Breast Cancer
Conditions
Keywords
Early Invasive N0, Non-Invasive
Brief summary
Standard therapy for patients with early stage breast cancer consists of surgery to remove the cancer followed by radiation therapy. One question regarding radiation therapy for early stage breast cancer is whether the entire breast needs to be radiated or only a more limited area surrounding the tumor. Whole-breast irradiation (WBI) is radiation therapy given to the whole breast. Partial-breast irradiation (PBI) is radiation therapy given only to the area of the breast where the cancer was removed (called the tumor bed). The investigators hope the option of PBI will reduce side effects from radiation therapy and shorten the radiation treatment process when compared to WBI, since only part of the breast is being treated. The investigators also hope that this will make such treatment more convenient for breast cancer patients. The purpose of the study is to evaluate the the safety of external-beam PBI in selected early breast cancer patients utilizing PBI in ten daily fractions over two weeks. The investigators will also evaluate the local control and the cosmetic results.
Detailed description
After signing the consent form, the following will be assessed. -CT scan of the breast that had the cancer removed to help plan the radiation therapy. This is referred to as a CT-simulation. This scan is done routinely as part of the regular treatment. PBI Study Treatment: You will be given PBI once daily over 10 treatment days (Mon-Fri) over a 2 week period. During this time you will have a weekly interview, physical examination, and your skin will be assessed for any side effects of the radiation. PBI will begin between 4 weeks to 3 months after breast surgery or 2-6 weeks after chemotherapy (if you have been given chemotherapy). After the final dose of the study: You will have the following scheduled follow-up visits: one at the completion of the radiation, once or twice during weeks 3-9 after the completion of radiation, once every 6 months for five years, and then once every year for the following five years after the completion of radiation therapy.
Interventions
RADIATIONExternal Beam Partial-Breast Irradiation
40 Gy in ten daily fractions over two weeks
Sponsors
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Unicentric Stage I invasive ductal breast cancer or Grade I or II DCIS measuring less than or equal to 2cm on pathology and/or mammography * Histologically negative tumor margin 2 mm or more from any inked edges, or no tumor in a re-excision specimen or final shaved specimen * Clips must be placed in the lumpectomy cavity at the time of final excision in order to aid in the delineation of the tumor cavity at the time of simulation and radiation delivery
Exclusion criteria
* No distant metastasis * Not pregnant or breastfeeding * No diffuse suspicious microcalcifications * No prior radiation therapy to the ipsilateral or contralateral breast or thorax * No histologic evidence of lymphovascular invasion (LVI) * No histologic evidence of EIC * No history of cosmetic or reconstructive breast surgery * No psychiatric illness that would prevent the patient from giving informed consent * No medical conditions that, in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient * No other currently active second malignancy other than non-melanoma skin cancers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | 2 years | The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if \>10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI. 1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. 2. The development of clinical fat necrosis. 3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically. The data is shown as the number of participants that experienced each of the specific toxicities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local Control Rates | 2 years | The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'. |
| Distant Control Rates | 2 years | The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain. |
| Breast Cosmesis | End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years | Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria. * Excellent: Little or no observable change * Good: Minimal but identifiable changes * Fair: Significant results of radiotherapy noted * Poor: Severe normal tissue sequelae |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Partial Breast Irradiation Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks
External Beam Partial-Breast Irradiation: 40 Gy in ten daily fractions over two weeks | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Partial Breast Irradiation |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants |
| Age, Continuous | 62 years |
| Estrogen Receptor Negative | 0 Participants |
| Estrogen Receptor Positive | 53 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Her2 FISH Negative | 40 Participants |
| Her2 FISH Not Done | 12 Participants |
| Her2 FISH Positive | 1 Participants |
| Her2 IHC (0, 1+) Her2 Negative | 34 Participants |
| Her2 IHC (2+) / Borderline | 4 Participants |
| Her2 IHC (3+) / Her2 Positive | 1 Participants |
| Her2 IHC Not Done | 14 Participants |
| Histologic Grade Moderately Differentiated | 26 Participants |
| Histologic Grade Other | 5 Participants |
| Histologic Grade Poorly Differentiated | 1 Participants |
| Histologic Grade Well Differentiated | 21 Participants |
| Method of Initial Diagnosis Mammogram | 51 Participants |
| Method of Initial Diagnosis MRI ( magnetic resonance imaging) | 1 Participants |
| Method of Initial Diagnosis Other | 1 Participants |
| Progesterone Receptor Few/ Faint Cells | 3 Participants |
| Progesterone Receptor Negative | 3 Participants |
| Progesterone Receptor Positive | 47 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 2 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 54 Participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 0 Participants |
| Side of the breast cancer Left Breast | 27 Participants |
| Side of the breast cancer Right Breast | 26 Participants |
| Stage Stage 0 | 8 Participants |
| Stage Stage 1 | 45 Participants |
| T staging T1a | 17 Participants |
| T staging T1b | 22 Participants |
| T staging T1c | 6 Participants |
| T staging Tis | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 53 |
| other Total, other adverse events | 47 / 53 |
| serious Total, serious adverse events | 2 / 53 |
Outcome results
Primary
Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks
The safety of external-beam PBI in selected stages 0 and I female breast cancer patients utilizing 40 Gy in ten daily fractions over two weeks. The study will be deemed too toxic if \>10% of enrolled patients have at least one of the following outcomes within 24 months of completion of PBI. 1. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. 2. The development of clinical fat necrosis. 3. The development of rib fracture on the ipsilateral treated side, detected either clinically and/or radiographically. The data is shown as the number of participants that experienced each of the specific toxicities.
Time frame: 2 years
Population: Analysis does not include the one participant who withdrew consent before outcome was met.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Partial Breast Irradiation | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | Grade 3 or 4 Skin/ Subcutaneous toxicity | 0 Participants |
| Partial Breast Irradiation | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | Grade 3 or 4 Pulmonary Toxicity | 0 Participants |
| Partial Breast Irradiation | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | Fat Necrosis | 0 Participants |
| Partial Breast Irradiation | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks | Rib fractures on ipsilateral treated side | 0 Participants |
Secondary
Breast Cosmesis
Breast Cosmesis was assessed using a cosmetic scoring system. The data shown represent the latest assessment for each participant at the time of analysis. Cosmetic changes were assessed using the following the following criteria. * Excellent: Little or no observable change * Good: Minimal but identifiable changes * Fair: Significant results of radiotherapy noted * Poor: Severe normal tissue sequelae
Time frame: End of treatment, 4-9 weeks post treatment, every six months for first 5 years, then annually for 5 years
Population: The one participant that withdrew consent before outcomes were met was excluded from the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Partial Breast Irradiation | Breast Cosmesis | Excellent | 39 Participants |
| Partial Breast Irradiation | Breast Cosmesis | Good | 12 Participants |
| Partial Breast Irradiation | Breast Cosmesis | Fair | 2 Participants |
| Partial Breast Irradiation | Breast Cosmesis | Poor | 0 Participants |
Secondary
Distant Control Rates
The number of participants that achieved distant control. Distant control is defined as a lack of distant metastasis following the completion of treatment. Distant metastasis refers to the development of disease at distant body sites like the lung, liver, bone, or brain.
Time frame: 2 years
Population: The one participant that withdrew consent before the outcome was met was excluded from the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Partial Breast Irradiation | Distant Control Rates | Distant Metastasis | 0 Participants |
| Partial Breast Irradiation | Distant Control Rates | Distant Control | 53 Participants |
Secondary
Local Control Rates
The local control rates (analyzed separately for patients with DCIS and invasive cancer). Local control is defined as lack of recurrence in the treated breast and ipsilateral axillary, supraclavicular and internal mammary lymph nodes. Recurrence is defined as the regrowth of tumor cells left following initial therapy and/or the development of new primary tumors unrelated to the original one. DCIS stands for 'Ductal Carcinoma In Situ'.
Time frame: 2 years
Population: The one participant that withdrew consent before the outcome was met was excluded from the analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Partial Breast Irradiation | Local Control Rates | Local Control | 8 Participants |
| Partial Breast Irradiation | Local Control Rates | Local Recurrence | 0 Participants |
| Partial Breast Irradiation - Invasive Cancer | Local Control Rates | Local Control | 45 Participants |
| Partial Breast Irradiation - Invasive Cancer | Local Control Rates | Local Recurrence | 0 Participants |