Breast CancerNCT01278212
Accelerated Hypofractionated Radiotherapy (AHF-RT) for the Treatment of Breast Cancer
A study testing accelerated hypofractionated radiotherapy (AHF-RT) in people with Breast Cancer, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- accelerated hypofractionated radiotherapy (AHF-RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only women who satisfy all of the following conditions will be eligible for this study.
- must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
- must be at least 21 years old
- must have stage 0, I, or II breast cancer
- On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast.
- Surgical treatment of the breast must have been breast conserving surgery (BCS). The margins of the resected specimen must be histologically free of tumor (including DCIS component). Reexcision of surgical margins is permitted.
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- Gross disease may be unifocal or multifocal with pathologic (invasive and/or DCIS) tumor size excised with negative margins.
- Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
- must begin adjuvant therapy (chemotherapy or radiotherapy) within 9 weeks following the last surgery for breast cancer (lumpectomy, re-excision of margins, or axillary staging procedure)
- Patients must have all usual and customary hormone receptor (ER/PR) and estrogen receptor (ER) analysis performed on the primary tumor prior to enrollment. Patients with invasive disease must have HER2 receptor status determined (positive or negative) with immuno-histochemistry (IHC) and/or fluorescent in-situ hybridization (FISH).
- At the time of study enrollment, patients must have had a history \& physical exam within 4 months and a bilateral mammogram within 6 months.
- Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
- Patients must live in a county that is designated as Appalachian and/or rural by Kentucky Cancer Registry Criteria (see list below) and/or must hold their primary residence at least 10 miles from the nearest radiation facility. Patients who do not fit these criteria may still be considered eligible if they are determined to suffer significant financial and/or transportation hardship during a typical course of CF-RT or HF-RT (in the judgment of any of their treating physicians). Patients who live outside the Commonwealth of Kentucky are eligible if they fit any of these aforementioned conditions.
- Appalachian counties in KY include: Adair, Bath, Bell, Boyd, Breathitt, Carter, Casey, Clark, Clay, Clinton, Cumberland, Edmonson, Elliott, Estill, Fleming, Floyd, Garrard, Green, Greenup, Harlan, Hart, Jackson, Johnson, Knott, Knox, Laurel, Lawrence, Lee, Leslie, Letcher, Lewis, Lincoln, Madison, Magoffin, Martin, McCreary, Menifee, Metcalfe, Monroe, Montgomery, Morgan, Nicholas, Owsley, Perry, Pike, Powell, Pulaski, Robertson, Rockcastle, Rowan, Russell, Wayne, Whitley, Wolfe.
Who cannot join
- Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study.
- T3, stage III, or stage IV breast cancer
- More than 3 histologically positive axillary nodes
- Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
- One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.)
- Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor
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- Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters
- Paget's disease of the nipple
- Synchronous bilateral invasive or non-invasive breast cancer
- History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
- Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation (If surgical margins are rendered free of disease by reexcision, the patient is eligible.)
- Treatment plan that includes regional nodal irradiation
- Current therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention (Patients are eligible only if these medications are discontinued prior to enrollment.)
- Cosmetic breast implants (Patients who have had implants removed are eligible.)
- Prior breast or thoracic RT for any condition
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma
- Pregnancy or lactation at the time of proposed randomization. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
- Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
James Graham Brown Cancer Center
Louisville, Kentucky, 40202
About this study
Official title: A Phase II Study of Accelerated Hypofractionated Radiotherapy (AHF-RT) After Breast Conserving Surgery (BCS) in Medically Underserved Patients
The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer.
Read the detailed description
The traditional radiation treatment schedule for patients who have had a lumpectomy for early stage breast cancer is 15 to 30 treatments delivered once a day for 3 to 6 weeks. This treatment schedule can be inconvenient and costly for elderly, rural, uninsured, and minority patients. This study will evaluate a new radiation treatment schedule called whole-breast accelerated hypofractionated radiotherapy (AHF-RT). AHF-RT delivers higher doses of radiation in fewer treatments than traditional radiation therapy. The AHF-RT treatment course is completed with 5 radiation treatments delivered once a week for 5 weeks.
The purpose of this study is to determine if accelerated hypofractionated radiotherapy (AHF-RT) is a safe, effective, more convenient, and less costly alternative to traditional radiation that will offer the same chance of cure with no additional side effects.
- Conditions
- Breast Cancer
- Being tested
- accelerated hypofractionated radiotherapy (AHF-RT)
- Keywords
- breast cancer, breast neoplasm, breast tumor, radiotherapy, radiation, accelerated, lumpectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
accelerated hypofractionated radiotherapy (AHF-RT)Radiation
Also called accelerated hypofractionated radiation
30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
| Study group | Role | What they receive |
|---|---|---|
| AHF-RT | Experimental | accelerated hypofractionated radiotherapy (AHF-RT)
30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy Receives: Radiation: accelerated hypofractionated radiotherapy (AHF-RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumor Recurrence (IBTR)
Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.
Measured: at 5 years post completion of AHF-RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJan 2011
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Harriet Eldredge-Hindy, University of Louisville
- Investigators
- Harriet Eldredge-Hindy, MD, Principal investigator, James Graham Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278212
- Sponsor's protocol ID
- 10.0584
- Other IDs
- BCC-AHF-RT-10
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2011
- Last updated
- 22 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Accelerated Hypofractionated Radiotherapy (AHF-RT) After Breast Conserving Surgery (BCS) in Medically Underserved Patients
- ClinicalTrials.gov ID
- NCT01278212
- Acronym / sponsor ID
- 10.0584
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast neoplasm, breast tumor, radiotherapy, radiation, accelerated, lumpectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- James Graham Brown Cancer Center
- Study start
- Jan 2011
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 22 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to explore the safety, effectiveness, quality of life, and cost effectiveness of accelerated hypofractionated radiotherapy (AHF-RT) as treatment after lumpectomy in patients with early stage breast cancer.
Detailed description
The traditional radiation treatment schedule for patients who have had a lumpectomy for early stage breast cancer is 15 to 30 treatments delivered once a day for 3 to 6 weeks. This treatment schedule can be inconvenient and costly for elderly, rural, uninsured, and minority patients. This study will evaluate a new radiation treatment schedule called whole-breast accelerated hypofractionated radiotherapy (AHF-RT). AHF-RT delivers higher doses of radiation in fewer treatments than traditional radiation therapy. The AHF-RT treatment course is completed with 5 radiation treatments delivered once a week for 5 weeks.
The purpose of this study is to determine if accelerated hypofractionated radiotherapy (AHF-RT) is a safe, effective, more convenient, and less costly alternative to traditional radiation that will offer the same chance of cure with no additional side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AHF-RT | Experimental | Radiation: accelerated hypofractionated radiotherapy (AHF-RT)accelerated hypofractionated radiotherapy (AHF-RT) 30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Only women who satisfy all of the following conditions will be eligible for this study.
- must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
- must be at least 21 years old
- must have stage 0, I, or II breast cancer
- On histological examination, the tumor must be ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast.
Key exclusion criteria (20 listed)
- Men are not eligible for this study. Women with one or more of the following conditions are ineligible for this study.
- T3, stage III, or stage IV breast cancer
- More than 3 histologically positive axillary nodes
- Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
- One or more positive non-axillary sentinel node(s) (Note that intramammary nodes are staged as axillary nodes.)
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 |
|---|---|---|
| accelerated hypofractionated radiotherapy (AHF-RT)Also: accelerated hypofractionated radiation30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy | Radiation | AHF-RT |
Primary outcome
Ipsilateral Breast Tumor Recurrence (IBTR)
Time frame: at 5 years post completion of AHF-RT
Both invasive and non-invasive IBTRs will be considered in calculating the primary endpoint.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Harriet Eldredge-Hindy, MD principal investigator
James Graham Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing accelerated hypofractionated radiotherapy (AHF-RT) in people with Breast Cancer, run by University of Louisville at 1 site 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 14 inclusion and 20 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 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ipsilateral Breast Tumor Recurrence (IBTR) (time frame: at 5 years post completion of AHF-RT). 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 22 Feb 2024.