Breast CancerPhase 2APBINCT03940248

Proton Accelerated Partial Breast Irradiation

A Phase 2 study testing Proton Accelerated Partial Breast Irradiation in people with Breast Cancer, run by University of Cincinnati at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

Who is it for?: Ages 50 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Proton Accelerated Partial Breast Irradiation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2020to 8 Jul 2021
Phase: Phase 2
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

Who may be able to join

The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
Patients must be ≥ 50 years old.
Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.
On histologic examination, the tumor must be ductal carcinoma in situ (low or intermediate grade), invasive ductal carcinoma (any grade), or invasive lobular carcinoma.

Show all 11Show fewer

Patients must have unicentric disease with limited or focal lymphovascular space invasion (LVSI).
Patients must have an estrogen reception (ER) analysis performed and the primary tumor should be ER positive.
The target partial mastectomy cavity must be clearly delineated and the target partial mastectomy cavity/whole breast reference volume must be ≤ 30% based on the post- operative scan. The partial mastectomy cavity must be > 5mm from the skin. This can be confirmed at time of CT simulation for radiation treatment planning.
Patients must enroll within 42 days following the last surgery for breast cancer (partial mastectomy or re-excision of margins).
Proton APBI should start within 12 weeks from the time of surgery.

Who cannot join

Male
Patients < 50 years of age.
Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
Patients with persistently positive margins despite attempted re-excision.
Proven multicentric disease or extensive LVSI.

Show all 16Show fewer

Clear delineation of the extent of the target partial mastectomy cavity is not possible.
Patients who have undergone oncoplastic reconstruction.
Any patients who received neoadjuvant chemotherapy or hormonal therapy prior to surgical excision of the tumor.
Any patients who require adjuvant chemotherapy following lumpectomy.
Patients whose primary tumor is ER negative.
Patients with high grade ductal carcinoma in situ.
Patients with known BRCA1 or BRCA2 mutation.
Prior breast or thoracic radiation and any prior breast surgery in the ipsilateral breast.
Patients with history of collagen vascular disease including scleroderma, lupus, polymyositis, or dermatomyositis.
Pregnancy.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Cincinnati
Cincinnati, Ohio, 45267

Other trials in United States

About this study

Official title: Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer

This prospective, non-randomized phase II study will evaluate the cosmetic outcome of using pencil beam scanning proton therapy for partial breast irradiation in patients diagnosed with early stage breast cancer. In addition the study will evaluate the acute and late toxicities, and the rates of ipsilateral breast tumor recurrence, both in situ and invasive disease.

To qualify for the trial, patients must be 50 years or older and have stage 0 (carcinoma in situ) or stage IA or IIA invasive carcinoma of the breast with no evidence of metastatic disease. The tumor size must be 3cm or less. Women must have undergone a partial mastectomy with margins free of invasive cancer and at least a 2mm margin for in situ disease. Patients must have clinically node negative disease. Patients with invasive disease must also have nodal assessment performed with either sentinel lymph node biopsy or axillary lymph node dissection and patients must have pathologically node negative disease. Accelerated partial breast irradiation (APBI) will utilize pencil beam scanning proton therapy. Partial breast irradiation will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

This trial is designed to accrue 21 patients over a period of three years.

Conditions: Breast Cancer
Being tested: Proton Accelerated Partial Breast Irradiation
Keywords: Proton Therapy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Proton Accelerated Partial Breast IrradiationRadiation
38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions

Study groups in NCT03940248
Study group	Role	What they receive
Early Stage Breast Cancer	Experimental	Patients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days. Receives: Radiation: Proton Accelerated Partial Breast Irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Cosmetic outcome (change in appearance as compared to untreated breast)
Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]
Measured: Through Study Completion, an average of 2 years
Cosmetic outcome (change in appearance as compared to untreated breast)
Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]
Measured: Through Study Completion, an average of 2 years

Secondary outcomes (4)

Rates of acute (within 3 months of treatment) toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Through Study Completion, an average of 2 years
Rates of late (> 3 months after treatment) toxicity
Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Through Study Completion, an average of 2 years
Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease.
Presence of invasive or ductal carcinoma in-situ in ipsilateral breast as confirmed by biopsy
Measured: Through Study Completion, an average of 2 years
Rate of regional recurrence
Presence of tumor in the ipsilateral axillary, infraclavicular, supraclavicular or internal mammary lymph nodes.
Measured: Through Study Completion, an average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20208 Jul 2021

First posted7 May 2019
Study start1 Jul 2020
Primary completion8 Jul 2021
Study completion8 Jul 2021

Why it stopped: Due to insurance non-payment, no subjects were enrolled.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03940248
Sponsor's protocol ID: 2019-0088
Acronym: APBI
Status last verified: Sep 2021
First submitted: 22 Apr 2019
Last updated: 6 Oct 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Howlader N, N.A., Krapcho M, Miller D, Bishop K, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). . SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. . 2017; Available from: https://seer.cancer.gov/csr/1975_2014/
van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.
PubMed 10904087
Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
PubMed 12393820
Byun, D.J., et al., Omission of Adjuvant Radiation Therapy Following Breast Conservation Surgery for Ductal Carcinoma In Situ: Analysis of the National Cancer Data Base. International Journal of Radiation Oncology • Biology • Physics. 96(2): p. E38.
Feigelson HS, Carroll NM, Weinmann S, Haque R, Yu CL, Butler MG, Waitzfelder B, Wrenn MG, Capra A, McGlynn EA, Habel LA. Treatment patterns for ductal carcinoma in situ from 2000-2010 across six integrated health plans. Springerplus. 2015 Jan 17;4:24. doi: 10.1186/s40064-014-0776-7. eCollection 2015.
PubMed 25625043
Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10. doi: 10.1016/s0360-3016(00)00782-3.
PubMed 11121627
Fernando IN, Ford HT, Powles TJ, Ashley S, Glees JP, Torr M, Grafton D, Harmer CL. Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol). 1996;8(4):226-33. doi: 10.1016/s0936-6555(05)80657-0.
PubMed 8871000
Krauss DJ, Kestin LL, Mitchell C, Martinez AA, Vicini FA. Changes in temporal patterns of local failure after breast-conserving therapy and their prognostic implications. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):731-40. doi: 10.1016/j.ijrobp.2004.04.010.
PubMed 15465189
Polgar C, Fodor J, Major T, Nemeth G, Lovey K, Orosz Z, Sulyok Z, Takacsi-Nagy Z, Kasler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. doi: 10.1016/j.ijrobp.2007.04.022. Epub 2007 May 25.
PubMed 17531400
Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
PubMed 19910132
Chafe S, Moughan J, McCormick B, Wong J, Pass H, Rabinovitch R, Arthur DW, Petersen I, White J, Vicini FA. Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):854-9. doi: 10.1016/j.ijrobp.2013.04.005. Epub 2013 May 29.
PubMed 23726000
Vaidya JS, Bulsara M, Wenz F, Coombs N, Singer J, Ebbs S, Massarut S, Saunders C, Douek M, Williams NR, Joseph D, Tobias JS, Baum M. Reduced Mortality With Partial-Breast Irradiation for Early Breast Cancer: A Meta-Analysis of Randomized Trials. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):259-265. doi: 10.1016/j.ijrobp.2016.05.008. Epub 2016 May 13.
PubMed 27478165
Correa C, Harris EE, Leonardi MC, Smith BD, Taghian AG, Thompson AM, White J, Harris JR. Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement. Pract Radiat Oncol. 2017 Mar-Apr;7(2):73-79. doi: 10.1016/j.prro.2016.09.007. Epub 2016 Sep 17.
PubMed 27866865
Wang X, Amos RA, Zhang X, Taddei PJ, Woodward WA, Hoffman KE, Yu TK, Tereffe W, Oh J, Perkins GH, Salehpour M, Zhang SX, Sun TL, Gillin M, Buchholz TA, Strom EA. External-beam accelerated partial breast irradiation using multiple proton beam configurations. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1464-72. doi: 10.1016/j.ijrobp.2010.04.052. Epub 2010 Aug 12.
PubMed 20708848
Taghian AG, Kozak KR, Katz A, Adams J, Lu HM, Powell SN, DeLaney TF. Accelerated partial breast irradiation using proton beams: Initial dosimetric experience. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1404-10. doi: 10.1016/j.ijrobp.2006.03.017. Epub 2006 May 26.
PubMed 16730137

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study to Evaluate the Cosmetic Outcome of Using Pencil Beam Scanning Proton Therapy for Accelerated Partial Breast Irradiation in Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT03940248
Acronym / sponsor ID: APBI / 2019-0088
Conditions: Breast Cancer
Keywords: Proton Therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Due to insurance non-payment, no subjects were enrolled.
Enrolment: 0 participants (actual)
Lead sponsor: University of CincinnatiUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: 8 Jul 2021 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 7 May 2019 (actual)
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 trial is designed to accrue 21 patients over a period of three years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Early Stage Breast Cancer	Experimental	Radiation: Proton Accelerated Partial Breast IrradiationPatients to be treated with Accelerated Partial Breast Irradiation utilizing pencil beam scanning proton therapy. Treatment will be delivered twice a day, at least 6 hours apart, over 5 treatment days.

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The patient must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
Patients must be ≥ 50 years old.
Patients should have a life expectancy of at least 10 years taking into consideration comorbid conditions.
Surgical treatment of the breast must have been partial mastectomy. The margins of the resected specimen must be histologically free of tumor for invasive disease and with at least a 2mm margin for in situ disease. Reexcision of surgical margins is permitted to obtain negative margins. Postoperative mammogram of the surgical specimen or breast must be performed to confirm that all abnormal calcifications were removed at the time of surgery. Surgical clips must be placed at the partial mastectomy site by the surgeon at the time of excision.
Patients must have American Joint Committee on Cancer 8th edition pathology stage Tis, T1, or T2 and N0 as assessed by sentinel lymph node biopsy or axillary lymph node dissection for invasive disease. The tumor size must be 3cm or less in greatest dimension.

Key exclusion criteria (16 listed)

Male
Patients < 50 years of age.
Tumor > 3cm in greatest dimension or American Joint Committee on Cancer 8th edition pathologic stage T3 or T4 or node positive disease.
If patients have invasive carcinoma and no nodal assessment was performed, specifically the patient did not undergo sentinel lymph node biopsy or axillary lymph node dissection.
Patients with persistently positive margins despite attempted re-excision.

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
Proton Accelerated Partial Breast Irradiation38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions	Radiation	Early Stage Breast Cancer

Primary outcome

Cosmetic outcome (change in appearance as compared to untreated breast)
Time frame: Through Study Completion, an average of 2 years
Breast Cancer Treatment Outcome Scale [8 (no difference) through 32 (large difference)]
Cosmetic outcome (change in appearance as compared to untreated breast)
Time frame: Through Study Completion, an average of 2 years
Physician and Nurse Harvard Cosmesis Scale [1 (excellent) through 4 (poor)]

4 secondary outcomes

Rates of acute (within 3 months of treatment) toxicity
Time frame: Through Study Completion, an average of 2 years
Rates of late (> 3 months after treatment) toxicity
Time frame: Through Study Completion, an average of 2 years
Rate of ipsilateral breast tumor recurrence, including both in situ and invasive disease.
Time frame: Through Study Completion, an average of 2 years
Rate of regional recurrence
Time frame: Through Study Completion, an average of 2 years

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
BackgroundHowlader N, N.A., Krapcho M, Miller D, Bishop K, Kosary CL, Yu M, Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). . SEER Cancer Statistics Review, 1975-2014, National Cancer Institute. . 2017; Available from: https://seer.cancer.gov/csr/1975_2014/
Background: PubMed 10904087van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.
Background: PubMed 12393820Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.
BackgroundByun, D.J., et al., Omission of Adjuvant Radiation Therapy Following Breast Conservation Surgery for Ductal Carcinoma In Situ: Analysis of the National Cancer Data Base. International Journal of Radiation Oncology • Biology • Physics. 96(2): p. E38.
Background: PubMed 25625043Feigelson HS, Carroll NM, Weinmann S, Haque R, Yu CL, Butler MG, Waitzfelder B, Wrenn MG, Capra A, McGlynn EA, Habel LA. Treatment patterns for ductal carcinoma in situ from 2000-2010 across six integrated health plans. Springerplus. 2015 Jan 17;4:24. doi: 10.1186/s40064-014-0776-7. eCollection 2015.
Background: PubMed 11121627Fisher J, Scott C, Stevens R, Marconi B, Champion L, Freedman GM, Asrari F, Pilepich MV, Gagnon JD, Wong G. Randomized phase III study comparing Best Supportive Care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97-13. Int J Radiat Oncol Biol Phys. 2000 Dec 1;48(5):1307-10. doi: 10.1016/s0360-3016(00)00782-3.
Background: PubMed 8871000Fernando IN, Ford HT, Powles TJ, Ashley S, Glees JP, Torr M, Grafton D, Harmer CL. Factors affecting acute skin toxicity in patients having breast irradiation after conservative surgery: a prospective study of treatment practice at the Royal Marsden Hospital. Clin Oncol (R Coll Radiol). 1996;8(4):226-33. doi: 10.1016/s0936-6555(05)80657-0.
Background: PubMed 15465189Krauss DJ, Kestin LL, Mitchell C, Martinez AA, Vicini FA. Changes in temporal patterns of local failure after breast-conserving therapy and their prognostic implications. Int J Radiat Oncol Biol Phys. 2004 Nov 1;60(3):731-40. doi: 10.1016/j.ijrobp.2004.04.010.
Background: PubMed 17531400Polgar C, Fodor J, Major T, Nemeth G, Lovey K, Orosz Z, Sulyok Z, Takacsi-Nagy Z, Kasler M. Breast-conserving treatment with partial or whole breast irradiation for low-risk invasive breast carcinoma--5-year results of a randomized trial. Int J Radiat Oncol Biol Phys. 2007 Nov 1;69(3):694-702. doi: 10.1016/j.ijrobp.2007.04.022. Epub 2007 May 25.
Background: PubMed 19910132Vicini F, Winter K, Wong J, Pass H, Rabinovitch R, Chafe S, Arthur D, Petersen I, White J, McCormick B. Initial efficacy results of RTOG 0319: three-dimensional conformal radiation therapy (3D-CRT) confined to the region of the lumpectomy cavity for stage I/ II breast carcinoma. Int J Radiat Oncol Biol Phys. 2010 Jul 15;77(4):1120-7. doi: 10.1016/j.ijrobp.2009.06.067. Epub 2009 Nov 10.
Background: PubMed 23726000Chafe S, Moughan J, McCormick B, Wong J, Pass H, Rabinovitch R, Arthur DW, Petersen I, White J, Vicini FA. Late toxicity and patient self-assessment of breast appearance/satisfaction on RTOG 0319: a phase 2 trial of 3-dimensional conformal radiation therapy-accelerated partial breast irradiation following lumpectomy for stages I and II breast cancer. Int J Radiat Oncol Biol Phys. 2013 Aug 1;86(5):854-9. doi: 10.1016/j.ijrobp.2013.04.005. Epub 2013 May 29.
Background: PubMed 27478165Vaidya JS, Bulsara M, Wenz F, Coombs N, Singer J, Ebbs S, Massarut S, Saunders C, Douek M, Williams NR, Joseph D, Tobias JS, Baum M. Reduced Mortality With Partial-Breast Irradiation for Early Breast Cancer: A Meta-Analysis of Randomized Trials. Int J Radiat Oncol Biol Phys. 2016 Oct 1;96(2):259-265. doi: 10.1016/j.ijrobp.2016.05.008. Epub 2016 May 13.
Surveillance, Epidemiology and End Results Cancer Statistics ReviewLink provided by the sponsor.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Proton Accelerated Partial Breast Irradiation in people with Breast Cancer, run by University of Cincinnati 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 11 inclusion and 16 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: withdrawn, as of the sponsor's last update on 6 Oct 2021. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Cosmetic outcome (change in appearance as compared to untreated breast) (time frame: Through Study Completion, an average of 2 years). The study lists 2 primary outcomes in all. 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 NCT03940248, which also lists 26 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 6 Oct 2021.