Clinical trial NCT02700386: Shorter Course Radiation for the Treatment of Breast Cancer That Has Spread to Lymph Nodes
Official title: Hypofractionated, Comprehensive Radiation Therapy for Node-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast
Cancer
Hypofractionated
Node-Positive Breast Cancer
Radiation Therapy
Comprehensive Radiation Therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Subjects who join the study will receive a shortened course of radiation treatment that will last approximately four (4) weeks, instead of the traditional six (6) week course that women have typically received in this situation. The shorter course subjects will receive is designed in a way that it is thought to be equivalent to the longer course. This shorter course has already been shown to be very safe and effective when treating breast cancer in the breast tissue only. However, because cancer cells were found in the lymph nodes that drain their breast, subjects require radiation to a larger area of their chest, armpit, and shoulder than has been completely tested with this experimental dose.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. 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%).
5. 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.
6. 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.
7. Subjects will have the ability to understand, and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. patients \<18 years old
2. pregnant women
3. male patients
4. women with T4 disease, including inflammatory breast cancer
5. women who have declined or otherwise not received preceding surgery
6. women with positive margins after primary surgery
7. women with node-negative disease
8. women without histologic confirmation of nodal involvement
9. women more than 180 days out from primary breast surgery or adjuvant chemotherapy
10. patients with clinically detected or suspicious lymph node involvement not readily amenable to surgical treatment (≥cN2 disease)
11. patients with synchronous bilateral breast cancers
12. patients with prior ipsilateral thoracic or breast radiation
13. patients with distant metastatic disease (cM1) or a life expectancy of less than 5 years
14. active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
15. other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
16. patients with psychiatric or addictive disorders or other conditions that, in the opinion of the Investigator, would preclude the patient from meeting the study requirements.
17. patients with a separate non-cutaneous cancer diagnosis for which the patient has not been without evidence of disease for at least 5 years.

Note: women \<50 years of age, women who received chemotherapy, pN0 (i+ or mol+), and large-breasted women are eligible for enrollment.

Primary outcomes:
measure: Number of Participants With at Least One Treatment-related Adverse Event of Interest
timeFrame: 12 months and 36 months
measure: Number of Participants With Lymphedema Severity by Measuring Interlimb Circumference
timeFrame: 12 months and 36 months
measure: Number of Participants With Symptomatic Rib Fracture as Measured by Plain Film or CT
timeFrame: 12 months and 36 months
measure: Number of Participants With New Development of Ischemic Heart Disease as Measured by EKG
timeFrame: 12 months and 36 months
measure: Number of Participants Reporting Shoulder Stiffness as Measured by the EORTC QLQ-BR23
timeFrame: 12 months and 36 months
measure: Number of Participants With Grade 2 or Higher Pneumonitis
timeFrame: 12 months and 36 months
measure: Number of Participants With Grade 2 or Higher Brachial Plexopathy
timeFrame: 12 months and 36 months
Secondary outcomes:
measure: Number of Participants With Disease Recurrence
timeFrame: Up to 60 months
measure: Number of Participants With Metastasis-free Survival
timeFrame: 12 months and 36 months
measure: Number of Participants With Local-regional Failure Free Survival
timeFrame: 12 months and 36 months
measure: Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-C30
timeFrame: From baseline up to 12 months
measure: Number of Participants With a Change in Quality of Life Score as Measured by the EORTC QLQ-BR23
timeFrame: Baseline to 1 year post-intervention
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Colorado Springs
country: United States
facility: Memorial Hospital
state: Colorado
city: Fort Collins
country: United States
facility: Poudre Valley Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Christine Fisher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: