Proton Accelerated Partial Breast Irradiation

Phase 2

Withdrawn

• Conditions: Breast Cancer
• Interventions: Radiation: Proton Accelerated Partial Breast Irradiation

• Registration Number: NCT03940248
• Lead Sponsor: University of Cincinnati

Brief Summary

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Study Start: 2020-07-01
• Primary Completion: 2021-07-08
• Study Completion: 2021-07-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-28
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
• Patients must be ≥ 50 years old.
• Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
• Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
• Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
• On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.
• Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
• Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
• The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
• Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
• Proton APBI should start within 12 weeks from the time of surgery.

Exclusion Criteria

• Male
• Patients < 50 years of age.
• Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
• If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
• Patients with persistently positive margins despite attempted re-excision.
• Proven multicentric disease or extensive LVSI.
• Clear delineation of the extent of the target partial mastectomy cavity is not possible.
• Patients who have undergone oncoplastic reconstruction.
• Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
• Any patients who require adjuvant chemotherapy following lumpectomy.
• Patients whose primary tumor is ER negative.
• Patients with high grade ductal carcinoma in situ.
• Patients with known BRCA1 or BRCA2 mutation.
• Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
• Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
• Pregnancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Stage Breast Cancer	Proton Accelerated Partial Breast Irradiation	Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

Primary Outcome Measures

Name	Time	Method
Cosmetic outcome (change in appearance as compared to untreated breast)	Through Study Completion, an average of 2 years	Physician and Nurse Harvard Cosmesis Scale \[1 (excellent) through 4 (poor)\]

Secondary Outcome Measures

Name	Time	Method
Rates of acute (within 3 months of treatment) toxicity	Through Study Completion, an average of 2 years	Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Rates of late (> 3 months after treatment) toxicity	Through Study Completion, an average of 2 years	Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease.	Through Study Completion, an average of 2 years	Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy
Rate of regional recurrence	Through Study Completion, an average of 2 years	Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.

Trial Locations

Locations (1)

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States