Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer

NCT02515110 | Active Not Recruiting DMC

• 3 other identifiers: MCC-15-10994HM20004979NCI-2015-01317
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 2

Brief Summary

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction. Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.

Conditions

Breast Cancer; Node-positive Breast Cancer; Breast Adenocarcinoma; Invasive Breast Carcinoma; Lobular Breast Carcinoma In Situ

Keywords

lumpectomy; mastectomy without reconstruction; mastectomy with reconstruction; Estrogen Receptor Negative; Estrogen Receptor Positive; HER2/Neu Negative; HER2/Neu Positive; Progesterone Receptor Negative; Progesterone Receptor Positive; Stage IA Breast Cancer; Stage IB Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

• To evaluate the cumulative incidence of lymphedema during the 3 years following completion of hypofractionated radiation treatment

  The number of participants with incidence of lymphedema defined as ≥ 10% increase in arm circumference over baseline circumference compared to the contralateral arm measured every 6 months from the time of initiation of hypofractionated irradiation of breast and regional nodes through 3 years following the completion of radiation therapy in 2 patient cohorts: * Patients who have only had sentinel lymph node (SLN) biopsy for axillary staging * Patients who have had axillary lymph node (ALN) dissection for axillary staging

  3 years

Secondary Outcomes (3)

• Determine 5-year rate of locoregional breast cancer recurrence

  5 years

• Determine 5-year rate of distant breast cancer recurrence

  5 years

• Evaluate arm function by the frequency of patient responses indicating moderate or large differences between ipsilateral and contralateral arm function on the Patient-Reported Outcomes Questionnaire

  Baseline, then 1 month, then every 6 months through 3 years following EBRT, then yearly in years 4 and 5.

Study Arms (1)

Treatment (EBRT)

EXPERIMENTAL

External Beam Radiation Therapy (EBRT). Within 10 weeks after the last breast cancer surgery or the last dose of adjuvant chemotherapy, patients undergo hypofractionated RNI five days a week over 3-4 weeks. The three subgroups are treatment group 1- lumpectomy, treatment group 2- mastectomy, and treatment group 3- Mastectomy/ reconstruction. They are categorized depending on type of axillary surgery and treatment group. The type of axillary surgery is Sentinel lymph node (SLN) biopsy only vs axillary dissection with or without previous SLN biopsy. The treatment groups are lumpectomy vs mastectomy vs mastectomy/reconstruction.

Radiation: External Beam Radiation Therapy

Interventions

External Beam Radiation Therapy RADIATION

Breast or chest wall irradiation with hypofractionated regional nodal irradiation (RNI) will be delivered according to a hypofractionated treatment schedule of 16 fractions followed by boost of 4 to 6 fractions for patients who had a lumpectomy; a boost of 4 to 6 fractions may also be required for patients who had a mastectomy (with or without reconstruction) if the surgical margin is \< 2 mm.

Also known as: Definitive Radiation Therapy, EBRT, External Beam RT, RNI

Treatment (EBRT)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Karnofsky performance status of 70-100%
• Histologic documentation of invasive adenocarcinoma of the breast
• One of the breast disease stages listed below:
• Note: In the definitions below, definitive surgery is defined as the final surgery performed to obtain clear surgical margins
• Neoadjuvant chemotherapy was not administered \*\* If neoadjuvant chemotherapy was NOT administered, pathologic staging must be T1-3, N1-2a following definitive surgery
• Neoadjuvant chemotherapy was administered
• If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N0, pathologic staging must be T1-3, N1-2a following definitive surgery
• If prior to initiation of neoadjuvant chemotherapy clinical staging was T1-3, N1, pathologic staging must be T0-3, N0-2a following definitive surgery
• If prior to initiation of neoadjuvant chemotherapy there was cytologic or pathologic confirmation of axillary nodal involvement (per any of the criteria listed below), pathologic staging must be T0-3, N0-2a following definitive surgery
• Positive fine-needle aspiration (FNA) (ie, demonstrating malignant cells)
• Positive core needle biopsy (ie, demonstrating invasive adenocarcinoma)
• Positive sentinel lymph node biopsy (ie, demonstrating invasive adenocarcinoma)
• Complete resection of known breast disease by one of the following surgeries:
• Lumpectomy with sentinel lymph node or axillary lymph node dissection
• Mastectomy alone with sentinel lymph node or axillary lymph node dissection

You may not qualify if:

• Known definitive clinical or radiologic evidence of metastatic disease
• T4 tumors including inflammatory breast cancer
• Clinical nodal staging of N2 or N3 disease
• Pathologic nodal staging of N2b, N2c, or N3 disease
• Microscopic positive margins after definitive surgery
• \* Note: Patients with microscopically focally positive margins following lumpectomy or mastectomy are not excluded if re-excision is not technically feasible and/or there is no benefit to further surgery based on the extent and location of the positive margin
• Any history, not including the index cancer, of ipsilateral or contralateral invasive breast cancer or ipsilateral or contralateral DCIS treated with radiation therapy (RT)
• \* Note: Patients with synchronous or previous ipsilateral LCIS are eligible
• Any radiation therapy (RT) for the currently diagnosed breast cancer prior to study enrollment
• History of ipsilateral or contralateral breast or thoracic RT for any condition
• History of ipsilateral or contralateral axillary surgery for any condition
• History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
• Synchronous contralateral breast cancer requiring RT
• Overall geometry (eg, breast size if intact breast) precludes the ability to achieve dosimetric requirements
• \* Note: Set-up devices for breast positioning are permitted

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (2)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

VCU Community Memorial Healthcenter

South Hill, Virginia, 23970, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Douglas W Arthur, M.D.

  Massey Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2015
• First Posted: August 4, 2015
• Study Start: August 4, 2015
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (2)