Breast CancerGCC 0919NCT01014715
Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer
A study testing Phase II - Preoperative Radiation followed by Lumpectomy. in people with Breast Cancer, run by University of Maryland, Baltimore at 3 sites in United States.
Trial summary
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI method used in this study is 3D (three dimensional) conformal external beam irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Phase II - Preoperative Radiation followed by Lumpectomy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2009to 12 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women who satisfy all of the following conditions are the only patients who will be eligible for this study:
- Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
- AJCC Stage I or IIA (T1N0 or T2N0) histologically confirmed invasive carcinoma of the breast with a primary lesion (less than/equal to 3 cm)by MRI or ultrasound
- Clinically negative axillary lymph nodes. Standard routine imaging assessment of the axilla is performed by either ultrasound or MRI. If lymph nodes are suspicious, a biopsy is required. An involved axilla is purposely excluded.
- Unifocal breast cancer (single focus which can be encompassed by one lumpectomy).
- Patients must have an estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth receptor 2 (H2N) analyses performed on the primary tumor prior to enrollment.
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- Based on pre-treatment planning CT scan, the ratio of the PTV to the reference breast volume should not exceed 25%.
- Patients must be greater than/equal to 18 years of age.
- Pretreatment evaluations required for eligibility include: bilateral mammogram, histologic confirmation of malignancy, and physical exam.
- Signed study-specific informed consent form prior to study entry.
- Women of childbearing potential must use an effective contraceptive method such as condom/diaphragm and spermicidal foam, intrauterine device (IUD), or prescription birth control pills.
Who cannot join
- Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:
- Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign.
- Patient with distant metastases.
- Patients with invasive lobular or extensive in-situ lobular carcinoma or pure ductal carcinoma in-situ or non-epithelial breast malignancies such as sarcoma or lymphoma.
- Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
- Patient whose tumor is not visible on radiation treatment planning CT scan
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- Palpable or radiographically suspicious ipsilateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Prior hormonal or non-hormonal therapy or radiation therapy for the current breast cancer.
- Patients with Paget's disease of the nipple.
- Patients with skin involvement, regardless of tumor size.
- Patients with a breast technically unsatisfactory for radiation therapy.
- Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
- Patients with co-existing medical conditions with life expectancy less than 2 years.
- Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
- Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ummc Msgcc
Baltimore, Maryland, 21201
Central Maryland Oncology Center
Columbia, Maryland, 21044
Baltimore Washington Medical Center
Glen Burnie, Maryland, 21061
About this study
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the PBI, the cancer will be surgically removed.
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy. The study will also learn about the feelings women have about how their breast looks after PBI and surgery.
Read the detailed description
This study will evaluate the feasibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. For selected patients with Stage I and II breast carcinoma, 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates. Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy. The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
- Conditions
- Breast Cancer
- Being tested
- Phase II - Preoperative Radiation followed by Lumpectomy.
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase II - Preoperative Radiation followed by Lumpectomy.Other
Sequential investigative question. All procedures are standard of care
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Phase II-Preoperative Radiation followed by Lumpectomy Receives: Other: Phase II - Preoperative Radiation followed by Lumpectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers.
This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume.
Measured: 5 years
Secondary outcomes (1)
Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate
These endpoints will be accomplished by utilizing the pathology report; the cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals; and the breast recurrence rate will be evaluated by disease status at routine patient follow-up appointments, including yearly mammography.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2014
- Study completion12 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Wendla Citron, MD, Principal investigator, UMMC MSGCC Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014715
- Sponsor's protocol ID
- HP-00042098
- Other IDs
- GCC 0919
- Acronym
- GCC 0919
- Status last verified
- Sep 2019
- First submitted
- 16 Nov 2009
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer
- ClinicalTrials.gov ID
- NCT01014715
- Acronym / sponsor ID
- GCC 0919 / HP-00042098
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- 12 Nov 2018 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the PBI, the cancer will be surgically removed.
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy. The study will also learn about the feelings women have about how their breast looks after PBI and surgery.
Detailed description
This study will evaluate the feasibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. For selected patients with Stage I and II breast carcinoma, 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates. Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy. The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: Phase II - Preoperative Radiation followed by Lumpectomy.Phase II-Preoperative Radiation followed by Lumpectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Women who satisfy all of the following conditions are the only patients who will be eligible for this study:
- Patient must have invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
- AJCC Stage I or IIA (T1N0 or T2N0) histologically confirmed invasive carcinoma of the breast with a primary lesion (less than/equal to 3 cm)by MRI or ultrasound
- Clinically negative axillary lymph nodes. Standard routine imaging assessment of the axilla is performed by either ultrasound or MRI. If lymph nodes are suspicious, a biopsy is required. An involved axilla is purposely excluded.
- Unifocal breast cancer (single focus which can be encompassed by one lumpectomy).
Key exclusion criteria (15 listed)
- Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:
- Evidence of suspicious microcalcifications which are separate from the known lesion unless pathologically confirmed to be benign.
- Patient with distant metastases.
- Patients with invasive lobular or extensive in-situ lobular carcinoma or pure ductal carcinoma in-situ or non-epithelial breast malignancies such as sarcoma or lymphoma.
- Patients with proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm) or with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phase II - Preoperative Radiation followed by Lumpectomy.Sequential investigative question. All procedures are standard of care | Other | Single Arm |
Primary outcome
The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers.
Time frame: 5 years
This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume.
1 secondary outcome
Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wendla Citron, MD principal investigator
UMMC MSGCC Department of Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase II - Preoperative Radiation followed by Lumpectomy. in people with Breast Cancer, run by University of Maryland, Baltimore at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.