Ultra Hypofractionated Whole Breast Radiation Therapy with Simultaneous Tumor Area Boost after Surgery for the Treatment of Early-Stage Breast Cancer, H-ASSIST Trial

Status: active

This phase II trial tests the safety and side effects of ultra hypofractionated whole breast radiation therapy with simultaneous tumor area boost after surgery, as well as how it works in treating women with early-stage breast cancer. Breast surgery along with radiation therapy is the standard of care for most women and helps decrease the risk of cancer coming back (recurrence). Standard treatment historically consists of radiation therapy to the entire breast for 3 to 5 weeks followed by a “boost” treatment of radiation specifically targeting the tumor area. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. 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. This trial uses a further shortened hypofractionated radiation treatment schedule (called ultra hypofractionated), along with a tumor area boost given at the same time (called simultaneous integrated boost [SIB]) over about 1 and half weeks. Giving ultra hypofractionated whole breast radiation with SIB after surgery may be safe, tolerable and/or effective in treating women with early-stage breast cancer or DCIS.

Inclusion Criteria

Willing and able to provide written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information.
Women ≥ 50 years of age with confirmed de novo invasive carcinoma of breast or ductal carcinoma in situ.
Subjects with completed breast conserving surgery (BCS) with or without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND).
Subjects planned to receive either standard of care (SOC) whole breast 3-dimensional (3D) conformal radiation therapy (3D CRT) or SOC whole breast intensity modulated radiation therapy (IMRT) with standard dose tumor bed boost.
Subjects 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, per the discretion of the treating radiation oncologist.
Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the principal investigator.

Exclusion Criteria

Receipt of concurrent breast reduction involving tissue rearrangement in the lumpectomy cavity (so that boost cannot be accurately targeted).
Synchronous bilateral breast cancer requiring bilateral radiation therapy.
Clinical or imaging evidence of distant metastases.
Prior ipsilateral breast or thoracic radiation.
Autoimmune conditions with associated radiation risks. * Collagen vascular disease (such as systemic lupus erythematosus, scleroderma, dermatomyositis, among others).
Patients with pT4 tumors.
Patients recommended to receive regional nodal irradiation.
Females of childbearing potential with a positive serum or urine pregnancy test that is obtained after the standard pre-radiation fertility discussion with their provider and before day 1 of radiation therapy. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
Are not willing to follow SOC guidelines for patients receiving radiotherapy and who may father (male) or bear (female) children.

PRIMARY OBJECTIVE:

I. To investigate the rate of moderate-marked adverse effects in the breast and chest wall for patients with early-stage breast cancer or DCIS receiving five-fraction whole breast radiation therapy with concurrent boost as measured by standard clinician assessments of radiation-specific toxicity.

SECONDARY OBJECTIVES:

I. To assess in-breast tumor recurrence (IBTR) in subjects who have received five-fraction whole breast radiation therapy with concurrent boost.

II. To assess patient-reported quality of life in subjects who have received five-fraction whole breast radiation therapy with concurrent boost.

EXPLORATORY OBJECTIVES:

I. To assess patient-reported rates of moderate-marked adverse effects in the breast and chest wall at 6 months for patients with early-stage breast cancer or DCIS receiving five-fraction whole breast radiation therapy with concurrent boost as evaluated by radiation-specific assessments of toxicity.

II. To assess patient-reported rates of moderate-marked adverse effects in the breast and chest wall at 12 months for patients with early-stage breast cancer or DCIS receiving five-fraction whole breast radiation therapy with concurrent boost as evaluated by radiation-specific assessments of toxicity.

III. To assess patient-reported rates of moderate-marked adverse effects in the breast and chest wall at 24 months for patients with early-stage breast cancer or DCIS receiving five-fraction whole breast radiation therapy with concurrent boost as evaluated by radiation-specific assessments of toxicity.

IV. To assess 2-year disease free survival (DFS) DCIS in subjects who have received five-fraction whole breast radiation therapy with concurrent boost for early-stage breast cancer or DCIS.

V. To assess 2-year overall survival (OS) in subjects who receive five-fraction whole breast radiation therapy with concurrent boost for early-stage breast cancer or DCIS.

VI. To assess patient-reported quality of life in subjects after who have received five-fraction whole breast radiation therapy with concurrent boost after 6 months.

VII. To assess patient-reported quality of life in subjects who have received five-fraction whole breast radiation therapy with concurrent boost after 24 months.

OUTLINE:

Patients undergo ultra hypofractionated whole breast irradiation (WBI) and SIB in 5 fractions every other day (QOD), excluding weekends, over about 1 and half weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) scans on study.

After completion of study treatment, patients are followed up at 6, 12, and 24 months, and then for an additional 3 years.

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Ultra Hypofractionated Whole Breast Radiation Therapy with Simultaneous Tumor Area Boost after Surgery for the Treatment of Early-Stage Breast Cancer, H-ASSIST Trial

Inclusion Criteria

Exclusion Criteria

United States

North Carolina

Chapel Hill

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Ultra Hypofractionated Whole Breast Radiation Therapy with Simultaneous Tumor Area Boost after Surgery for the Treatment of Early-Stage Breast Cancer, H-ASSIST Trial

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