Phyllodes Tumor
Conditions
Keywords
Phyllodes
Brief summary
In 2008 a research study conducted by Dr. Barth involving 46 women determined that whole breast radiation therapy performed after a lumpectomy of borderline and malignant phyllodes tumors decreases rate of recurrence. None of the 46 participants developed a local recurrence. Based on information we have learned from research studies, we recommend whole breast radiation therapy for women with malignant and borderline phyllodes tumors after they receive a lumpectomy. New methods for delivering breast radiotherapy are being developed that allow radiation to be delivered solely to the site of the surgical resection. This is called partial breast radiation. The main advantage of partial breast radiation is that it simplifies treatment for the patient. Radiation is delivered twice a day for 5 days, rather than 5 days per week for 6 weeks. The main concern is that partial breast radiation might miss other sites of breast cancer in the breast receiving the radiation. Evidence is accumulating from research studies that partial breast radiation therapy after surgical removal of the more common type of breast cancer, invasive ductal carcinoma, the breast results in rates of local recurrence that are comparable to those seen after whole breast radiation therapy. In contrast to patients with invasive ductal cancers of the breast, it is very rare for patients to have phyllodes tumors that appear in more than one area of the breast. Review of research data determined that cancer recurrences seen in patients with phyllodes tumors that had undergone lumpectomies were almost always at the original tumor site. Therefore, partial breast radiation is likely to be as effective as whole breast radiation therapy after resection of malignant phyllodes tumors. The purpose of the study is to determine what the chances are that a phyllodes tumor will recur in the breast when the breast is treated with partial breast radiation therapy after a lumpectomy.
Interventions
RADIATIONPartial breast radiation after lumpectomy
Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.
Sponsors
Dartmouth-Hitchcock Medical Center
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
* Histologic proof of phyllodes tumor of borderline or malignant grade, as first defined by Pietruszka and modified by Azzopardi and adopted by the World Health Organization (1,2,17): * Borderline malignant: 5-9 mitoses/10 HPF, pushing or infiltrating margins, 2+ (moderate) stromal cellularity and atypia. * Malignant: 10 or more mitoses / 10 HPF, predominantly infiltrating margins, usually 3+ (severe) stromal cellularity and atypia but occasionally 2+. * The tumor has been excised with a breast-conserving resection and there is no tumor seen at any of the margins of the resection. * No prior breast carcinoma or ductal carcinoma in situ in the ipsilateral breast. Patients with a local recurrence of a previously excised phyllodes tumor are eligible if the recurrence is in the area of the previous excision. * No history of irradiation of the ipsilateral breast. * No evidence of other areas worrisome for cancer on physical examination and mammography of the ipsilateral breast. * Age \>18 years. * Informed consent. * Documentation that either: 1. the patient's medical insurance company has certified that they will pay for the cost of radiation therapy treatments, or 2. a letter from the patient indicating that they explicitly understand the costs of radiation therapy and that the sponsor (Principal Investigator) of this study will not be held responsible for these costs.
Exclusion criteria
* Histologically positive margins. * Breast carcinoma or ductal carcinoma in situ in the ipsilateral breast. * A history of irradiation to the ipsilateral breast. * Pregnancy. A urine pregnancy test will be performed on each fertile premenopausal female prior to entry into the study. Patients with childbearing potential must employ effective contraception during the radiation therapy. * A radiation planning CT scan which demonstrates a target lumpectomy cavity that is not clearly delineated or a target lumpectomy cavity/whole breast reference volume \> 30%. * Unacceptable radiation therapy quality assurance parameters, as defined in Section 5 of the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants With Local Recurrence up to 10 Years | up to 10 years | The primary objective is to determine the local recurrence rate for patients with borderline or malignant phyllodes tumors treated with breast conserving resection with negative margins and adjuvant partial breast radiation therapy. Recurrence rate is measured by occurrence of biopsy proven recurrences during follow up, up to 10 years following patient enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls | up to 10 years | The secondary objective is to compare the local recurrence rate observed after partial breast radiation therapy with that observed in historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. This is measured by occurrence of biopsy proven recurrence up to 10 years after participant enrollment. |
Countries
United States
Participant flow
Recruitment details
Historical controls were not enrolled as part of this study. Information regarding the historical controls can be found under NCT00003404.
Participants by arm
| Arm | Count |
|---|---|
| Partial Breast Radiation After Lumpectomy Radiation per NSABP B-39/R0413 protocol.
Partial breast radiation after lumpectomy: Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol. | 11 |
| Historical Control Historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins | 46 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Study closed early - low accrual | 6 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Partial Breast Radiation After Lumpectomy | Total | Historical Control |
|---|---|---|---|
| Age, Continuous | 46 years | 47.5 years | 49 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 9 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 47 Participants | 46 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 47 Participants | 46 Participants |
| Race (NIH/OMB) White | 10 Participants | 10 Participants | 0 Participants |
| Region of Enrollment United States | 11 participants | 57 participants | 46 participants |
| Sex: Female, Male Female | 11 Participants | 57 Participants | 46 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 1 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Rate of Participants With Local Recurrence up to 10 Years
The primary objective is to determine the local recurrence rate for patients with borderline or malignant phyllodes tumors treated with breast conserving resection with negative margins and adjuvant partial breast radiation therapy. Recurrence rate is measured by occurrence of biopsy proven recurrences during follow up, up to 10 years following patient enrollment.
Time frame: up to 10 years
Population: The following participants did not complete 10 years of follow up and were followed until the time points listed below:~1. participant lost to follow up after 6 months~2. participants lost to follow up after 1 year~1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure: 2 participants 4.5 years~1 participant 5 years~1 participant 6 years~1 participant 8 years~1 participant 9 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Partial Breast Radiation After Lumpectomy | Rate of Participants With Local Recurrence up to 10 Years | 0 Participants |
Secondary
Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls
The secondary objective is to compare the local recurrence rate observed after partial breast radiation therapy with that observed in historical controls treated with whole breast radiation therapy after breast conserving resection with negative margins. This is measured by occurrence of biopsy proven recurrence up to 10 years after participant enrollment.
Time frame: up to 10 years
Population: The following participants did not complete 10 years of follow up and were followed until the time points listed below:~1. participant lost to follow up after 6 months~2. participants lost to follow up after 1 year~1 participant withdrew after 9 years 6 participants remained on study until early study closure they were at the following time points at closure 2 participants 4.5 years~1 participant 5 years~1 participant 6 years~1 participant 8 years~1 participant 9 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Partial Breast Radiation After Lumpectomy | Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls | 0 Participants |
| Historical Controls | Rate of Participants With Local Recurrence After Radiation Compared to Historic Controls | 0 Participants |