Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage I Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage II Breast Cancer
Conditions
Brief summary
This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed description
Adjuvant radiation therapy (RT) plays an important role in successful breast conservation in early-stage breast cancer and has been shown to significantly reduce the risk of breast cancer recurrence over surgery alone. Adding breast radiation to lumpectomy has allowed women to keep their natural breast, as multiple randomized trials have demonstrated equivalent overall and disease-free survival compared to a mastectomy. Meta-analyses have concluded that post-lumpectomy radiation improves breast cancer survival, with an estimated 1 life saved for every 4 recurrences prevented. An important component of radiation therapy is the time-dose-fractionation schedule. Up until the last decade, the standard radiation schedule in North America involved 6-8 weeks of daily radiation. This study proposes that fractionation will provide a significant improvement in convenience and cost effectiveness, while delivering equivalent cancer control. This will be a phase II single arm non-inferiority trial. Trial patients will receive 9 fractions hypofractionated radiation. Patients will be evaluated for breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.
Interventions
RADIATIONHypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast * Final pathologic Tis, T1-T3, all must be N0 and M0 status. * Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia * Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields * Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation. * Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =\< 7 days prior to registration * A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months * Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy * Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1 * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion criteria
* Prior radiation therapy to the chest, neck or axilla * Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed * History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed * Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis * Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable * Co-existing medical conditions with life expectancy \< 5 years * Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix * Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation * Neuroendocrine carcinoma or sarcoma histology * Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | Up to 24 months post radiation therapy (RT) | The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | 6 months post RT | * Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
| Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | 24 months post RT | * Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome. |
| Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity | Up to 5 years | The proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect. |
| Local and Local Regional Recurrence Rate | Up to 60 months | We will report the incidence of recurrence |
| Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation | Up to 3 years | Will be explored using cost data and quality adjusted life years (QALYs) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Within 12 weeks after breast conserving surgery, participants undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Hypofractionated Radiation Therapy: Undergo hypofractionated radiation therapy | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 32 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 58.71 years STANDARD_DEVIATION 10.72 |
| Breast photographic cosmetic scores Excellent | 36 Participants |
| Breast photographic cosmetic scores Fair | 19 Participants |
| Breast photographic cosmetic scores Good | 32 Participants |
| Breast photographic cosmetic scores Poor | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 102 |
| other Total, other adverse events | 102 / 102 |
| serious Total, serious adverse events | 4 / 102 |
Outcome results
Primary
Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy
The EORTC (European Organisation for Research and Treatment of Cancer) Breast Cosmetic Rating system is a blinded digital photographic method that compares the radiated breast with the contralateral untreated side and evaluates: Size, shape, location of the areola/nipple, appearance of the surgical scar, skin pigmentation changes, presence of telangiectasia and a global cosmetic score based on all of the factors. Characteristics are graded on a four-point scale: 0, excellent or no difference; 1, good or small difference; 2, fair or moderate difference; and 3, poor or large difference. Images taken at the 24 month timepoint were assessed by 3 unbiased reviewers including a radiation oncologist, surgeon and nurse. The data is presented as the count of participants meeting the overall rating criteria as assessed by these reviewers.
Time frame: Up to 24 months post radiation therapy (RT)
Population: Of 102 total enrolled participants, images from 78 participants at this timepoint were available and of sufficient quality to be reviewed and scored by the 3 unbiased reviewers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment | Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | Excellent | 17 Participants |
| Treatment | Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | Good | 26 Participants |
| Treatment | Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | Fair | 24 Participants |
| Treatment | Percentages of Participants by EORTC Breast Cosmetic Rating Score at 24 Months Post-radiation Therapy | Poor | 11 Participants |
Secondary
Cost-effectiveness (CE) of Hypofractionated Radiation Versus Standard Fractionation
Will be explored using cost data and quality adjusted life years (QALYs)
Time frame: Up to 3 years
Secondary
Incidence of Acute and Late Radiation Complications Based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 Toxicity
The proportion of patients with acute or late radiation complications, will be estimated. Any event longer than 3 months will be considered a late effect.
Time frame: Up to 5 years
Secondary
Local and Local Regional Recurrence Rate
We will report the incidence of recurrence
Time frame: Up to 60 months
Secondary
Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint
* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Time frame: 24 months post RT
Population: -80 sexual well-being subscale questionnaires were completed at this timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | Physical well-being | 77.9 score on a scale | Standard Deviation 23.1 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | Psychosocial well-being | 79.6 score on a scale | Standard Deviation 22.4 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | Sexual well-being | 63 score on a scale | Standard Deviation 28.2 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 24 Month Post-RT Timepoint | Satisfaction with breasts | 68.8 score on a scale | Standard Deviation 21.6 |
Secondary
Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint
* Assessed 4 subscales: satisfaction with breasts, psychosocial well-being, physical well-being, and sexual well-being. * Score from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Time frame: 6 months post RT
Population: * 80 sexual well-being subscale questionnaires were completed at this timepoint~* 95 satisfaction with breasts subscale questionnaires were completed at this timepoint
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | Physical well-being | 68.2 score on a scale | Standard Deviation 22.9 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | Psychosocial well-being | 79.6 score on a scale | Standard Deviation 20.2 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | Sexual well-being | 63.4 score on a scale | Standard Deviation 26.1 |
| Treatment | Quality of Life as Measured by Breast-Q Questionnaire Scores at 6 Month Post-RT Timepoint | Satisfaction with breasts | 69 score on a scale | Standard Deviation 20.7 |