Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer
NCT ID: NCT03345420
Last Updated: 2025-12-30
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
102 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-12-12
Study Completion Date
2025-06-26
Brief Summary
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This phase II trial studies how well hypofractionated radiation therapy works in treating patients with stage 0-IIB breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects.
Detailed Description
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Adjuvant radiation therapy (RT) plays an important role in successful breast conservation in early-stage breast cancer and has been shown to significantly reduce the risk of breast cancer recurrence over surgery alone. Adding breast radiation to lumpectomy has allowed women to keep their natural breast, as multiple randomized trials have demonstrated equivalent overall and disease-free survival compared to a mastectomy. Meta-analyses have concluded that post-lumpectomy radiation improves breast cancer survival, with an estimated 1 life saved for every 4 recurrences prevented. An important component of radiation therapy is the time-dose-fractionation schedule. Up until the last decade, the standard radiation schedule in North America involved 6-8 weeks of daily radiation.
This study proposes that fractionation will provide a significant improvement in convenience and cost effectiveness, while delivering equivalent cancer control.
This will be a phase II single arm non-inferiority trial. Trial patients will receive 9 fractions hypofractionated radiation. Patients will be evaluated for breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.
This study proposes that fractionation will provide a significant improvement in convenience and cost effectiveness, while delivering equivalent cancer control.
This will be a phase II single arm non-inferiority trial. Trial patients will receive 9 fractions hypofractionated radiation. Patients will be evaluated for breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.
Conditions
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Stage II Breast Cancer
Stage IIA Breast Cancer
Stage IIB Breast Cancer
Ductal Breast Carcinoma In Situ
Invasive Breast Carcinoma
Stage 0 Breast Cancer
Stage I Breast Cancer
Stage IA Breast Cancer
Stage IB Breast Cancer
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Treatment
Within 12 weeks after breast conserving surgery, patients undergo hypofractionated radiation therapy for 9 fractions over 2 weeks.
Group Type
EXPERIMENTAL
Hypofractionated Radiation Therapy
Intervention Type
RADIATION
Undergo hypofractionated radiation therapy
Interventions
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Hypofractionated Radiation Therapy
Undergo hypofractionated radiation therapy
Intervention Type
RADIATION
Other Intervention Names
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Hypofractionated Radiotherapy
hypofractionation
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed invasive carcinoma and/or ductal carcinoma in situ (DCIS) of the breast
* Final pathologic Tis, T1-T3, all must be N0 and M0 status.
* Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
* Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
* Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation.
* Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =\< 7 days prior to registration
* A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
* Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
* Final pathologic Tis, T1-T3, all must be N0 and M0 status.
* Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
* Radiation oncologist does not plan to treat regional lymph nodes beyond standard whole breast tangent fields
* Lumpectomy with negative lymph node on surgical evaluation (Isolated tumor cells in lymph nodes will be permitted). Patients with invasive carcinoma ≥ 70 yrs and with ER+ positive tumor ≤ 2.0cm may enroll without surgical lymph node evaluation, per section 5.1. Patients with Ductal Carcinoma In Situ (DCIS) of the breast only may enroll without surgical lymph node evaluation.
* Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =\< 7 days prior to registration
* A female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
* Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
* Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
Exclusion Criteria
* Prior radiation therapy to the chest, neck or axilla
* Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
* History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
* Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
* Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
* Co-existing medical conditions with life expectancy \< 5 years
* Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
* Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
* Neuroendocrine carcinoma or sarcoma histology
* Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
* Prior history of ipsilateral breast cancer (invasive disease or DCIS); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
* History of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
* Active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
* Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
* Co-existing medical conditions with life expectancy \< 5 years
* Other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
* Neoadjuvant chemotherapy or adjuvant chemotherapy delivered before radiation
* Neuroendocrine carcinoma or sarcoma histology
* Concurrent radiation sensitizing medications concurrent with radiation, per treatment physician
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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University of Utah
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Matthew Poppe
Role: PRINCIPAL_INVESTIGATOR
Huntsman Cancer Institute/ University of Utah
Locations
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Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States
Site Status
Countries
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United States
References
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Poppe MM, Boucher K, Gaffney DK, Brownson KE, Smith G, Howell JN, Ticona FF, Kim J, Burt L, Cannon D, Kokeny K. NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole Breast Radiation Therapy With a Simultaneous Lumpectomy Boost for Early-Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2025 Sep 1;123(1):141-149. doi: 10.1016/j.ijrobp.2025.03.078. Epub 2025 May 2.
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RESULT
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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https://pubmed.ncbi.nlm.nih.gov/40314623/
NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole Breast Radiation Therapy With a Simultaneous Lumpectomy Boost for Early-Stage Breast Cancer
Other Identifiers
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NCI-2017-02018
Identifier Type: REGISTRY
Identifier Source: secondary_id
HCI103976
Identifier Type: OTHER
Identifier Source: secondary_id
HCI103976
Identifier Type: -
Identifier Source: org_study_id