Clinical Trials /

Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer

NCT04084730

Description:

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
  • Ductal Carcinoma In Situ
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of 3-Day Partial Breast Radiation Therapy in Women With Breast Cancer
  • Official Title: Ultra-Short External Beam-Based Accelerated Partial Breast Irradiation (APBI): A Phase II Toxicity Study Nested With a Non-inferiority Assessment of APBI in New Patient Cohorts

Clinical Trial IDs

  • ORG STUDY ID: 19-300
  • NCT ID: NCT04084730

Conditions

  • Invasive Ductal Breast Carcinoma
  • Invasive Ductal Carcinoma, Breast
  • DCIS
  • DCIS Grade 1
  • DCIS Grade 2
  • Breast Cancer

Purpose

The purpose of this study is to determine if the dose of radiation therapy that is effective in producing a treatment response, delivered over a shorter treatment period, is a safe approach that causes few or mild side effects in women with newly diagnosed breast cancer or DCIS who have had a lumpectomy procedure.

Trial Arms

NameTypeDescriptionInterventions
Participants with Breast CancerExperimentalParticipants will have unicentric pathological stage I invasive ductal breast cancer or Grade 1 or 2 DCIS measuring <3cm in longest diameter on pathology and/or mammogram that is histologically confirmed at MSKCC.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Female
    
              -  Age >/= 45 years
    
              -  Unicentric pathological stage I (pT1 or T2 pN0_M0) invasive ductal breast cancer or
                 Grade 1 or 2 (low or intermediate grade) DCIS measuring <3 cm in longest diameter on
                 pathology and/or mammogram that is histologically confirmed at MSKCC. If T2, the tumor
                 must be less than 3cm in longest diameter. Note: Women > 70 years or older with T1
                 invasive ductal carcinoma who are estrogen- receptor positive (ER+) with clinically
                 negative axillary nodes, and do not undergo surgical lymph node mapping or dissection
                 (i.e., if tumor deposit is 0.2 mm or less, regardless of whether the deposit is
                 detected by immunohistochemistry or hematoxylin and eosin staining) will also be
                 eligible
    
              -  Histologically negative tumor margin or no tumor in a re-excision specimen on final
                 shaved specimen.
    
              -  ECOG Performance Status of 0 or 1.
    
              -  Clips must be placed in the lumpectomy cavity at the time of final excision in order
                 to aid in the delineation of the tumor cavity at the time of simulation and radiation
                 delivery.
    
              -  Negative serum pregnancy test within 14 days prior to study treatment if a woman has
                 child-bearing potential. Subjects of child bearing potential are those who have not
                 been surgically sterilized or have not been free from menses for > 1 year
    
              -  Written informed consent obtained from subject and ability for subject or comply with
                 the requirements of the study
    
              -  Female subjects of childbearing potential should be willing to use 2 methods or birth
                 control or be surgically sterile or abstain from heterosexual activity for the
                 duration of study participation. Should a woman become pregnant while participating on
                 study, she should inform the treating physician immediately.
    
            Inclusion Criteria for intermediate risk substudy:
    
              -  Post-NAC cohort patients: clinical T1 or T2 (less than or equal to 5cm in longest
                 diameter on available imaging) and clinical N0 (on exam and imaging) with pathological
                 pT0 or pTis and pN0 (any regimen of neoadjuvant chemotherapy agents is allowed)
    
            OR
    
              -  Oncotype RS score of 26 or higher
    
            OR
    
              -  PAM50 ROR scored as "HIGH"
    
            OR
    
              -  Presence or LVI (focal, limited or "not otherwise specified") in the lumpectomy
                 specimen
    
            Exclusion Criteria:
    
              -  Patients with distant metastasis
    
              -  Patients who are pregnant or breastfeeding
    
              -  Patients with diffuse (>1 quadrant or >5cm) suspicious microcalcifications or patients
                 with known multicentric OR multifocal disease.
    
              -  Prior radiation therapy to the ipsilateral or contralateral breast or thorax.
    
              -  Histological evidence of extensive lymphovascular invasion (LVI)
    
              -  Histological evidence of extensive intraductal component (EIC), defined as the
                 presence of intraductal carcinoma both within the primary infiltrating ductal tumor
                 (comprising at least 25% of the tumo area) and intraductal carcinoma present clearly
                 beyond the edges of the invasive tumor, or as a predominantly intraductal tumor with
                 one or more areas of focal invasion
    
              -  Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests
                 in order to enroll on the study. Note: in the event a patient is tested and is found
                 to be a mutation carrier, she would be excluded from the study. It would be an
                 extremely rare/unlikely scenario for patients to be discovered BRCA positive after the
                 completion of PBI, as all patients with risk factors for BRCA mutations (positive
                 family history, Ashkenazi Jewish descent, ER-/PR-/her2-neu-negative receptor status)
                 are usually tested prior to radiation. Should such a situation exist, these patients
                 will be given the option of remaining on the breast conservation paradigm or opting
                 for mastectomy (as is done in this rare scenario is standard of care practice). The
                 patient will be replaced on the trial.
    
              -  History of cosmetic or reconstructive breast surgery.
    
              -  Medical condition such as uncontrolled infection (including HIV), uncontrolled
                 diabetes mellitus, or connective tissue diseases (lupus, systemic sclerosis, or other
                 collagen vascular diseases) that, in the opinion of the treating physician, would make
                 this protocol unreasonably hazardous for the patient.
    
              -  Patients with a "currently active" second malignancy other than non-melanoma skin
                 cancers. Patients are not considered to have "currently active" malignancies if they
                 have completed therapy and are considered by their physicians to be at <5% risk of
                 relapse within 3 years.
    
              -  Patients who are already enrolled in or planning to enroll in other adjuvant systemic
                 therapy protocols for both non-invasive or invasive breast cancer
    
              -  Expecting to conceive within the projected duration of the trials, starting with
                 screening visit through 180 days after the last dose of trial treatment
    
              -  Concomitant anti-neoplastic treatment is not allowed during protocol treatment and
                 should be completed at least 2 weeks prior to commencement of protocol treatment, with
                 resolution of associated acute toxicities. Bisphosponates are permitted without
                 restriction even during protocol treatment.
    
              -  Ongoing therapy with other investigational agents. Patients may not be receiving any
                 other investigational agents.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:45 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Toxicity with novel APBI schedule as determined by CTCAE version 5
    Time Frame:24 months
    Safety Issue:
    Description:The study is deemed too toxic if the rate of serious toxicity is >/= 10%.

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Memorial Sloan Kettering Cancer Center

    Trial Keywords

    • Unicentric pathological stage I breast invasive ductal breast cancer
    • Breast Cancer
    • Memorial Sloan Kettering Cancer Center
    • 19-300

    Last Updated