Anatomic Stage 0 Breast Cancer AJCC v8Phase 2NCT06008158
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca
A Phase 2 study testing Accelerated Partial Breast Irradiation in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- What is being tested?
- Accelerated Partial Breast Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2023to 26 May 2027
- Phase
- Phase 2
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented informed consent of the participant and/or legally authorized representative
- Age: >= 40 years
- Female
- Ability to read and understand English or Spanish for questionnaires
- Anatomic pathologic stage 0 (ductal carcinoma in situ [DCIS]) or stage IA (invasive) breast cancer
- Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphoma or sarcoma are not allowed
Show all 23Show fewer
- Tissue from core biopsy or resection must show hormone sensitive receptors. Hormone sensitive receptors are defined as the following:
- - DCIS: Estrogen receptor (ER) positive (>= 60%)
- Invasive breast cancer:
- Oncotype DX =< 25 (if performed) OR
- If Oncotype DX is not performed an Allred score of 7 or 8. The following combinations of proportion of ER positive cells and staining intensity are allowed:
- ER positive (34-66% of cells) and staining intensity is strong (Allred 7)
- ER positive (>= 67% of cells) and staining intensity is intermediate (Allred 7)
- ER positive (>= 67% of cells) and staining intensity is strong (Allred 8)
- Tissue from core biopsy or resection must be HER2 negative by current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Patients must have undergone breast conserving surgery with resulting negative surgical margins (no tumor on ink). Re-excision for negative margins is allowed. Patients with pathologically involved surgical margins are excluded
- Patients must have pathologic Tis or T1 disease
- Patients with invasive breast cancer, including patients with microinvasion, must have undergone surgical staging of the axilla (sentinel lymph node biopsy or axillary lymph node dissection) and have pathologically confirmed uninvolved lymph nodes. All lymph nodes must be pathologically negative (pN0[i-]). pN0(i+), pN1mic, pN1-pN3 axillary lymph nodes are not allowed Although an axillary lymph node dissection is not anticipated for low-risk ER positive breast cancers, axillary lymph node dissection is permissible
- Patient must have physician-reported "excellent" or "good" cosmesis post-lumpectomy and prior to radiation therapy based on the 4-point Global Cosmetic Score
- Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test.
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females of childbearing potential* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 month after the last dose of protocol therapy
- Childbearing potential is defined as not being surgically sterilized or have not been free from menses for > 1 year
Who cannot join
- Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation
- Clinically significant uncontrolled illness
- Diagnosis of Paget's disease of the nipple
- Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Pregnant or breastfeeding
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD.
SECONDARY OBJECTIVES:
- To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD.
II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD.
III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
- To determine the cancer control outcomes of APBI QD.
EXPLORATORY OBJECTIVES:
- To assess the health-related quality of life in patients treated with APBI QD.
II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI.
III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
OUTLINE:
Patients undergo APBI QD on consecutive business days for 5 treatments.
Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- Being tested
- Accelerated Partial Breast Irradiation
- Medical subject headings
- Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Partial Breast IrradiationRadiation
Also called Accelerated Partial Breast Radiation Therapy, APBI
Undergo APBI
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (APBI) | Experimental | Patients undergo APBI QD on consecutive business days for 5 treatments. Receives: Radiation: Accelerated Partial Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is >= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.
Measured: At 1 year post accelerated partial breast irradiation once daily (APBI QD)
Secondary outcomes (10)
Cosmetic outcome by the patient post-APBI QD
Measured by the GCS. Will be summarized and the percent and 95% confidence limits of the estimate will be calculated. Will also examine at cosmesis scores over time using analysis of variance (ANOVA).
Measured: Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Appropriate graphical methods will be used for visualization. Association between the assessment rating of cosmetic outcome based on photographic image by medical doctor (MD) and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Measured: At 1 year
Cosmetic outcome assessed by the physician post-APBI QD
Measured by the GCS. Will explore also examine change in scores over time using ANOVA. Association between the assessment rating of cosmetic outcome based on photographic image by MD and blinded reviewers will be calculated at each time point using Pearson's product-moment correlation coefficient.
Measured: Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years
Incidence of adverse events-patients reported
Scored by the Patient-Reported Outcome Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized using standard methods.
Measured: Up to 3 years post-APBI
Incidence of adverse events-treatment team reported
As scored by the treatment team using CTCAE version 5.0. Will be summarized using standard methods.
Measured: Up to 3 years post-APBI
In-breast recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Measured: Up to 5 years post-APBI QD
Regional recurrence
The Kaplan-Meier method will be used along with 95% confidence intervals.
Measured: Up to 5 years post-APBI QD
Distant metastases
The Kaplan-Meier method will be used along with 95% confidence intervals.
Measured: Up to 5 years post-APBI QD
Disease-free survival
The Kaplan-Meier method will be used along with 95% confidence intervals.
Measured: Up to 5 years post-APBI QD
Overall survival
The Kaplan-Meier method will be used along with 95% confidence intervals.
Measured: Up to 5 years post-APBI QD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start29 Sep 2023
- Primary completion26 May 2027 (estimated)
- Study completion26 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage 0 Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by City of Hope 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jose G Bazan, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008158
- Sponsor's protocol ID
- 23037
- Other IDs
- NCI-2023-05718, 23037, P30CA033572
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2023
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation in Low-Risk, Hormone-Responsive Breast Cancer
- ClinicalTrials.gov ID
- NCT06008158
- Acronym / sponsor ID
- 23037
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 48 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Sep 2023 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 May 2027 (estimated)
- First posted
- 23 Aug 2023 (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 phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer. APBI uses precise radiation beams to kill cancerous cells in a smaller area of the breast (partial breast) instead of the whole breast or chest area as in standard therapy. Additionally, APBI is given in a shorter course of treatment than whole breast radiation therapy, over fewer days instead of several weeks, with a lower total dose of radiation. APBI is currently given every other business day for a total of 5 treatments with excellent results; however, a shorter treatment duration could have similar or even better results. Undergoing APBI every day on consecutive business days for 5 treatments may result in an improved breast appearance for patients with low risk hormone responsive breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To establish that APBI delivered once per day (APBI QD) for low-risk breast cancer patients results in acceptable patient-reported cosmetic appearance of the breast at 1 year after completion of APBI QD.
SECONDARY OBJECTIVES:
- To determine the long-term patient-reported cosmetic appearance of the breast in patients treated with APBI QD.
II. To determine the short-term and long-term physician reported cosmetic appearance of the breast in patients treated with APBI QD.
III. To determine the acute and late patient-reported radiation toxicity of APBI QD.
IV. To determine the acute and late physician-reported radiation toxicity of APBI QD.
- To determine the cancer control outcomes of APBI QD.
EXPLORATORY OBJECTIVES:
- To assess the health-related quality of life in patients treated with APBI QD.
II. To determine the long-term blinded physician review of cosmetic appearance of the breast in patients treated with APBI.
III. To assess dosimetric parameters associated with cosmesis in patients undergoing APBI QD.
OUTLINE:
Patients undergo APBI QD on consecutive business days for 5 treatments.
Patients follow up at 1 month, 6 months, and 1 year post-APBI and then yearly until 5 years post-APBI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (APBI) | Experimental | Radiation: Accelerated Partial Breast IrradiationPatients undergo APBI QD on consecutive business days for 5 treatments. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Documented informed consent of the participant and/or legally authorized representative
- Age: >= 40 years
- Female
- Ability to read and understand English or Spanish for questionnaires
- Anatomic pathologic stage 0 (ductal carcinoma in situ [DCIS]) or stage IA (invasive) breast cancer
Key exclusion criteria (7 listed)
- Any prior treatment with radiation therapy, anti-endocrine/hormone therapy, chemotherapy or biologic therapy for the currently diagnosed breast cancer PRIOR to surgical resection
- Prior radiation to the region of the involved breast that in the opinion of the investigator would preclude partial breast irradiation
- Clinically significant uncontrolled illness
- Diagnosis of Paget's disease of the nipple
- Other prior or active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
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 Partial Breast IrradiationAlso: Accelerated Partial Breast Radiation Therapy, APBIUndergo APBI | Radiation | Supportive care (APBI) |
Primary outcome
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good")
Time frame: At 1 year post accelerated partial breast irradiation once daily (APBI QD)
Measured by the 4-point Global Cosmetic Score (GCS). The exact test will be used to test the hypothesis that the rate of cosmesis is >= 90% versus the null hypothesis that cosmesis is 74% or lower, at the 5% significance level.
10 secondary outcomes
Cosmetic outcome by the patient post-APBI QD
Time frame: Over time at baseline, day 5, 1 month, 6 months, 1 year, 2 years and 3 years
Cosmetic outcome assessed by the physician post-APBI QD
Time frame: At 1 year
Cosmetic outcome assessed by the physician post-APBI QD
Time frame: Over time at baseline, day 5, 1 month, 6 months 1 year, 2 years and 3 years
Incidence of adverse events-patients reported
Time frame: Up to 3 years post-APBI
Incidence of adverse events-treatment team reported
Time frame: Up to 3 years post-APBI
In-breast recurrence
Time frame: Up to 5 years post-APBI QD
Regional recurrence
Time frame: Up to 5 years post-APBI QD
Distant metastases
Time frame: Up to 5 years post-APBI QD
Disease-free survival
Time frame: Up to 5 years post-APBI QD
Overall survival
Time frame: Up to 5 years post-APBI QD
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 29 Jun 2026.
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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.
Jose G Bazan principal investigator
City of Hope Medical Center
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 Accelerated Partial Breast Irradiation in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage IA Breast Cancer AJCC v8, run by City of Hope Medical Center 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 23 inclusion and 7 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 29 Jun 2026. 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?
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?
Proportion of women that rate the cosmetic appearance of the breast as acceptable ("excellent" or "good") (time frame: At 1 year post accelerated partial breast irradiation once daily (APBI QD)). 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 29 Jun 2026.