search
Back to results

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

Primary Purpose

HER2-positive Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Omission of Radiation
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HER2-positive Breast Cancer focused on measuring omission of radiation, trastuzumab, pertuzumab, biospecimen collection, lumpectomy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center/ Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Arm A

Arm B

Arm C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Local Control Rate
Defined as biopsy positive her-2 positive tumor in the same breast

Secondary Outcome Measures

Regional Nodal Recurrence
Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
Distance Metastasis
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
Defined as death from any cause
Quality of Life
Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
Cosmetic (Breast) Outcomes
Measured using scores from patient reported outcomes using the Breast Q questionnaire
Lymphedema Rate
Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.

Full Information

First Posted
February 24, 2018
Last Updated
May 8, 2021
Sponsor
University of Kansas Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03460067
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2018 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 40 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HER2-positive Breast Cancer
Keywords
omission of radiation, trastuzumab, pertuzumab, biospecimen collection, lumpectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm B
Arm Type
No Intervention
Arm Description
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.
Arm Title
Arm C
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Omission of Radiation
Intervention Description
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
Primary Outcome Measure Information:
Title
Local Control Rate
Description
Defined as biopsy positive her-2 positive tumor in the same breast
Time Frame
up to 5 year post-op
Secondary Outcome Measure Information:
Title
Regional Nodal Recurrence
Description
Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.
Time Frame
1 month post-op, every three months post-op for 5 years
Title
Distance Metastasis
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.
Time Frame
1 month post-op, every three months post-op for 5 years
Title
Overall Survival
Description
Defined as death from any cause
Time Frame
1 month post-op, every three months post-op for 5 years
Title
Quality of Life
Description
Measured using scores from patient reported outcomes from FACT-B+4 questionnaire
Time Frame
1 month post-op, every three months post-op for 5 years
Title
Cosmetic (Breast) Outcomes
Description
Measured using scores from patient reported outcomes using the Breast Q questionnaire
Time Frame
1 month post-op, every three months post-op for 5 years
Title
Lymphedema Rate
Description
Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.
Time Frame
1 month post-op, every three months post-op for 5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shane Stecklein, MD, PhD
Phone
9135885000
Email
sstecklein@kumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Faucheux, RN
Phone
913-588-9927
Email
mfaucheux@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shane Stecklein, MD, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center/ Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66190
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Miller, BS
Phone
913-588-3670
Email
lmiller25@kumc.edu
First Name & Middle Initial & Last Name & Degree
Mindi TenNapel, PhD
Phone
913-945-9547
Email
mtennapel@kumc.edu

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs