Clinical Trials /

Omission of Radiation in Patients With Her-2 Positive Breast Cancer

NCT03460067

Description:

The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.

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

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Omission of Radiation in Patients With Her-2 Positive Breast Cancer
  • Official Title: Selective Use of Observation After Lumpectomy and Sentinel Lymph Node Biopsy in Her-2 Positive Patients With Pathologic Complete Response to Neoadjuvant Chemotherapy

Clinical Trial IDs

  • ORG STUDY ID: IIT-2017-MM-BRST-Her2noRT
  • NCT ID: NCT03460067

Conditions

  • HER2-positive Breast Cancer

Purpose

The primary objective of this study is to describe the rate of local control in patients with her-2 positive early stage breast cancer with a complete response to chemotherapy and lumpectomy alone.

Detailed Description

      Participants, ages 50 and older diagnosed with stage I or stage II her-2 positive, node
      negative breast cancer patients will be recommended to continue trastuzumab +/- pertuzumab
      therapy after surgery to complete a full year of therapy as standard of care under the
      clinical management of the patient's medical oncologist.

      Once neoadjuvant chemotherapy has been completed, the patient will be separated in to one of
      three arms based on a set of criteria for each. If the patient wishes to take part in the
      study, but does not have a lumpectomy with sentinel lymph node biopsy showing pCR, the
      patient will be placed in to Arm C and will proceed with radiation as standard of care. If
      the patient wishes to take part in the study, and has a lumpectomy with sentinel lymph node
      biopsy showing pCR, but does not agree to omission of radiation, the patient will be placed
      in to Arm B and will proceed with radiation as standard of care. If the patient wishes to
      take part in the study, and has a lumpectomy with sentinel lymph node biopsy showing pCR and
      agrees to omission of radiation, the patient will be placed in to Arm A with follow up
      assessments occuring at 1 month post-op, and every 3 months up to 5 years post-op.

      Data will be collected on local, regional and distant recurrence at each follow-up.The
      self-administered FACT-B+4 quality of life questionnaire will be given to patients at
      baseline, at first postoperative visit, and at the one year post-operative visit.

      Patients enrolling prior to chemotherapy will be asked to fill out the Breast-Q™ at the time
      of their first surgical consultation. Patients enrolled post-surgery will be asked to fill
      out the Breast-Q™ at their first post-operative visit. All patients will be asked to fill out
      the Breast-Q™ at their yearly postoperative visits. The Breast-Q™ is a validated patient
      assessment of breast cosmesis. This tool has both pre operative and post-operative
      components. Pre-operative Breast-Q™ questionnaire data is not required of participants in
      this study who enroll postoperatively.
    

Trial Arms

NameTypeDescriptionInterventions
Arm AExperimentalPatient is required to have lumpectomy with sentinel lymph node biopsy shows pCR and will complete 1 year of trastuzumab +/- pertuzumab treatment. No radiation, or an omission of radiation, will be given on this arm, including external beam, brachytherapy or intraoperative radiation. Patients will be required to follow up with a medical, surgical, or radiation oncologist every 3 months for 5 years. At these follow up visits, a physical exam will be performed to assess for any disease recurrence. Screening mammogram or MRI is recommended every 6 months for patients on this arm.
    Arm BNo InterventionPatient is required to have her-2 positive breast cancer, clinically node negative from exam. Patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens such as blood and urine, for correlative studies.
      Arm CNo InterventionPatient is required to have her-2 positive breast cancer, clinically node negative from exam. patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will not undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens, such as blood and urine, for correlative studies.

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Ability to understand and the willingness to sign a written informed consent.
        
                  -  Karnofsky Performance Status 50% to 100% (Appendix A).
        
                  -  Women 50 years of age or older with a diagnosis of invasive ductal carcinoma
        
                  -  Her-2 3+ or FISH ratio of 2.2 or higher, background gene expression with normal copy
                     number
        
                  -  Only postmenopausal women will be eligible. Subjects will be classified as being
                     postmenopausal if they have had:
        
                       -  No spontaneous menses > 1 year, or
        
                       -  Bilateral surgical oophorectomy, or
        
                       -  No menses for < 1 year with FSH and estradiol levels in according to
                          institutional standards
        
                  -  cT1-2N0 on clinical staging (verified to have no suspicious axillary or internal
                     mammary nodes on MRI or ultrasound)
        
                  -  Undergo neoadjuvant chemotherapy with a trastuzumab based regimen prior to surgery and
                     plan for completion of one year of trastuzumab
        
                  -  Patients are required to undergo lumpectomy with sentinel lymph node biopsy
        
                  -  Pathologic review shows no evidence of residual disease in the tumor bed (to also
                     include no evidence of residual DCIS)
        
                  -  Tumor bed should be no larger than 5 cm in size on pathologic review
        
                  -  Fibrotic area of prior tumor located at least 3 mm away from surgical margins
        
                  -  No evidence of treatment related change in the lymph nodes on pathologic review
        
                Exclusion Criteria
        
                  -  Diagnosis of inflammatory breast cancer
        
                  -  Previously diagnosed malignancy excluding basal or squamous cell carcinoma of the skin
                     (unless disease-free for 5 years or more)
        
                  -  Diagnosis of metastatic disease
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:50 Years
        Eligible Gender:Female
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Local Control Rate
        Time Frame:up to 5 year post-op
        Safety Issue:
        Description:Defined as biopsy positive her-2 positive tumor in the same breast

        Secondary Outcome Measures

        Measure:Regional Nodal Recurrence
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
        Measure:Distance Metastasis
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Defined as biopsy proven disease outside of the affected breast and draining lymphatics, or definitive radiographical evidence of distant disease, to include a positive bone scan or enhancing lesions on MRI brain.
        Measure:Overall Survival
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Defined as death from any cause
        Measure:Quality of Life
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
        Measure:Cosmetic (Breast) Outcomes
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Measured using scores from patient reported outcomes using the Breast Q questionnaire
        Measure:Lymphedema Rate
        Time Frame:1 month post-op, every three months post-op for 5 years
        Safety Issue:
        Description:Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.

        Details

        Phase:N/A
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:Melissa Mitchell

        Trial Keywords

        • omission of radiation
        • trastuzumab
        • pertuzumab
        • biospecimen collection
        • lumpectomy

        Last Updated

        April 26, 2018