description:

PRIMARY OBJECTIVES:

Establish the feasibility for preoperative APBI delivered with IMRT in the prone position using daily CT guidance for Stage I breast cancer patients who are intended to undergo a lumpectomy for breast conserving therapy.

SECONDARY OBJECTIVES:

1. To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.

2. To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.

3. Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.

4. Evaluate molecular changes in breast cancer and/or stroma before and after preoperative APBI

OUTLINE:

Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.

After completion of treatment, patients are followed up at 4 weeks and then every 6 months for 5 years.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.

• Patient must be = 50 years

• Core biopsy demonstrating breast cancer and receptors that are ER or PR positive.

• Core tissue must have HER 2 negative followed by current ASCO/CAP guidelines.

• The patient must have clinical node negative, stage I breast cancer.

• The surgical treatment must be intended to be a lumpectomy

• The biopsy site must have been demarcated by a clip(s)

• Gross disease must be unifocal on Mammo/ MRI imaging

• Patients must have estrogen receptor (ER) and progesterone receptor (PR) analysis performed on core biopsy

• Patient must be able to tolerate lying in the prone position with arms extended forward.

• Must be able to tolerate MRI scan with contrast

• At the time of enrollment, patients must have had bilateral mammograms within 6 months.

• Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.

• Patients with a history of non-breast malignancies are eligible if they have been disease free for 5 or more years prior to enrollment and are deemed by their physicians to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

Exclusion Criteria:

• Age < 50 years

• Hormone unresponsive breast cancer

• T-2 ( > 3.0 cm), T-3, Stage III, or Stage IV breast cancer.

• N-1, N-2, or N-3 clinical axillary nodes

• Mastectomy intended

• Unwilling to undergo anti-endocrine therapy

• Suspicious microcalcification, densities, or palpable abnormalities ( in the ipsilateral or contralateral breast) unless biopsied and found to be benign.

• Non-epithelial breast malignancies such as sarcoma or lymphoma.

• Paget's disease of the nipple

• Proven multicentric carcinoma (invasive or DCIS) in more than one quadrant or separated by > 4 centimeters.

• Any prior treatment with radiation therapy, chemotherapy, biotherapy, or hormone therapy for the currently diagnosed breast cancer prior to study enrollment.

• Prior breast or thoracic RT for any condition.

• Psychiatric of addictive disorders or other condition that in the opinion of the investigator would preclude the patient from meeting the study requirements.

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal, Breast
• Estrogen Receptor-positive Breast Cancer
• Invasive Ductal Breast Carcinoma
• Invasive Ductal Breast Carcinoma With Predominant Intraductal Component
• Medullary Ductal Breast Carcinoma With Lymphocytic Infiltrate
• Mucinous Ductal Breast Carcinoma
• Papillary Ductal Breast Carcinoma
• Progesterone Receptor-positive Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Tubular Ductal Breast Carcinoma

Intervention

Radiation:
• accelerated partial breast irradiation
Undergo image-guided intensity-modulated APBI
• intensity-modulated radiation therapy
Undergo image-guided intensity-modulated APBI
• image-guided radiation therapy
Undergo image-guided intensity-modulated APBI

Procedure:
• therapeutic conventional surgery
Lumpectomy

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method	Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).	4-6 weeks post-APBI
Secondary	Acute surgical and radiotherapy toxicity as scored by the National Cancer Institute Common Toxicity Criteria (NCI CTCAE) version 4.0		Up to 4 weeks post-surgery
Secondary	Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0		Up to 5 years
Secondary	Cosmetic outcome by the physician and patient		At year 1
Secondary	Cosmetic outcome by the physician and patient		At year 3
Secondary	In-breast recurrence		Up to 5 years
Secondary	Regional recurrence		Up to 5 years
Secondary	Distant metastases		Up to 5 years
Secondary	Disease free survival		Up to 5 years
Secondary	Overall survival		Up to 5 years
Secondary	Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs	Correlative analyses	Up to 4 weeks post-surgery

External Links

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