Breast CarcinomaNCT01400399
Cosmetic Evaluation of Lumpectomy Versus Oncolytic Mammoplasty With Bilateral Breast Reduction for Early Stage Breast Cancer
An observational study of Breast Carcinoma, run by Coastal Carolina Radiation Oncology at 3 sites in United States.
Trial summary
This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy (BRM) followed by hypofractionated whole breast irradiation. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- How many people
- 84 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2010to Aug 2020
- Phase
- Observational
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who have had a lumpectomy or bilateral reduction mammoplasty followed by hypofractionated irradiation.
Who may be able to join
- Ductal carcinoma in situ (DCIS) or invasive ductal, medullary, papillary, colloid (mucinous) lobular or tubular histologies.
- American Joint Committee on Cancer (AJCC) DCIS or Stage T1- T2, N0 histologically confirmed invasive carcinoma of the breast treated with partial mastectomy with axillary evaluation as appropriate, axillary node dissection or sentinel node biopsy (SLN). Patients with DCIS with or without SLN or axillary node dissection are eligible. Patients greater than 70 years old, with stage 1 disease who are estrogen/progesterone receptor positive (ER/PR+), with or without SLN or axillary node dissection are also eligible.
- Partial mastectomy with or without reconstruction consisting of local tissue rearrangement and/or reduction mammoplasty (ipsilateral and bilateral). Patients who have undergone surgery and/or chemotherapy prior to treatment with radiation therapy are still eligible for enrollment and all evaluations and photographs will begin prior to radiation. Retrospective Placement of at least 3 surgical clips in the lumpectomy cavity is strongly encouraged. Retrospective data may be collected on women who have completed their entire course of treatment as long as they are formally consented.
- Unifocal breast cancer which may be encompassed by excision of a single portion of breast tissue.
- Negative inked histologic margins of partial mastectomy or re-excision specimen to be confirmed prior to radiation. Positive margins are unacceptable. Every effort should be made by the surgeon to obtain negative margins with the initial excision.
- Negative post-partial mastectomy mammography (if malignancy associated micro-calcifications were initially present.)
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- Tamoxifen or Arimidex therapy is allowed. If chemotherapy is administered prior to radiation (but following surgery), then a minimum of two weeks must elapse prior to the start of radiation therapy.
- The patient must be 50 years of age or older.
- Signed study-specific informed consent form prior to study entry.
Who cannot join
- Patients enrolled on another clinical trial involving any treatment which may affect the cosmesis of the bilateral breasts. This would include the taking of medications, vitamin supplements, variation in radiation or surgery or topical application to the breast.
- Patients who are node positive.
- Patients with distant metastases.
- Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Any previously treated contralateral breast carcinoma or synchronous ipsilateral breast carcinoma.
- Prior non-hormonal therapy or radiation therapy for the current breast cancer; prior chemotherapy if administered less than two weeks from the start of therapy.
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- Patients with Paget's disease of the nipple.
- Patients with prior breast reconstructive surgery including breast mastopexy or breast augmentation.
- Patients with skin involvement, regardless of tumor size.
- Patients with collagenous diseases, specifically systemic lupus erythematosis, scleroderma or dermatomyositis.
- Patients with severe peripheral vascular disease or coronary artery disease (ex. Previous acute myocardial infarction requiring stents or coronary artery bypass graft within past two years; prior bypass graft of any type etc.)
- Patients with co-existing medical conditions with life expectancy less than 5 years.
- Patients with psychiatric disorders that would preclude obtaining informed consent.
- Other malignancy except non-melanomatous skin cancer less than 5 years prior to participation in this study; the disease free interval from any prior carcinoma must be continuous.
- Patients who are pregnant or lactating.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Active, not recruiting
South Atlantic Radiation Oncology
Supply, North Carolina, 28462
- Recruiting
Coastal Carolina Radiation Oncology
Wilmington, North Carolina, 28401
- Recruiting
Zimmer Cancer Center
Wilmington, North Carolina, 28401
About this study
Official title: Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction
This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an established method of treatment for early breast cancer. Because breast conservation is essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor control are all important considerations during comprehensive treatment planning. Irradiation schemes have been demonstrated to be efficacious and with excellent short term cosmetic outcomes. However, their interaction with currently evolving surgical techniques needs to be examined in order to maintain optimal local control while preserving cosmetic outcome.
Read the detailed description
Breast cancer outcomes and cosmesis may differ by race. Limited but controversial data suggests that African-American women have worse cosmetic outcomes with hypofractionated irradiation than with conventional breast conservation. A growing body of data also suggests that African-American women have diminished oncologic outcomes when compared to Caucasian women in the United States. Further evaluation is needed to better understand the reason for these discrepancies.
- Conditions
- Breast Carcinoma
- Keywords
- AJCC DCIS or T1- T2, N0
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of cosmetic results as judged by the patient, surgeon and radiation oncologist at stated follow-up intervals that will judge cosmesis by serial photography and quality of life (QOL) forms.
Measured: 10 years
Secondary outcomes (2)
Ipsilateral breast recurrence rate. Disease status will be evaluated at routine patient follow-up appointments including routine mammography.
Measured: 10 years
Contralateral breast cancer rate. This will be monitored according to routine protocol including yearly mammograms and clinical breast exams.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2016 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coastal Carolina Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), New Hanover Regional Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael Nichols, MD, PhD, Principal investigator, Coastal Carolina Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400399
- Sponsor's protocol ID
- ZCC-2010
- Other IDs
- U54CA142152-02
- Status last verified
- Dec 2015
- First submitted
- 20 Jul 2011
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Evaluation of Hypofractionated Breast Irradiation in Patients Undergoing Standard Lumpectomy or Oncolytic Mammoplasty With Bilateral Breast Reduction
- ClinicalTrials.gov ID
- NCT01400399
- Acronym / sponsor ID
- ZCC-2010
- Conditions
- Breast Carcinoma
- Keywords
- AJCC DCIS or T1- T2, N0
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Coastal Carolina Radiation OncologyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), New Hanover Regional Medical Center
- Study start
- Aug 2010
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 22 Jul 2011 (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.
This study will evaluate the cosmetic outcome and examine factors contributing to cosmetic outcome in women treated with lumpectomy or bilateral breast reduction mammoplasty/mastopexy (BRM) followed by hypofractionated whole breast irradiation. Breast conservation is now an established method of treatment for early breast cancer. Because breast conservation is essentially a cosmetic alternative to mastectomy, quality of life, cosmetic outcome and tumor control are all important considerations during comprehensive treatment planning. Irradiation schemes have been demonstrated to be efficacious and with excellent short term cosmetic outcomes. However, their interaction with currently evolving surgical techniques needs to be examined in order to maintain optimal local control while preserving cosmetic outcome.
Detailed description
Breast cancer outcomes and cosmesis may differ by race. Limited but controversial data suggests that African-American women have worse cosmetic outcomes with hypofractionated irradiation than with conventional breast conservation. A growing body of data also suggests that African-American women have diminished oncologic outcomes when compared to Caucasian women in the United States. Further evaluation is needed to better understand the reason for these discrepancies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who have had a lumpectomy or bilateral reduction mammoplasty followed by hypofractionated irradiation.
Key inclusion criteria (9 listed)
- Ductal carcinoma in situ (DCIS) or invasive ductal, medullary, papillary, colloid (mucinous) lobular or tubular histologies.
- American Joint Committee on Cancer (AJCC) DCIS or Stage T1- T2, N0 histologically confirmed invasive carcinoma of the breast treated with partial mastectomy with axillary evaluation as appropriate, axillary node dissection or sentinel node biopsy (SLN). Patients with DCIS with or without SLN or axillary node dissection are eligible. Patients greater than 70 years old, with stage 1 disease who are estrogen/progesterone receptor positive (ER/PR+), with or without SLN or axillary node dissection are also eligible.
- Partial mastectomy with or without reconstruction consisting of local tissue rearrangement and/or reduction mammoplasty (ipsilateral and bilateral). Patients who have undergone surgery and/or chemotherapy prior to treatment with radiation therapy are still eligible for enrollment and all evaluations and photographs will begin prior to radiation. Retrospective Placement of at least 3 surgical clips in the lumpectomy cavity is strongly encouraged. Retrospective data may be collected on women who have completed their entire course of treatment as long as they are formally consented.
- Unifocal breast cancer which may be encompassed by excision of a single portion of breast tissue.
- Negative inked histologic margins of partial mastectomy or re-excision specimen to be confirmed prior to radiation. Positive margins are unacceptable. Every effort should be made by the surgeon to obtain negative margins with the initial excision.
Key exclusion criteria (15 listed)
- Patients enrolled on another clinical trial involving any treatment which may affect the cosmesis of the bilateral breasts. This would include the taking of medications, vitamin supplements, variation in radiation or surgery or topical application to the breast.
- Patients who are node positive.
- Patients with distant metastases.
- Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
- Any previously treated contralateral breast carcinoma or synchronous ipsilateral breast carcinoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of cosmetic results as judged by the patient, surgeon and radiation oncologist at stated follow-up intervals that will judge cosmesis by serial photography and quality of life (QOL) forms.
Time frame: 10 years
2 secondary outcomes
Ipsilateral breast recurrence rate. Disease status will be evaluated at routine patient follow-up appointments including routine mammography.
Time frame: 10 years
Contralateral breast cancer rate. This will be monitored according to routine protocol including yearly mammograms and clinical breast exams.
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2015.
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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.
Michael Nichols, MD, PhD principal investigator
Coastal Carolina Radiation Oncology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by Coastal Carolina Radiation Oncology 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 9 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: status not confirmed, as of the sponsor's last update on 9 Dec 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Belinda Lissor, AAS, CCRP (910-251-1839, blissor@ccradonc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of cosmetic results as judged by the patient, surgeon and radiation oncologist at stated follow-up intervals that will judge cosmesis by serial photography and quality of life (QOL) forms. (time frame: 10 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 9 Dec 2015.