Testing the Usual Treatment of Radiation Therapy and HER2-Targeted Therapy to HER2-Targeted Therapy Alone for Low-Risk HER2-Positive Breast Cancer, The HERO Trial

Active:	Yes
Cancer Type:	Breast Cancer	NCT ID:	NCT05705401
Trial Phases:	Phase III	Protocol IDs:	NRG-BR008 (primary) NRG-BR008 NCI-2022-09157
Eligibility:	40 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	NRG Oncology
NCI Full Details:	http://clinicaltrials.gov/show/NCT05705401

Summary

This phase III trial compares the usual treatment of breast radiation and HER2-targeted drugs following surgery and chemotherapy to using the usual treatment approach without radiation in treating patients with low-risk HER2-positive breast cancer. The usual approach is defined as care most people get for this type of cancer. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast and continuing HER2-targeted therapy. HER2-targeted drugs attach to the HER2 receptor proteins on the surface of breast tumor cells and block the HER2 receptors from receiving growth signals in HER2-positive breast cancer. By blocking the growth signals, HER2-targeted drugs can slow or stop the growth of HER2-positive breast cancer. Radiation therapy uses high energy sources of radiation to kill tumor cells and shrink tumors. The usual approach for patients who have undergone surgery, chemotherapy, and HER2-targeted therapy and are not in a study is treatment with radiation therapy to the breast and continuing HER2-targeted therapy. Omitting radiation from the usual treatment approach may avoid the potential short-term and long-term risks of radiation in patients with low-risk HER2-positive breast cancer and may have the same effect as the usual approach in preventing cancer from coming back (recurrence ).

Objectives

PRIMARY OBJECTIVE:
I. To compare the recurrence-free interval (RFI) among patients with early-stage, low risk HER2 positive (HER2+) breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the current standard of care.

SECONDARY OBJECTIVES:
I. To estimate 7-year cumulative incidence ipsilateral breast recurrence (IBR) for radiation omitting arm and test the hypothesis that the 7-year IBR rate is <7% for patients not receiving adjuvant breast radiotherapy.
II. To estimate time to ipsilateral breast recurrence (IBR) by treatment arm.
III. To determine the time to local regional recurrence (LRR) by treatment arm.
IV. To determine disease-free survival (DFS) by treatment arm.
V. To determine overall survival (OS) by treatment arm.
VI. To evaluate whether there is a difference in patient-reported breast pain in patients who do and do not receive breast radiation in cohort A and cohort B.
VII. To evaluate whether there is a difference in patient-reported worry about recurrence in patients who do and do not receive breast radiation in cohort A and cohort B.

EXPLORATORY OBJECTIVE:
I. To explore important measures of quality of life that would reasonably be expected to vary by study arm, including cosmesis, breast-related functional status, fatigue, breast and skin symptoms, and global quality of life.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM 1: Patients receive breast radiation therapy and HER2-targeted therapy such as pertuzumab or trastuzumab subcutaneously (SC) or intravenously (IV) while on the study. Patients also undergo mammogram or magnetic resonance imaging (MRI) throughout the trial.

ARM 2: Patients receive HER2-targeted therapy such as pertuzumab or trastuzumab SC or IV while on the study. Patients also undergo mammogram or MRI throughout the trial.

Patients are followed every 6 months from randomization through year 3 and then annually from year 3 through 10.

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