A Feasibility And Phase Ii Trial Of Accelerated Partial Breast Irradiation Using Proton Therapy For Women With Stage IA-IIA Breast Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Stage IA-IIA Breast Cancer
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The overall objectives of the study are to establish feasibility and acute side effects of accelerated partial breast irradiation therapy, along with more long-term side effects and clinical efficacy of treatment.
Detailed Description
The purpose of the APBI Proton Therapy study is to examine the feasibility, side effects, and clinical efficacy of using proton therapy on only the tumor bed of women being treated for breast cancer after surgical removal of malignancy (as opposed to whole breast treatment). The study's aim is to establish the effects of this type of therapy as it compares to both traditional radiation and whole breast treatment therapies. In order to be eligible, the patient must be a female older than 50 with either invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies of stage IA-IIA breast cancer, ECOG performance status of 0-2, have margins of greater than or equal to 2mm, be node negative or have only microscopic node disease, have estrogen- or progesterone-positive breast cancer, and other eligibility criteria must be met that is more detailed to describe herein.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically confirmed diagnosis of invasive or non-invasive breast cancer.
- •Invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies.
- •AJCC T1 or T2; N0 or N1mic; Stage IA-IIA breast cancer or AJCC TIS (Stage 0) ductal carcinoma in situ without invasion
- •Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathological size is 3 cm or less).
- •Estrogen and/or progesterone receptor positive invasive breast cancer. DCIS stage 0 does not require receptor testing.
- •No evidence of distant metastatic disease as documented by history and physical examination (radiographic staging only to be performed as indicated by symptoms or physical findings.)
- •Patients must have an ECOG Performance Status of 0, 1 or 2
- •Patients must be able to provide informed consent.
- •Patients must have undergone breast-conserving surgery
- •All tumors (invasive and non-invasive disease) must be excised with a minimum margin width of ≥ 2 mm. Re-excision of surgical margins is permitted. Focally close (\<2 mm) or positive (tumor cells at the inked edge of the specimen) margins determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins or skin for anterior margins, are also acceptable.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Feasibility and the Acute Toxicity Profile of Accelerated Partial Breast Radiation Using Protons
Time Frame: 2 years
Number of Participants that meets the criteria of feasibility and acute toxicity will be reported. The objectives were both feasibility and acute toxicity profile of accelerated partial breast radiation using protons. Feasibility was based on multiple radiation planning and treatment parameters: (1) a patient cannot be given treatment because anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised; (2) a patient is unable to tolerate more than 20% of treatments using proton RT (ie, \>2 of the 10 fractions); and/or (3) a patient is unable to complete all treatment within 5 days of the estimated date of treatment completion or requires a treatment break of greater than 5 days. A feasibility rate \>90% was needed to proceed to the phase 2 portion. Outcomes measured and reported were: late toxicity was "% of participants with grade 3 or higher late toxicity"