Hypofractionated Radiation Therapy in Treating Patients With Stage 0-IIB Breast Cancer (NOVEMBER)

Utah System of Higher Education (USHE)

Status and phase

Completed

Phase 2

Conditions

Stage IB Breast Cancer

Invasive Breast Carcinoma

Stage IIB Breast Cancer

Stage IIA Breast Cancer

Stage II Breast Cancer

Stage IA Breast Cancer

Stage I Breast Cancer

Stage 0 Breast Cancer

Ductal Breast Carcinoma In Situ

Treatments

Radiation: Hypofractionated Radiation Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03345420

HCI103976 (Other Identifier)

NCI-2017-02018 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

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