Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes

NCT02700386 | Completed Phase 2 Results DMC FDA Device

• 1 other identifier: 15-1329.cc
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief Summary

The proposed study is being done to learn more about a particular dose of radiation treatment for breast cancer that is completed in a shorter amount of time than what has traditionally been used to treat breast cancer. Subjects are being asked to be in this research study because they have already had surgery for breast cancer and some cancer cells were found in their lymph nodes that drain the breast tissue.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Hypofractionated; Node-Positive Breast Cancer; Radiation Therapy; Comprehensive Radiation Therapy

Outcome Measures

Primary Outcomes (7)

• Number of Participants With at Least One Treatment-related Adverse Event of Interest

  The composite endpoint is "yes" for a given patient if that patient experienced at least one of six component adverse events: lymphedema, shoulder ROM impairment, cardiac ischemia, symptomatic rib fracture, brachial plexopathy Grade 2 ('moderate symptoms; limiting instrumental activity of daily living (ADL)') or Grade 3 ('severe symptoms; limiting self-care ADL'), or Grade 2 pneumonitis (requires steroids). AEs were assessed by CTCAE version 4.03.

  12 months and 36 months

• Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference

  An increase in interlimb arm circumference of at least 10% in the lower arm or the upper arm, or both, compared with the contralateral arm at the same timepoint, will be judged to be clinically significant lymphedema. Arm circumference 15 cm above the medial epicondyle (upper arms) and 15 cm below the medial epicondyle (lower arms) will be assessed at 12 months and at 36 months.

  12 months and 36 months

• Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT

  Symptomatic rib fracture will be diagnosed by evidence of a correlative lesion on plain film or CT.

  12 months and 36 months

• Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG

  Ischemic heart disease will be measured by the new development of angina with corresponding EKG changes, or myocardial infraction.

  12 months and 36 months

• Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23

  Shoulder stiffness severity is assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire breast cancer module (EORTC QLQ-BR23). It is assessed based on patient response to the questionnaire item, "During the past week, was it difficult to raise your arm or to move it sideways?", which is scored from 1 to 4 with 1 being "not at all" and 4 being "very much". Shoulder stiffness is identified in a patient when their response to that question is 3 or 4 AND if their response increased numerically from their response on day 1.

  12 months and 36 months

• Number of Participants With Grade 2 or Higher Pneumonitis

  Number of patients who experience pneumonitis as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.

  12 months and 36 months

• Number of Participants With Grade 2 or Higher Brachial Plexopathy

  Number of patients who experience brachial plexopathy as an adverse event at Grade 2 or higher as assessed by CTCAE v 4.03.

  12 months and 36 months

Secondary Outcomes (5)

• Number of Participants With Disease Recurrence

  Up to 60 months

• Number of Participants With Metastasis-free Survival

  12 months and 36 months

• Number of Participants With Local-regional Failure Free Survival

  12 months and 36 months

• Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30

  From baseline up to 12 months

• Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23

  Baseline to 1 year post-intervention

Study Arms (1)

Adjuvant Hypofractionated Radiation

EXPERIMENTAL

Adjuvant Hypofractionated Radiation (4005 cGy) will last 3-4 weeks with 15 treatments, +/- 4 additional fractions as a boost. Radiation should commence within 180 days of the date of primary surgery. Four additional fractions (a "boost" or "conedown") to areas deemed to be at particularly high risk of recurrence may be added at the end of the radiation course. Fraction size for the boost treatment will continue at 267 cGy for an additional 1068 cGy in four fractions.

Combination Product: Adjuvant Hypofractionated Radiation

Interventions

Adjuvant Hypofractionated Radiation COMBINATION_PRODUCT

Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.

Also known as: Radiation Therapy

Adjuvant Hypofractionated Radiation

Eligibility Criteria

• Age: 18 Years - 101 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (≥18 years old) with breast cancer who have undergone surgery for their primary breast tumor (either lumpectomy or mastectomy +/- reconstruction) and are confirmed to have involved lymph nodes on surgical pathology.
• Patient who have undergone either a total mastectomy or a lumpectomy are eligible.
• Acceptable procedures for assessment of axillary nodal status at the time of surgery include:
• axillary node dissection;
• sentinel node biopsy alone; or
• sentinel node biopsy followed by axillary node dissection.
• Eligible women include AJCC (American Joint Committee on Cancer) 7th ed. Stage cN0 or cN1 subsequently staged after surgery as Stage pIB (N1mic), pIIA, pIIB, pIIIA, pIIIB, or N3a (10 or more axillary nodes) only: note that ypN0 will also be eligible if pathologic confirmation of nodal involvement was documented prior to neoadjuvant chemotherapy and the patient was found to be node-negative at the time of surgery. Note that women less than 50 years of age, women who received chemotherapy, patients staged as pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.
• The patient must have recovered from surgery with the incision completely healed and no signs of infection. If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved. The patient must have an ECOG performance status of 0 or 1 (KPS \>70%).
• The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 180 days if chemotherapy is not delivered adjuvantly. If adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 180 days.
• Before the patient is enrolled, the consent form, including any addenda, must be signed and dated by the patient and the person who explains the study to that patient.
• Subjects will have the ability to understand, and the willingness to sign a written informed consent document.

You may not qualify if:

• patients \<18 years old
• pregnant women
• male patients
• women with T4 disease, including inflammatory breast cancer
• women who have declined or otherwise not received preceding surgery
• women with positive margins after primary surgery
• women with node-negative disease
• women without histologic confirmation of nodal involvement
• women more than 180 days out from primary breast surgery or adjuvant chemotherapy
• patients with clinically detected or suspicious lymph node involvement not readily amenable to surgical treatment (≥cN2 disease)
• patients with synchronous bilateral breast cancers
• patients with prior ipsilateral thoracic or breast radiation
• patients with distant metastatic disease (cM1) or a life expectancy of less than 5 years
• active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
• other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (3)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Memorial Hospital

Colorado Springs, Colorado, 80909, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Christine Fisher, MD, MPH
• Organization: University of Colorado, Denver

christine.fisher@cuanschutz.edu

720-848-0154

Study Officials

• Christine Fisher, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 7, 2016
• Study Start: August 11, 2016
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: April 30, 2026
• Results First Posted: April 20, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)