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

HER2-positive Breast Cancer Clinical Trial

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 Details — Status: Terminated

Administrative data

• NCT number: NCT03460067
• Other study ID #: IIT-2017-MM-BRST-Her2noRT
• Status: Terminated
• Phase: N/A
• Start date: February 23, 2018
• Est. completion date: March 3, 2023

Study information

• Verified date: June 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: March 3, 2023
• Est. primary completion date: March 3, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center/ Cancer Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral Breast Cancer Recurrence	Defined as biopsy positive her-2 positive tumor in the same breast	up to 5 year post-op
Secondary	Regional Nodal Recurrence	Will include recurrence in the ipsilateral draining axilla, supraclavicular fossa, or internal mammary nodes.	1 month post-op, every three months post-op for 5 years
Secondary	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.	1 month post-op, every three months post-op for 5 years
Secondary	Overall Survival	Defined as death from any cause	1 month post-op, every three months post-op for 5 years
Secondary	Quality of Life using FACT-B+4	Measured using scores from patient reported outcomes from FACT-B+4 questionnaire	1 month post-op, every three months post-op for 5 years
Secondary	Cosmetic (Breast) Outcomes	Measured using scores from patient reported outcomes using the Breast Q questionnaire	1 month post-op, every three months post-op for 5 years
Secondary	Lymphedema Rate	Assessed by a diagnosis of Lymphedema in the medical record by trained lymphedema nurse.	1 month post-op, every three months post-op for 5 years