Breast CancerBR01NCT01365845
Proton Therapy for Lymph Nodes in Breast Cancer
A study testing Photon and 3D-Proton/Conventional plan or 3D-proton only in people with Breast Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Photon and 3D-Proton/Conventional plan or 3D-proton only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 23 May 2018
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
- Patients must have undergone either mastectomy or breast conservation surgery.
- Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
- Patient must require peripheral lymph node radiation per physician discretion.
Who cannot join
- Evidence of distant metastasis (M1).
- Prior radiotherapy to the area of interest.
- Prior history of cardiovascular disease per physician discretion.
- Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
The purpose of this study is to determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.
- Conditions
- Breast Cancer
- Being tested
- Photon, 3D-Proton/Conventional plan or 3D-proton only
- Keywords
- Proton Radiation, 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.
PhotonRadiation
50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
3D-Proton/Conventional plan or 3D-proton onlyRadiation
50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Conventional photon plan Receives: Radiation: Photon |
| 2 | Experimental | 3D-Proton/Conventional plan or 3D-proton only Receives: Radiation: 3D-Proton/Conventional plan or 3D-proton only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.
Measured: 2 weeks prior to starting radiation therapy.
Secondary outcomes (4)
Secondary Dosimetric Endpoint
Assess improvements in other dosimetry endpoints including lung dose (mean lung dose, V20, V5), heart dose (mean heart, V20, V5), mean dose to the thyroid, mean esophageal dose, D95 coverage for axillary, supraclavicular and internal mammary nodes, maximal spinal cord dose (Dmax) and skin Dmax.
Measured: 2 weeks prior to starting radiation therapy.
Assessment of Acute Side Effects
Assess acute toxicities including pericarditis, pneumonitis, dermatitis, fatigue, and nausea.
Measured: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
Assessment of Longterm Side Effects and Disease Specific End Points.
Assess late toxicities including clinical and sub-clinical heart disease, pulmonary fibrosis, soft tissue fibrosis, rib fracture, and secondary malignancies.
Analyze local control, progression-free survival, and overall survival.
Measured: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
Assessment of Cardiac Function Markers
Assess levels of cardiac function markers Troponin and Brain Naturietic Peptide before and after treatment.
Measured: after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startApr 2012
- Primary completionMar 2014
- Study completion23 May 2018
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.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie A Bradley, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365845
- Sponsor's protocol ID
- IRB201701740
- Other IDs
- UFPTI 1016-BR01
- Acronym
- BR01
- Status last verified
- May 2018
- First submitted
- 19 May 2011
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
PubMed 18287387Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
PubMed 16360786Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, Kjaer M, Gadeberg CC, Mouridsen HT, Jensen MB, Zedeler K. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997 Oct 2;337(14):949-55. doi: 10.1056/NEJM199710023371401.
PubMed 9395428Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, Kamby C, Kjaer M, Gadeberg CC, Rasmussen BB, Blichert-Toft M, Mouridsen HT. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999 May 15;353(9165):1641-8. doi: 10.1016/S0140-6736(98)09201-0.
PubMed 10335782Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, Wilson KS, Knowling MA, Coppin CM, Paradis M, Coldman AJ, Olivotto IA. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997 Oct 2;337(14):956-62. doi: 10.1056/NEJM199710023371402.
PubMed 9309100Heuts EM, van der Ent FW, von Meyenfeldt MF, Voogd AC. Internal mammary lymph drainage and sentinel node biopsy in breast cancer - A study on 1008 patients. Eur J Surg Oncol. 2009 Mar;35(3):252-7. doi: 10.1016/j.ejso.2008.06.1493. Epub 2008 Aug 5.
PubMed 18684584Farrus B, Vidal-Sicart S, Velasco M, Zanon G, Fernandez PL, Munoz M, Santamaria G, Albanell J, Biete A. Incidence of internal mammary node metastases after a sentinel lymph node technique in breast cancer and its implication in the radiotherapy plan. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):715-21. doi: 10.1016/j.ijrobp.2004.04.021.
PubMed 15465187TURNER-WARWICK RT. The lymphatics of the breast. Br J Surg. 1959 May;46:574-82. doi: 10.1002/bjs.18004620004. No abstract available.
PubMed 13839973Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.
PubMed 18723148Veronesi U, Arnone P, Veronesi P, Galimberti V, Luini A, Rotmensz N, Botteri E, Ivaldi GB, Leonardi MC, Viale G, Sagona A, Paganelli G, Panzeri R, Orecchia R. The value of radiotherapy on metastatic internal mammary nodes in breast cancer. Results on a large series. Ann Oncol. 2008 Sep;19(9):1553-60. doi: 10.1093/annonc/mdn183. Epub 2008 May 7.
PubMed 18467318Freedman GM, Fowble BL, Nicolaou N, Sigurdson ER, Torosian MH, Boraas MC, Hoffman JP. Should internal mammary lymph nodes in breast cancer be a target for the radiation oncologist? Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):805-14. doi: 10.1016/s0360-3016(99)00481-2.
PubMed 10705000Veronesi U, Marubini E, Mariani L, Valagussa P, Zucali R. The dissection of internal mammary nodes does not improve the survival of breast cancer patients. 30-year results of a randomised trial. Eur J Cancer. 1999 Sep;35(9):1320-5. doi: 10.1016/s0959-8049(99)00133-1.
PubMed 10658521Arriagada R, Le MG, Mouriesse H, Fontaine F, Dewar J, Rochard F, Spielmann M, Lacour J, Tubiana M, Sarrazin D. Long-term effect of internal mammary chain treatment. Results of a multivariate analysis of 1195 patients with operable breast cancer and positive axillary nodes. Radiother Oncol. 1988 Mar;11(3):213-22. doi: 10.1016/0167-8140(88)90003-5.
PubMed 3363169Cuzick J, Stewart H, Rutqvist L, Houghton J, Edwards R, Redmond C, Peto R, Baum M, Fisher B, Host H, et al. Cause-specific mortality in long-term survivors of breast cancer who participated in trials of radiotherapy. J Clin Oncol. 1994 Mar;12(3):447-53. doi: 10.1200/JCO.1994.12.3.447.
PubMed 8120544Hojris I, Overgaard M, Christensen JJ, Overgaard J. Morbidity and mortality of ischaemic heart disease in high-risk breast-cancer patients after adjuvant postmastectomy systemic treatment with or without radiotherapy: analysis of DBCG 82b and 82c randomised trials. Radiotherapy Committee of the Danish Breast Cancer Cooperative Group. Lancet. 1999 Oct 23;354(9188):1425-30. doi: 10.1016/s0140-6736(99)02245-x.
PubMed 10543669
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Therapy for Peripheral Lymph Nodes in Breast Cancer
- ClinicalTrials.gov ID
- NCT01365845
- Acronym / sponsor ID
- BR01 / IRB201701740
- Conditions
- Breast Cancer
- Keywords
- Proton Radiation, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Mar 2014 (actual)
- Study completion
- 23 May 2018 (actual)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Posted 5 Dec 2014
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 determine if proton radiation therapy will reduce the amount of heart that is exposed to radiation, thereby decreasing the frequency and/or severity of any cardiac side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Radiation: PhotonConventional photon plan |
| 2 | Experimental | Radiation: 3D-Proton/Conventional plan or 3D-proton only3D-Proton/Conventional plan or 3D-proton only |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically confirmed invasive adenocarcinoma of the breast stage I-III (TX, T0-4, N0-3) with medially located tumor and/or axillary node invasion.
- Patients must have undergone either mastectomy or breast conservation surgery.
- Patients are required to have axillary staging which can include sentinel node biopsy alone if sentinel node is negative.
- Patient must require peripheral lymph node radiation per physician discretion.
Key exclusion criteria (5 listed)
- Evidence of distant metastasis (M1).
- Prior radiotherapy to the area of interest.
- Prior history of cardiovascular disease per physician discretion.
- Prior or concurrent cancer other than non-melanomatous skin cancer unless disease free for at least 5 years.
- Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis or scleroderma.
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 |
|---|---|---|
| Photon50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction | Radiation | 1 |
| 3D-Proton/Conventional plan or 3D-proton only50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction | Radiation | 2 |
Primary outcome
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE)
Time frame: 2 weeks prior to starting radiation therapy.
A reduction of 50% in heart volume exposed to radiation doses ≥ 5 Gy/CGE was considered preferred outcome in this study plan.
4 secondary outcomes
Secondary Dosimetric Endpoint
Time frame: 2 weeks prior to starting radiation therapy.
Assessment of Acute Side Effects
Time frame: Participants will be assessed weekly during radiation therapy for an expected average of 7 weeks.
Assessment of Longterm Side Effects and Disease Specific End Points.
Time frame: 1 month following completion of treatment, then every 6 months for 5 years, then annually thereafter.
Assessment of Cardiac Function Markers
Time frame: after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18287387Jemal A, Siegel R, Ward E, Hao Y, Xu J, Murray T, Thun MJ. Cancer statistics, 2008. CA Cancer J Clin. 2008 Mar-Apr;58(2):71-96. doi: 10.3322/CA.2007.0010. Epub 2008 Feb 20.
- Background: PubMed 16360786Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.
- Background: PubMed 9395428Overgaard M, Hansen PS, Overgaard J, Rose C, Andersson M, Bach F, Kjaer M, Gadeberg CC, Mouridsen HT, Jensen MB, Zedeler K. Postoperative radiotherapy in high-risk premenopausal women with breast cancer who receive adjuvant chemotherapy. Danish Breast Cancer Cooperative Group 82b Trial. N Engl J Med. 1997 Oct 2;337(14):949-55. doi: 10.1056/NEJM199710023371401.
- Background: PubMed 10335782Overgaard M, Jensen MB, Overgaard J, Hansen PS, Rose C, Andersson M, Kamby C, Kjaer M, Gadeberg CC, Rasmussen BB, Blichert-Toft M, Mouridsen HT. Postoperative radiotherapy in high-risk postmenopausal breast-cancer patients given adjuvant tamoxifen: Danish Breast Cancer Cooperative Group DBCG 82c randomised trial. Lancet. 1999 May 15;353(9165):1641-8. doi: 10.1016/S0140-6736(98)09201-0.
- Background: PubMed 9309100Ragaz J, Jackson SM, Le N, Plenderleith IH, Spinelli JJ, Basco VE, Wilson KS, Knowling MA, Coppin CM, Paradis M, Coldman AJ, Olivotto IA. Adjuvant radiotherapy and chemotherapy in node-positive premenopausal women with breast cancer. N Engl J Med. 1997 Oct 2;337(14):956-62. doi: 10.1056/NEJM199710023371402.
- Background: PubMed 18684584Heuts EM, van der Ent FW, von Meyenfeldt MF, Voogd AC. Internal mammary lymph drainage and sentinel node biopsy in breast cancer - A study on 1008 patients. Eur J Surg Oncol. 2009 Mar;35(3):252-7. doi: 10.1016/j.ejso.2008.06.1493. Epub 2008 Aug 5.
- Background: PubMed 15465187Farrus B, Vidal-Sicart S, Velasco M, Zanon G, Fernandez PL, Munoz M, Santamaria G, Albanell J, Biete A. Incidence of internal mammary node metastases after a sentinel lymph node technique in breast cancer and its implication in the radiotherapy plan. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):715-21. doi: 10.1016/j.ijrobp.2004.04.021.
- Background: PubMed 13839973TURNER-WARWICK RT. The lymphatics of the breast. Br J Surg. 1959 May;46:574-82. doi: 10.1002/bjs.18004620004. No abstract available.
- Background: PubMed 18723148Avisar E, Molina MA, Scarlata M, Moffat FL. Internal mammary sentinel node biopsy for breast cancer. Am J Surg. 2008 Oct;196(4):490-4. doi: 10.1016/j.amjsurg.2008.06.003. Epub 2008 Aug 23.
- Background: PubMed 18467318Veronesi U, Arnone P, Veronesi P, Galimberti V, Luini A, Rotmensz N, Botteri E, Ivaldi GB, Leonardi MC, Viale G, Sagona A, Paganelli G, Panzeri R, Orecchia R. The value of radiotherapy on metastatic internal mammary nodes in breast cancer. Results on a large series. Ann Oncol. 2008 Sep;19(9):1553-60. doi: 10.1093/annonc/mdn183. Epub 2008 May 7.
- Background: PubMed 10705000Freedman GM, Fowble BL, Nicolaou N, Sigurdson ER, Torosian MH, Boraas MC, Hoffman JP. Should internal mammary lymph nodes in breast cancer be a target for the radiation oncologist? Int J Radiat Oncol Biol Phys. 2000 Mar 1;46(4):805-14. doi: 10.1016/s0360-3016(99)00481-2.
- Background: PubMed 10658521Veronesi U, Marubini E, Mariani L, Valagussa P, Zucali R. The dissection of internal mammary nodes does not improve the survival of breast cancer patients. 30-year results of a randomised trial. Eur J Cancer. 1999 Sep;35(9):1320-5. doi: 10.1016/s0959-8049(99)00133-1.
- University of Florida Proton Therapy Institute websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Julie A Bradley, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon and 3D-Proton/Conventional plan or 3D-proton only in people with Breast Cancer, run by University of Florida 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 4 inclusion and 5 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 29 Jun 2018. 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 5 Dec 2014). 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?
Volume of Heart Receiving ≥ 5 Gray (Gy)/Cobalt Gray Equivalent (CGE) (time frame: 2 weeks prior to starting radiation therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01365845, which also lists 22 linked publications.
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 29 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.