External-Beam Partial-Breast Irradiation for Early Breast Cancer 40 Gy QD Over 2 Weeks
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Partial Breast Irradiation Partial Breast Irradiation using 40 Gy in 10 fractions over 2 weeks |
Radiation: External Beam Partial-Breast Irradiation
40 Gy in ten daily fractions over two weeks
|
Outcome Measures
Primary Outcome Measures
- 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. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. The development of clinical fat necrosis. 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Isreal Deaconness Medical Center | Boston | Massachusetts | United States | 02215 |
| 2 | Brigham and Women's Hosptial | Boston | Massachusetts | United States | 02215 |
| 3 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 4 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02215 |
Sponsors and Collaborators
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Brigham and Women's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11-351
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Partial Breast Irradiation |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 54 |
| COMPLETED | 52 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Partial Breast Irradiation |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 54 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
39
72.2%
|
| >=65 years |
15
27.8%
|
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
62
|
| Sex: Female, Male (Count of Participants) | |
| Female |
54
100%
|
| Male |
0
0%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
47
87%
|
| Not Hispanic or Latino |
1
1.9%
|
| Unknown or Not Reported |
6
11.1%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
1
1.9%
|
| White |
51
94.4%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
2
3.7%
|
| Region of Enrollment (Count of Participants) | |
| United States |
54
100%
|
| Method of Initial Diagnosis (Count of Participants) | |
| Mammogram |
51
94.4%
|
| MRI ( magnetic resonance imaging) |
1
1.9%
|
| Other |
1
1.9%
|
| Side of the breast cancer (Count of Participants) | |
| Left Breast |
27
50%
|
| Right Breast |
26
48.1%
|
| Stage (Count of Participants) | |
| Stage 0 |
8
14.8%
|
| Stage 1 |
45
83.3%
|
| T staging (Count of Participants) | |
| Tis |
8
14.8%
|
| T1a |
17
31.5%
|
| T1b |
22
40.7%
|
| T1c |
6
11.1%
|
| Her2 FISH (Count of Participants) | |
| Negative |
40
74.1%
|
| Positive |
1
1.9%
|
| Not Done |
12
22.2%
|
| Her2 IHC (Count of Participants) | |
| (3+) / Her2 Positive |
1
1.9%
|
| (2+) / Borderline |
4
7.4%
|
| (0, 1+) Her2 Negative |
34
63%
|
| Not Done |
14
25.9%
|
| Estrogen Receptor (Count of Participants) | |
| Positive |
53
98.1%
|
| Negative |
0
0%
|
| Progesterone Receptor (Count of Participants) | |
| Positive |
47
87%
|
| Few/ Faint Cells |
3
5.6%
|
| Negative |
3
5.6%
|
| Histologic Grade (Count of Participants) | |
| Well Differentiated |
21
38.9%
|
| Moderately Differentiated |
26
48.1%
|
| Poorly Differentiated |
1
1.9%
|
| Other |
5
9.3%
|
Outcome Measures
| Title | Safety of External-beam PBI Utilizing 40Gy in Ten Daily Fractions Over Two Weeks |
|---|---|
| Description | 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. Grade 3 or 4 skin/subcutaneous or pulmonary toxicity. The development of clinical fat necrosis. 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Analysis does not include the one participant who withdrew consent before outcome was met. |
| Arm/Group Title | Partial Breast Irradiation |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 53 |
| Grade 3 or 4 Skin/ Subcutaneous toxicity |
0
0%
|
| Grade 3 or 4 Pulmonary Toxicity |
0
0%
|
| Fat Necrosis |
0
0%
|
| Rib fractures on ipsilateral treated side |
0
0%
|
| Title | Local Control Rates |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The one participant that withdrew consent before the outcome was met was excluded from the analysis |
| Arm/Group Title | Partial Breast Irradiation - DCIS Only | Partial Breast Irradiation - Invasive Cancer |
|---|---|---|
| Arm/Group Description | 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 Participants with DCIS only | 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 Participants with Invasive breast cancer |
| Measure Participants | 8 | 45 |
| Local Control |
8
14.8%
|
45
NaN
|
| Local Recurrence |
0
0%
|
0
NaN
|
| Title | Distant Control Rates |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The one participant that withdrew consent before the outcome was met was excluded from the analysis |
| Arm/Group Title | Partial Breast Irradiation |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 53 |
| Distant Control |
53
98.1%
|
| Distant Metastasis |
0
0%
|
| Title | Breast Cosmesis |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The one participant that withdrew consent before outcomes were met was excluded from the analysis. |
| Arm/Group Title | Partial Breast Irradiation |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 53 |
| Excellent |
39
72.2%
|
| Good |
12
22.2%
|
| Fair |
2
3.7%
|
| Poor |
0
0%
|
Adverse Events
| Time Frame | Toxicity is assessed at the end of treatment (two weeks), once or twice at 3-9 weeks post treatment, then every six months for 5 years, then once every year for five fear (total of 10 years). Median duration of 28 months at the time of analysis. | |
|---|---|---|
| Adverse Event Reporting Description | The participant that withdrew consent was not able to be assessed for adverse events and was not included in the adverse event analysis. | |
| Arm/Group Title | Partial Breast Irradiation | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Partial Breast Irradiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/53 (0%) | |
Serious Adverse Events |
||
| Partial Breast Irradiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/53 (3.8%) | |
| Injury, poisoning and procedural complications | ||
| Seroma | 1/53 (1.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Skin Infection | 1/53 (1.9%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Partial Breast Irradiation | ||
| Affected / at Risk (%) | # Events | |
| Total | 47/53 (88.7%) | |
| Gastrointestinal disorders | ||
| Nausea | 1/53 (1.9%) | 1 |
| General disorders | ||
| Fatigue | 19/53 (35.8%) | 19 |
| Localized edema | 4/53 (7.5%) | 5 |
| Non-cardiac chest pain | 1/53 (1.9%) | 1 |
| Pain | 2/53 (3.8%) | 2 |
| Injury, poisoning and procedural complications | ||
| Dermatitis radiation | 34/53 (64.2%) | 41 |
| Musculoskeletal and connective tissue disorders | ||
| Fibrosis deep connective tissue | 8/53 (15.1%) | 9 |
| Reproductive system and breast disorders | ||
| Breast pain | 7/53 (13.2%) | 8 |
| Reproductive system and breast disorders - Other, specify | 1/53 (1.9%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough | 1/53 (1.9%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Erythema multiforme | 5/53 (9.4%) | 6 |
| Pruritus | 1/53 (1.9%) | 1 |
| Skin and subcutaneous tissue disorders - Other, specify | 2/53 (3.8%) | 2 |
| Skin hyperpigmentation | 27/53 (50.9%) | 31 |
| Skin induration | 6/53 (11.3%) | 6 |
| Vascular disorders | ||
| Hot flashes | 1/53 (1.9%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alphonse Taghian, MD, PhD |
|---|---|
| Organization | Massachusetts General Hospital |
| Phone | 617-726-7559 |
| ATAGHIAN@mgh.harvard.edu |
- 11-351