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

Not Applicable

Active, not recruiting

• Conditions: Estrogen Receptor-positive Breast Cancer; Medullary Ductal Breast Carcinoma with Lymphocytic Infiltrate; Tubular Ductal Breast Carcinoma; Invasive Ductal Breast Carcinoma; Invasive Ductal Breast Carcinoma with Predominant Intraductal Component; Mucinous Ductal Breast Carcinoma; Papillary Ductal Breast Carcinoma; Progesterone Receptor-positive Breast Cancer; Stage IA Breast Cancer; Stage IB Breast Cancer
• Interventions: Radiation: accelerated partial breast irradiation; Radiation: intensity-modulated radiation therapy; Radiation: image-guided radiation therapy; Procedure: therapeutic conventional surgery

• Registration Number: NCT02186470
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

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:

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.

Study Timeline

• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Study Start: 2016-04-29
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (image-guided intensity-modulated APBI)	therapeutic conventional surgery	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.
Treatment (image-guided intensity-modulated APBI)	accelerated partial breast irradiation	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.
Treatment (image-guided intensity-modulated APBI)	intensity-modulated radiation therapy	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.
Treatment (image-guided intensity-modulated APBI)	image-guided radiation therapy	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 3
Disease free 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
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
In-breast recurrence	Up to 5 years
Regional recurrence	Up to 5 years
Distant metastases	Up to 5 years
Overall survival	Up to 5 years

Trial Locations

Locations (1)

Ohio State University Comprehensive Cancer Center; 🇺🇸 Columbus, Ohio, United States