Purpose

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Criteria


- Histologically confirmed invasive carcinoma of the breast of any of the following
histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone
is not allowed

- Final American Joint Committee on Cancer (AJCC) stage IIa - IIIa (pathologic stage
T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status); pathological stage for all
patients not receiving neoadjuvant chemotherapy; higher of the clinical or
pathological T and N stage, if receiving neoadjuvant chemotherapy; patients with
pathological N0 at the time of mastectomy are only eligible if biopsy-proven
clinically N1 or N2 disease is documented prior to induction chemotherapy

- No prior radiation therapy to the chest, neck or axilla

- No prior history of ipsilateral breast cancer (invasive disease or ductal breast
carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease
is allowed

- No history of prior or concurrent contralateral invasive breast cancer; benign breast
disease, LCIS or DCIS of contralateral breast is allowed

- No active collagen vascular diseases, such as: systemic lupus erythematous,
scleroderma, or dermatomyositis

- Negative inked histologic margins from mastectomy pathology (no invasive cells at
margin)

- No significant post mastectomy complications requiring an unplanned re-operation or
admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal
completion and routine reconstruction is acceptable

- Radiation oncologist intends to treat all target volumes and respect all normal
tissues in accordance with the dosimetric constraints described (simulation before
registration recommended)

- Radiation oncologist is planning to treat regional lymph nodes including internal
mammary nodes and meet acceptable protocol dosimetric requirements

- Radiation oncologist is NOT planning to utilize a chest wall/scar boost

- Patient must have undergone immediate reconstruction at the time of mastectomy or be
planning to undergo reconstruction within 8 months after radiation

- For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days
prior to registration

- No co-existing medical conditions with life expectancy < 5 years

- No 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

- 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Group I (radiation therapy)
Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.
  • Radiation: Radiation Therapy
    Undergo RT
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
Experimental
Group II (hypofractionated radiation therapy)
Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.
  • Other: Questionnaire Administration
    Ancillary studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
  • Other: Laboratory Biomarker Analysis
    Correlative studies
  • Radiation: Hypofractionated Radiation Therapy
    Undergo hypofractionated RT

Recruiting Locations

Montefiore Medical Center-Weiler Hospital
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

Montefiore Medical Center-Einstein Campus
Bronx, New York 10461
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

Montefiore Medical Center - Moses Campus
Bronx, New York 10467
Contact:
Site Public Contact
718-379-6866
aaraiza@montefiore.org

More Details

NCT ID
NCT03414970
Status
Recruiting
Sponsor
Alliance for Clinical Trials in Oncology

Study Contact

Matthew Poppe, MD
801-581-8793
Matthew.Poppe@hci.utah.edu

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation.

SECONDARY OBJECTIVES:

I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.

II. To evaluate the local and local regional recurrence rate. III. To compare reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs] implant only) and timing of reconstruction received (immediate vs. intent for delayed).

TERTIARY OBJECTIVES:

I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.

II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received.

III. To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at 24 months after radiation.

V. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation.

VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm.

VII. To compare patient reported total health care service utilization 12 months after the completion of radiation.

VIII. To compare the economic impact of treatment. IX. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.

X. To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 to determine correlations with secondary endpoints such as local-regional control.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks.

GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks.

After completion of study, patients are followed up for 5 years.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.