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

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ClinicalTrials.gov Identifier: NCT03460067
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Melissa Mitchell, University of Kansas Medical Center

Tracking Information
First Submitted Date  ICMJE February 24, 2018
First Posted Date  ICMJE March 9, 2018
Last Update Posted Date April 25, 2019
Actual Study Start Date  ICMJE February 23, 2018
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
Local Control Rate [ Time Frame: up to 5 year post-op ]
Defined as biopsy positive her-2 positive tumor in the same breast
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03460067 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
  • Regional Nodal Recurrence [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
  • Distance Metastasis [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    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.
  • Overall Survival [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Defined as death from any cause
  • Quality of Life [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
  • Cosmetic (Breast) Outcomes [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Measured using scores from patient reported outcomes using the Breast Q questionnaire
  • Lymphedema Rate [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Regional Nodal Recurrence [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
  • Distance Metastasis [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    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.
  • Overall Survival [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Defined as death from any cause
  • Quality of Life [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
  • Cosmetic (Breast) Outcomes [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Measured using scores from patient reported outcomes using the Breast Q questionnaire
  • Lymphedema Rate [ Time Frame: 1 month post-op, every three months post-op for 5 years ]
    Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.
  • Correlative Studies of Patient Samples [ Time Frame: 5 year Post-op ]
    Completed by measuring exosomes and ctDNA in patient samples collected throughout the course of treatment and follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omission of Radiation in Patients With Her-2 Positive Breast Cancer
Official Title  ICMJE Selective Use of Observation After Lumpectomy and Sentinel Lymph Node Biopsy in Her-2 Positive Patients With Pathologic Complete Response to Neoadjuvant Chemotherapy
Brief Summary 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE HER2-positive Breast Cancer
Intervention  ICMJE Radiation: Omission of Radiation
No Radiation will be given. 1 year of trastuzumab +/- pertuzumab treatment will be given with 5 years of follow up occurring every 3 months to check for recurrence
Study Arms  ICMJE
  • Experimental: Arm A
    Patient 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.
    Intervention: Radiation: Omission of Radiation
  • No Intervention: Arm B
    Patient 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.
  • No Intervention: Arm C
    Patient 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 8, 2018)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent.
  • Karnofsky Performance Status 50% to 100% (Appendix A).
  • Women 40 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Leah Miller, BS 913-588-3670 lmiller25@kumc.edu
Contact: Michelle Faucheux, RN 913-588-9927 mfaucheux@kumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03460067
Other Study ID Numbers  ICMJE IIT-2017-MM-BRST-Her2noRT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Mitchell, University of Kansas Medical Center
Study Sponsor  ICMJE Melissa Mitchell
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melissa Mitchell, MD, PhD University of Kansas Medical Center
PRS Account University of Kansas Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP