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

Sponsor

Ohio State University Comprehensive Cancer Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02186470

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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	Radiation: accelerated partial breast irradiation Radiation: intensity-modulated radiation therapy Radiation: image-guided radiation therapy Procedure: therapeutic conventional surgery	N/A

Detailed 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:

To determine the acute and late surgical and radiation toxicity of preoperative APBI delivered with IMRT in the prone position.
To document the cosmetic appearance of the breast when treated with preoperative APBI IMRT in the prone position.
Establish the percentage of patients that can meet dosimetric goals and normal tissue constraints if treated with preoperative APBI IMRT in the prone position.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Oct 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (image-guided intensity-modulated APBI) 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.	Radiation: accelerated partial breast irradiation Undergo image-guided intensity-modulated APBI Other Names: APBI Radiation: intensity-modulated radiation therapy Undergo image-guided intensity-modulated APBI Other Names: IMRT Radiation: image-guided radiation therapy Undergo image-guided intensity-modulated APBI Procedure: therapeutic conventional surgery Lumpectomy

Arm

Intervention/Treatment

Experimental: Treatment (image-guided intensity-modulated APBI)

Radiation: accelerated partial breast irradiation

Undergo image-guided intensity-modulated APBI

Other Names:

APBI

Radiation: intensity-modulated radiation therapy

Undergo image-guided intensity-modulated APBI

Other Names:

IMRT

Radiation: image-guided radiation therapy

Undergo image-guided intensity-modulated APBI

Procedure: therapeutic conventional surgery

Lumpectomy

Outcome Measures

Primary Outcome Measures

The primary endpoint will be the reproducibility of the MRI directed preoperative APBI treatment method [4-6 weeks post-APBI]
Acceptability of the definition of treatment targets by MRI, radiation virtual IMRT plans and completion of treatment (APBI and surgery).

Secondary Outcome Measures

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]
Late surgical and radiotherapy toxicity as scored by the NCI CTCAE version 4.0 [Up to 5 years]
Cosmetic outcome by the physician and patient [At year 1]
Cosmetic outcome by the physician and patient [At year 3]
In-breast recurrence [Up to 5 years]
Regional recurrence [Up to 5 years]
Distant metastases [Up to 5 years]
Disease free survival [Up to 5 years]
Overall survival [Up to 5 years]
Exploratory evaluation of patient breast cancer tissue and serum for CSCs, biomarkers and miRNAs [Up to 4 weeks post-surgery]
Correlative analyses

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.