Early Stage Breast CancerPhase 1NCT02685332
Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA
A Phase 1 study testing Stereotactic Radiation in people with Early Stage Breast Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
Radiation, Stereotactic Body Radiation Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Stereotactic Radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2016to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
- Willing and able to provide consent
- Age >=18 years.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
Show all 10Show fewer
- Surgical treatment of the breast with lumpectomy Clinical Target Volume (CTV) margin up to 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions). Re-excision of surgical margins is permitted.
- Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
- Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes). Patients with DCIS are not required to have axillary staging.
- Patients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 1 or more years prior to entry into the study
Who cannot join
- T2 (>3.0 cm), T3, stage III, or stage IV breast cancer
- More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension.
- Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor.
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
- Non epithelial breast malignancies such as sarcoma or lymphoma.
- Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters.
Show all 14Show fewer
- Synchronous bilateral invasive or non-invasive breast cancer.
- Paget's disease of the nipple.
- Previous breast radiation on ipsilateral side or thoracic radiation on the ipsilateral side.
- Treatment plan that includes regional nodal irradiation.
- Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. Endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy. Patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration.
- Patients with collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
- Pregnancy or lactation at the time of registration. For women of childbearing age, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.
- Patients with severe co-extensive comorbidities or significant psychiatric illness.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
NYU Winthrop Hospital
Mineola, New York, 11501
About this study
Official title: Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer
Radiation, Stereotactic Body Radiation Therapy.
Read the detailed description
In this protocol, we plan to use the uniqueness of the Cyberknife system to deliver an adjuvant single fraction radiation dose. We anticipate that this radiation deliver system will reduce toxicity and improve cosmesis. Extrapolating from an intra-operative body of work, this Phase I study will attempt to achieve a non-invasive low toxicity profile and maintain good to excellent cosmesis. In this effort, the Cyberknife system will be used to achieve high conformality and dose gradient.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Stereotactic Radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic RadiationRadiation
Also called SB-PBI
Stereotactic Body Partial Breast irradiation Step No. Fractions Dose per fraction
-1 1 20 0 (starting) 1 22.5
- 1 26.5
- 1 30
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Radiation | Experimental | Single Fraction Stereotactic Radiation. Step No. Fractions Dose per fraction
-1 1 20 0 (starting) 1 22.5
1. 1 26.5
2. 1 30 Receives: Radiation: Stereotactic Radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum tolerated dose
maximum tolerated radiation dose
Measured: 3 years
Secondary outcomes (2)
dose-limiting toxicity
dose-limiting toxicity for each dose level
Measured: 90 days
cosmesis
as evaluated by an independent panel judging from serial photography
Measured: follow up at month 3, 6, 12, 24, 36, 48, and 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study start31 Mar 2016
- Primary completion6 Jan 2026
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asal Rahimi, University of Texas Southwestern Medical Center
- Investigators
- Asal Rahimi, MD, Principal investigator, UTSW Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685332
- Sponsor's protocol ID
- STU 062015-085
- Status last verified
- Aug 2026
- First submitted
- 11 Feb 2016
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02685332
- Acronym / sponsor ID
- STU 062015-085
- Conditions
- Early Stage Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Mar 2016 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Feb 2016 (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.
Radiation, Stereotactic Body Radiation Therapy.
Detailed description
In this protocol, we plan to use the uniqueness of the Cyberknife system to deliver an adjuvant single fraction radiation dose. We anticipate that this radiation deliver system will reduce toxicity and improve cosmesis. Extrapolating from an intra-operative body of work, this Phase I study will attempt to achieve a non-invasive low toxicity profile and maintain good to excellent cosmesis. In this effort, the Cyberknife system will be used to achieve high conformality and dose gradient.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Radiation | Experimental | Radiation: Stereotactic RadiationSingle Fraction Stereotactic Radiation. Step No. Fractions Dose per fraction -1 1 20 0 (starting) 1 22.5 1. 1 26.5 2. 1 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
- Willing and able to provide consent
- Age >=18 years.
- Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Key exclusion criteria (14 listed)
- T2 (>3.0 cm), T3, stage III, or stage IV breast cancer
- More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension.
- Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor.
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
- Non epithelial breast malignancies such as sarcoma or lymphoma.
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 |
|---|---|---|
| Stereotactic RadiationAlso: SB-PBIStereotactic Body Partial Breast irradiation Step No. Fractions Dose per fraction -1 1 20 0 (starting) 1 22.5 1. 1 26.5 2. 1 30 | Radiation | Stereotactic Radiation |
Primary outcome
maximum tolerated dose
Time frame: 3 years
maximum tolerated radiation dose
2 secondary outcomes
dose-limiting toxicity
Time frame: 90 days
cosmesis
Time frame: follow up at month 3, 6, 12, 24, 36, 48, and 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Early Stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Asal Rahimi, MD principal investigator
UTSW Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic Radiation in people with Early Stage Breast Cancer, run by University of Texas Southwestern Medical Center at 2 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 10 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
maximum tolerated dose (time frame: 3 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 27 Aug 2026.