Anatomic Stage 0 Breast Cancer AJCC v8NCT04871516
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Boost in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Rutgers, The State University of New Jersey at 11 sites in United States.
Trial summary
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
- What is being tested?
- Quality-of-Life Assessment, Questionnaire Administration and Radiation Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 11 sitesUnited States
- Study dates
- 18 May 2021to 31 Jan 2028
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients with biopsy proven invasive cancer
- Clinically and radiographically node negative
- No indication of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Synchronous bilateral invasive cancer allowed
- Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery
- Willingness to participate in the clinical trial and adhere to the study protocol
- Individuals of all races, genders and ethnic groups are eligible for this trial
Who cannot join
- Need for neoadjuvant chemotherapy
- Inflammatory breast cancer (cT4)
- Multicentric tumor
- Prior ipsilateral breast or thoracic RT
- Contraindication for baseline magnetic resonance imaging (MRI)
- Contraindication for surgery
Show all 10Show fewer
- Distant metastatic disease
- Other synchronous cancer (besides bilateral breast)
- Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease)
- Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Clara Maass Medical Center
Belleville, New Jersey, 07109
RWJBarnabas Health-Trinitas Hospital and Comprehensive Care
Elizabeth, New Jersey, 07202
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690
RWJBarnabas Health Jersey City Medical Center
Jersey City, New Jersey, 07302
RWJBarnabas Health - Monmouth Medical Center Southern Campus
Lakewood, New Jersey, 08701
Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)
Livingston, New Jersey, 07039
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
RWJBarnabas Health - Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Robert Wood Johnson University Hospital Somerset
Somerville, New Jersey, 08876
RWJBarnabas Health - Community Medical Center
Toms River, New Jersey, 08755
About this study
Official title: A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
This phase II trial investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).
SECONDARY OBJECTIVE:
- To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).
TERTIARY/EXPLORATORY OBJECTIVES:
- To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.
II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.
III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.
IV. To study the cancer biology before and after radiation treatment.
OUTLINE:
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Being tested
- Quality-of-Life Assessment, Questionnaire Administration, Radiation Boost, Therapeutic Surgical Procedure, Whole 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.
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Radiation BoostRadiation
Also called Boost Radiation, Boost Radiation Therapy, Boost Radiotherapy, Radiation Therapy Boost
Undergo radiation therapy boost
Therapeutic Surgical ProcedureProcedure or surgery
Undergo standard surgery
Whole Breast IrradiationRadiation
Undergo standard WBI
Breast MRIOther
A baseline breast MRI
| Study group | Role | What they receive |
|---|---|---|
| Treatment (radiation therapy boost, WBI) | Experimental | Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity. Receives: Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Radiation Boost; Procedure: Therapeutic Surgical Procedure; Radiation: Whole Breast Irradiation; Other: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
Measured: For at least 36 months after WBI
Secondary outcomes (3)
Physician reported cosmesis
Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).
Measured: At 1 month after whole breast irradiation (WBI)
Physician reported cosmesis
Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor).
Measured: At 12 months after WBI
Physician reported cosmesis
Physician reported cosmesis will be assessed using the Harvard Cosmesis assessment Scale for Breast Cancer Patients which is a 4-point scale describing the breast cosmetic outcome (excellent, good, fair or poor). Will be reported as a proportion; CI will be calculated using the Clopper-Pearson model.
Measured: At 36 months after WBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start18 May 2021
- Primary completion5 Dec 2027 (estimated)
- Study completion31 Jan 2028 (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 Rutgers, The State University of New JerseyThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Bruce G Haffty, Rutgers Cancer Institute of New Jersey
- Investigators
- Bruce G Haffty, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871516
- Sponsor's protocol ID
- Pro2020001306
- Other IDs
- NCI-2020-05711, Pro2020001306, 042005, P30CA072720
- Status last verified
- Jan 2026
- First submitted
- 13 Oct 2020
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Phase II Prospective Clinical Trial to Assess the Feasibility of Preoperative Radiation Boost in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04871516
- Acronym / sponsor ID
- Pro2020001306
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 May 2021 (actual)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 4 May 2021 (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 investigates the safety of delivering a part (boost) of radiation treatment before breast surgery in treating patients with breast cancer that has not spread to other places in the body (non-metastatic). Radiation therapy uses high energy photons/electrons to kill tumor cells and shrink tumors. Delivering a boost radiation treatment before surgery when doctors can still visualize the tumor on imaging may help to better target the tumor and decrease the volume of normal irradiated tissue. By so doing, doctors may achieve better cosmetic outcomes and possibly better tumor control.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate that the incidence of grade 3 or more wound complications in patients with non-metastatic node negative breast cancer who are eligible for breast conserving surgery (BCS) and treated with pre-operative radiation boost at 1 month after end of whole breast radiation is no worse than the rates in the current standard of care (6-20%).
SECONDARY OBJECTIVE:
- To demonstrate that the physician reported cosmetic outcome at 1 and 3 years after the end of treatment is better than what has been reported for the current standard of practice for patients undergoing BCS and hypofractionated whole breast irradiation (WBI).
TERTIARY/EXPLORATORY OBJECTIVES:
- To measure the acute and late radiation related toxicities such as radiation dermatitis, telangiectasia and fibrosis in this cohort of patients.
II. To measure the pre-operative boost clinical target volume (CTV) and compare to the post-op CTV volume that would have been contoured as CTV if the boost was to be delivered post-operatively.
III. To measure the incidence of fair/poor patient reported cosmetic outcome using the Breast Cancer Treatment Outcomes Scale (BCTOS) cosmetic scale.
IV. To study the cancer biology before and after radiation treatment.
OUTLINE:
Prior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1, 3, 6, 9, 12, 18, and 24 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (radiation therapy boost, WBI) | Experimental | Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Radiation: Radiation Boost, Procedure: Therapeutic Surgical Procedure, Radiation: Whole Breast Irradiation, Other: Breast MRIPrior to surgery, patients undergo radiation therapy boost over 4 fractions. Patients then undergo standard of care surgery 1-3 weeks from the last day of boost. 3 to 5 weeks after surgery, patients continue standard of care WBI in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Breast cancer patients with biopsy proven invasive cancer
- Clinically and radiographically node negative
- No indication of metastatic disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Synchronous bilateral invasive cancer allowed
Key exclusion criteria (10 listed)
- Need for neoadjuvant chemotherapy
- Inflammatory breast cancer (cT4)
- Multicentric tumor
- Prior ipsilateral breast or thoracic RT
- Contraindication for baseline magnetic resonance imaging (MRI)
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 |
|---|---|---|
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Treatment (radiation therapy boost, WBI) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (radiation therapy boost, WBI) |
| Radiation BoostAlso: Boost Radiation, Boost Radiation Therapy, Boost Radiotherapy, Radiation Therapy BoostUndergo radiation therapy boost | Radiation | Treatment (radiation therapy boost, WBI) |
| Therapeutic Surgical ProcedureUndergo standard surgery | Procedure or surgery | Treatment (radiation therapy boost, WBI) |
| Whole Breast IrradiationUndergo standard WBI | Radiation | Treatment (radiation therapy boost, WBI) |
| Breast MRIA baseline breast MRI | Other | Treatment (radiation therapy boost, WBI) |
Primary outcome
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery.
Time frame: For at least 36 months after WBI
Wound complications will be assessed by the surgeon and radiation oncologist and graded using descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 5 (CTCAE v 5.0). This will be calculated as a proportion based on the number of events in the study. Will report the proportion with a 95% confidence interval (CI) using the Clopper-Pearson method.
3 secondary outcomes
Physician reported cosmesis
Time frame: At 1 month after whole breast irradiation (WBI)
Physician reported cosmesis
Time frame: At 12 months after WBI
Physician reported cosmesis
Time frame: At 36 months after WBI
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 22 Jan 2026.
- 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.
Bruce G Haffty principal investigator
Rutgers Cancer Institute of New Jersey
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality-of-Life Assessment, Questionnaire Administration and Radiation Boost in people with Anatomic Stage 0 Breast Cancer AJCC v8 and Anatomic Stage I Breast Cancer AJCC v8, run by Rutgers, The State University of New Jersey at 11 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 8 inclusion and 10 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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.
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?
Change in wound status from baseline every 3-6 months after WBI to access incidence of grade 3 or more wound complications after breast conserving surgery. (time frame: For at least 36 months after WBI). 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 22 Jan 2026.