Breast Cancer
Conditions
Brief summary
The goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins. An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.
Detailed description
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for Radiation Therapy (RT) naïve patients at New York Presbyterian using EBRT or with the fractionation of 4050 cGy in 15 fractions over 3 weeks, based on the previous treatment that they received. The main aim of the study is to evaluate the rate of early grade 3 toxicities with this approach.
Interventions
RADIATION600cGY x 5 fractions APBI
Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT
RADIATION270cGy x 15 fractions WBRT
Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Isolated ipsilateral unifocal breast lesions * Limited size (\< 2-3 cm) without evidence of skin involvement * Histologically proven invasive breast carcinoma or carcinoma in situ * Negative histologic margins of resection * Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension * No synchronous distant metastases * Age ≥ 18 years * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence * Previous WBI or IORT, brachytherapy or external beam partial breast treatment * Technical feasibility * Every kind of systemic therapy is allowed * Informed consent for clinical and research purposes signed
Exclusion criteria
* Regional recurrences (axillary, supraclavicular) * Positive histologic margins at resection * Metastatic disease * Poor cosmesis from previous surgery and RT * Extensive Intraductal Component
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of treatment related adverse events as graded by CTCAE version 5.0 | up to 1 year from completion of radiation treatment | The primary endpoint of the study is to test the feasibility in terms of acute toxicity of a protocol of partial breast re-irradiation for breast cancer treatment in a previously irradiated whole breast, as defined by the rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain AEs, as graded by CTCAE version 5.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with late toxicity will be measured as graded by CTCAE version 5.0 | up to 60 months | Late toxicity is defined as the adverse events experienced by patients after 90 days post radiation therapy. |
| Change in number of participants with skin changes | baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months. | This count of participants will include patients who experience the following: skin hyperpigmentation, fibrosis, telangiectasia, skin induration and edema. |
| Change in Quality of life as assessed by Breast Cancer treatment outcome scale (BCTOS) | baseline, approx. week 1- week 2 of radiation, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months. | The Breast Cancer Treatment Outcomes Scale (BCTOS) will be used to evaluate patient-reported cosmetic outcome, functional status, and breast pain. Each BCTOS subscale (cosmetic, functional status, and breast pain) is calculated by computing the arithmetic mean of the answers to each item relevant to a given subscale. The score is a continuous variable ranging from 1 to 4, with 1 indicating no difference between the treated and untreated breast, 2 indicating a slight difference, 3 indicating a moderate difference, and 4 indicating a large difference. Participants completing the BCTOS is optional. |
| Number of participants who demonstrate local control | 60 months | Patients will be followed for recurrence of cancer in the treated breast. |
| Disease free survival (DFS) will be measured | 60 months | — |
| Overall Survival (OS) will be measured. | 60 months | — |
| Number of participants who received subsequent mastectomy in the treated breast | 6 months | The investigators will track for enrolled patients the rate of subsequent mastectomy in the treated breast |
Countries
United States
Contacts
CONTACTFabiana Gregucci
PRINCIPAL_INVESTIGATORJohn Ng, M.D.
Weill Medical College of Cornell University
Outcome results
None listed