Early Stage Breast CancerPhase 1NCT01162200
Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
A Phase 1 study testing Stereotactic Body Radiation Therapy in people with Early Stage Breast Cancer, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial summary
By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve… Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Oct 2010to 28 Dec 2015
- Phase
- Phase 1
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DCIS or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies.
- Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 (≤3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible.
- The patient's Zubrod performance status must be 0-2.
- Patients must be ≥ 18 years of age.
- If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy.
- Unifocal breast cancer (no evidence of gross multifocal disease, multicentric, or bilateral disease.
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- Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >2 mm clear of tumor in all directions).
- Negative post- lumpectomy mammography if malignancy-associated microcalcifications were initially present.
- The target lumpectomy cavity must be clearly delineated.
- Patients must complete appropriate pretreatment evaluation, including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal.
Who cannot join
- Evidence of suspicious microcalcifications in the breast prior to start of radiation.
- Patients with history of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
- Patients with 4 or more histologically positive axillary nodes if axillary dissection is performed.
- Patients with distant metastases.
- Patients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma.
- Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy.
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- Patients must not have any 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.
- Any previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinoma.
- Prior non-hormonal therapy or radiation therapy for the current breast cancer or hormonal therapy for > 28 days after diagnosis or refusal to discontinue hormonal therapy.
- Patients with Paget's disease of the nipple
- Patients with prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
- Patients with severe, active co-morbidity.
- Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent.
- Patients who are pregnant or lactating.
- Previous breast radiation on either side or thoracic radiation on the ipsilateral side..
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation TherapyRadiation
Also called SBRT
3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | SBRT dose per fraction Receives: Radiation: Stereotactic Body Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer
To escalate the dose of stereotactic radiotherapy utilizing the Cyberknife system to a tumorcidal dose to the lumpectomy cavity without exceeding the maximum tolerated dose in patients with early stage breast cancer.
Measured: 3 years
Secondary outcomes (2)
Dose-limiting toxicity
Measured: 3 years
The cosmesis of breast
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study start4 Oct 2010
- Primary completion25 Jul 2015
- Study completion28 Dec 2015
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
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asal Rahimi, MD, Principal investigator, UT Southwestern Medical Center Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162200
- Sponsor's protocol ID
- STU 072010-015
- Status last verified
- Jan 2019
- First submitted
- 2 Jul 2010
- Last updated
- 20 Aug 2020
- 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 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01162200
- Acronym / sponsor ID
- STU 072010-015
- Conditions
- Early Stage Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 4 Oct 2010 (actual)
- Primary completion
- 25 Jul 2015 (actual)
- Study completion
- 28 Dec 2015 (actual)
- First posted
- 14 Jul 2010 (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.
By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiation Therapy | Other | Radiation: Stereotactic Body Radiation TherapySBRT dose per fraction |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DCIS or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies.
- Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 (≤3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible.
- The patient's Zubrod performance status must be 0-2.
- Patients must be ≥ 18 years of age.
- If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy.
Key exclusion criteria (15 listed)
- Evidence of suspicious microcalcifications in the breast prior to start of radiation.
- Patients with history of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
- Patients with 4 or more histologically positive axillary nodes if axillary dissection is performed.
- Patients with distant metastases.
- Patients with invasive or extensive in-situ lobular carcinoma or 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 Body Radiation TherapyAlso: SBRT3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation). | Radiation | Stereotactic Body Radiation Therapy |
Primary outcome
The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer
Time frame: 3 years
To escalate the dose of stereotactic radiotherapy utilizing the Cyberknife system to a tumorcidal dose to the lumpectomy cavity without exceeding the maximum tolerated dose in patients with early stage breast cancer.
2 secondary outcomes
Dose-limiting toxicity
Time frame: 3 years
The cosmesis of breast
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
- 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.
Asal Rahimi, MD principal investigator
UT Southwestern Medical Center Dallas
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 Body Radiation Therapy 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 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: finished, as of the sponsor's last update on 20 Aug 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The maximum tolerated dose to the lumpectomy cavity in patients with early stage breast cancer (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 20 Aug 2020.