Invasive Breast Cancer
Conditions
Keywords
Breast Cancer, Mastectomy
Brief summary
In this study we are looking at a type of radiation called proton radiation which is known to spare surrounding tissue and organs from radiation. The proton radiation will be delivered using 3D conformal proton radiation or scanned beam/IMPT (Intensity Modulated Proton Radiation Treatment). Proton radiation delivers no dose beyond the region requiring treatment. This may reduce side effects that patients would normally experience with conventional radiation therapy or other means of delivering proton radiation therapy. In this study we are evaluating the effectiveness of using proton radiation delivered to reduce side effects association with radiation treatment.
Detailed description
Proton radiation will be delivered daily for approximately 5 1/2 weeks. Patients will be assessed weekly for any side effects they may be experiencing. Patients will have follow-up visits 4 weeks after proton therapy ends, at 6 months, 12 months, and then every year for up to five years after treatment. Follow-up visits will include a physical examination, radiological imaging (if necessary), echocardiogram, and laboratory tests.
Interventions
RADIATIONProton Radiation
45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
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 breast cancer confined to the breast and regional lymphatics * Completed mastectomy (complete not partial )breast surgery +/- reconstructive surgery * Life expectancy \> 12 months
Exclusion criteria
* Pregnant or breast-feeding * Prior therapeutic radiation \> 200 cGy * History of a different malignancy unless disease-free for at least 5 years or diagnosed and treated cervical cancer in situ, or basal or squamous cell cancer of the skin * Prior investigation chemotherapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event | From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks | To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or \> radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate and Severity of Radiation Pneumonitis | From the start of treatment until 3 months after the end of treatment and was not included in the analysis population. | The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe * Grade 4: Life-Threatening * Grade 5: Fatal |
| Summary of Late Skin Toxicity | From 3 months after the end of treatment up to 5 years | A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). |
| To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome | From the start of treatment until 5 years post treatment | — |
| The Number of Participants With Acute Skin Toxicities | From the start of treatment until 3 months after the end of treatment | Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). |
| The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction | From the start of treatment until 5 years post treatment | — |
| The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy | Baseline and then 4 and 8 weeks post treatment | The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects. |
| Progression Free Survival | from the start of treatment until the time of disease progression, up to 5 years | Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions. |
| Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation | From the start of treatment until 5 years post treatment | Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Proton Radiation Radiation therapy with proton beam
Proton Radiation: 45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Proton Radiation |
|---|---|
| Age, Continuous | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 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 | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 63 Participants |
| Region of Enrollment United States | 70 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 70 / 70 |
| serious Total, serious adverse events | 20 / 70 |
Outcome results
Primary
Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event
To determine the feasibility of using proton radiation for the treatment of invasive breast cancer following mastectomy based on the occurrence of grade 3 or \> radiation pneumonitis or any grade 4 adverse event within 3 months after the completion of radiation treatment.
Time frame: From the start of treatment until 3 months after the end of treatment, median duration of treatment of 6 weeks
Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Radiation | Number of Participants With Grade 3 or Higher Radiation Pneumonitis or Any Grade 4 Adverse Event | 0 Participants |
Secondary
Acute and Late Toxicity of Breast Reconstruction Following Proton Radiation
Combined summary of the acute (within 3 months of completing treatment) and late (3 months to 5 years after completion of treatment) toxicities experienced by participants thought to be related to breast reconstruction surgery following proton radiation treatment. Toxicities are assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time frame: From the start of treatment until 5 years post treatment
Secondary
Progression Free Survival
Progression-free survival is defined as the duration from the start of radiation to the date of objective disease progression or death due to any cause, whichever is earlier. Disease progression is defined as the appearance of one or more new lesions.
Time frame: from the start of treatment until the time of disease progression, up to 5 years
Secondary
Rate and Severity of Radiation Pneumonitis
The number of participants that experienced radiation pneumonitis within three months of the end of treatment. The participants that experienced radiation pneumonitis are grouped by grade. Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). * Grade 1: Mild * Grade 2: Moderate * Grade 3: Severe * Grade 4: Life-Threatening * Grade 5: Fatal
Time frame: From the start of treatment until 3 months after the end of treatment and was not included in the analysis population.
Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Proton Radiation | Rate and Severity of Radiation Pneumonitis | Grade 1 | 0 Participants |
| Proton Radiation | Rate and Severity of Radiation Pneumonitis | Grade 2 | 0 Participants |
| Proton Radiation | Rate and Severity of Radiation Pneumonitis | Grade 3 | 0 Participants |
| Proton Radiation | Rate and Severity of Radiation Pneumonitis | Grade 4 | 0 Participants |
| Proton Radiation | Rate and Severity of Radiation Pneumonitis | Grade 5 | 0 Participants |
Secondary
Summary of Late Skin Toxicity
A summary of the late skin toxicities experienced by participants. The number of participants effected is shown for each toxicity experienced. Skin toxicities were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time frame: From 3 months after the end of treatment up to 5 years
Secondary
The Number of Participants That Needed Unplanned Additional Surgery for Breast Reconstruction
Time frame: From the start of treatment until 5 years post treatment
Secondary
The Number of Participants With Acute Skin Toxicities
Summary of the number of participants with any grade acute skin toxicities. Acute skin toxicity was assessed from the start of treatment until 90 days after the end of treatment. Skin toxicity was assessed using Common Terminology Criteria for Adverse Events (CTCAE 4).
Time frame: From the start of treatment until 3 months after the end of treatment
Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Radiation | The Number of Participants With Acute Skin Toxicities | 69 Participants |
Secondary
The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy
The number of participant that had early signs of cardiac effects from radiation therapy as assessed using a Strain Echo-cardiogram. The data from the Echo-cardiogram was evaluated for signs of negative impacts to cardiac function as determined by the treating physician. Parameters considered in the evaluation of the echo-cardiogram by the physician included myocardial velocity, strain, strain rate, and torsion. Blood-based cardiac bio-markers pro-BNP and ultra-sensitive troponin-I were also assessed. Either a clinically meaningful change in the strain echo-cardiogram parameters or clinically meaningful elevation of the bio-markers was sufficient to be considered to have early signs of cardiac effects.
Time frame: Baseline and then 4 and 8 weeks post treatment
Population: One participant withdrew from the trial before the start of treatment and was not included in the analysis population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Proton Radiation | The Number of Participants With Early Signs of Cardiac Effects From Radiation Therapy | 0 Participants |
Secondary
To Evaluate Cosmetic Outcome and Patient Satisfaction With Cosmetic Outcome
Time frame: From the start of treatment until 5 years post treatment