Breast CancerPhase 2NCT00909909
Radiation Therapy in Treating Women With Early Stage Breast Cancer
A Phase 2 study testing External beam boost and whole breast irradiation in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 4 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- External beam boost and whole breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesUnited States
- Study dates
- 13 May 2009to Jul 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 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer, including 1 of the following subtypes:
- Ductal carcinoma in situ
- Invasive ductal carcinoma
- Invasive lobular carcinoma
- Medullary carcinoma
- Papillary carcinoma
- Colloidal (mucinous) carcinoma
- Tubular carcinoma
- Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0)
- Tumor size ≤ 5 cm
- Breast considered technically satisfactory for radiotherapy
- Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
- Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen
- Unifocal or multifocal (confined to 1 quadrant; tumors < 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy
- No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy
- No evidence of suspicious microcalcifications in the breast before the start of radiotherapy
- If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative
- No more than 9 positive axillary lymph nodes
- No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
- No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer
- No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
- No Paget disease of the nipple
- No skin involvement, regardless of tumor size
- No distant metastases
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Pre- or post-menopausal
- ECOG performance status 0-1
- No co-existing medical condition that would limit life expectancy to < 2 years
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous)
- No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
- No psychiatric or addictive disorder that would preclude obtaining informed consent
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy for the current breast cancer
- No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy
- Chemotherapy allowed provided the following criteria are met:
- Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost)
- Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation)
- Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed
- May be initiated before, during, or after radiotherapy
- No other concurrent chemotherapy, immunotherapy, or experimental medications
Trial locations and contacts
4 sites in 1 country.
United States4 sites
RWJBarnabas Health - Robert Wood Johnson University Hospital
Hamilton, New Jersey, 08690
RWJBarnabas Health - Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08690
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
RWJBarnabas Health - Robert Wood Johnson University Hospital
Somerset, New Jersey, 08873
About this study
Official title: Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
- To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
Secondary
- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
- To identify co-variates responsible for poor cosmetic outcome in these patients.
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
- Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
- 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
- Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
- Conditions
- Breast Cancer
- Being tested
- External beam boost, whole breast irradiation
- Keywords
- ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Ductal, Breast, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External beam boostRadiation
3-dimensional conformal radiation therapy and intensity modulated radiation therapy
whole breast irradiationRadiation
accelerated, hypofractionated whole breast irradiation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI) Receives: Radiation: External beam boost; Radiation: whole breast irradiation |
| B | Active comparator | Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost Receives: Radiation: External beam boost; Radiation: whole breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
Measured: 5 years
Secondary outcomes (2)
Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0
Measured: 5 years
Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study start13 May 2009
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 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), Rutgers Cancer Institute of New Jersey
- Responsible party
- Principal investigator, Bruce G Haffty, Rutgers, The State University of New Jersey
- Investigators
- Bruce Haffty, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909909
- Sponsor's protocol ID
- Pro20170001671
- Other IDs
- CDR0000643276, P30CA072720, 0220090059, 040807
- Status last verified
- Aug 2023
- First submitted
- 28 May 2009
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Chakraborty MA, Sherwani ZK, Narra LR, Abou Yehia Z, Ohri N, Cui T, Eladoumikdachi F, Kowzun MJ, Kumar S, Potdevin L, Toppmeyer DL, Haffty BG. Preoperative Radiation Boost Results in Low Rates of Re-excision and Reduced Locoregional Treatment Time in Breast Cancer Patients. Ann Surg Oncol. 2025 Dec;32(13):9836-9842. doi: 10.1245/s10434-025-18089-9. Epub 2025 Aug 20.
PubMed 40836156Ahlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16.
PubMed 26700706
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
- ClinicalTrials.gov ID
- NCT00909909
- Acronym / sponsor ID
- Pro20170001671
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, invasive ductal breast carcinoma, invasive lobular breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, papillary ductal breast carcinoma, tubular ductal breast carcinoma, stage I breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
- Study start
- 13 May 2009 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 29 May 2009 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
- To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
Secondary
- To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
- To identify co-variates responsible for poor cosmetic outcome in these patients.
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
- Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
- 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
- Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Radiation: External beam boost, Radiation: whole breast irradiation3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI) |
| B | Active comparator | Radiation: External beam boost, Radiation: whole breast irradiationAccelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| External beam boost3-dimensional conformal radiation therapy and intensity modulated radiation therapy | Radiation | A, B |
| whole breast irradiationaccelerated, hypofractionated whole breast irradiation | Radiation | A, B |
Primary outcome
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
Time frame: 5 years
2 secondary outcomes
Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0
Time frame: 5 years
Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale
Time frame: 5 years
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 3 Aug 2023.
- Derived from this study: PubMed 40836156Chakraborty MA, Sherwani ZK, Narra LR, Abou Yehia Z, Ohri N, Cui T, Eladoumikdachi F, Kowzun MJ, Kumar S, Potdevin L, Toppmeyer DL, Haffty BG. Preoperative Radiation Boost Results in Low Rates of Re-excision and Reduced Locoregional Treatment Time in Breast Cancer Patients. Ann Surg Oncol. 2025 Dec;32(13):9836-9842. doi: 10.1245/s10434-025-18089-9. Epub 2025 Aug 20.
- Derived from this study: PubMed 26700706Ahlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16.
- 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 Haffty, MD principal investigator
Rutgers Cancer Institute of New Jersey
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing External beam boost and whole breast irradiation in people with Breast Cancer, run by Rutgers, The State University of New Jersey at 4 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?
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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 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?
Loco-regional control as assessed by physical examination, mammography, and other relevant imaging (time frame: 5 years). 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 NCT00909909, which also lists 2 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 3 Aug 2023; AzTrials last refreshed its copy on 8 Nov 2026.