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Testing Radiation and HER2-targeted Therapy Versus HER2-targeted Therapy Alone for Low-risk HER2-positive Breast Cancer (HERO)

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ClinicalTrials.gov Identifier: NCT05705401
Recruitment Status : Recruiting
First Posted : January 30, 2023
Last Update Posted : September 5, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Eastern Cooperative Oncology Group
SWOG Cancer Research Network
Information provided by (Responsible Party):
NRG Oncology

Study Description
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Brief Summary:
This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk 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 standard of care.

Condition or disease Intervention/treatment Phase
HER2-positive Breast Cancer Radiation: Standard of Care Adjuvant Breast Radiation Drug: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects who are receiving standard of care systemic HER2-targeted therapies are randomized to standard of care adjuvant breast radiation or no breast radiation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Randomized Trial of Radiotherapy Optimization for Low-Risk HER2-Positive Breast Cancer (HERO)
Actual Study Start Date : March 13, 2023
Estimated Primary Completion Date : February 1, 2034
Estimated Study Completion Date : February 1, 2037

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard of Care Adjuvant Breast Radiation
Patients continue to receive their current planned adjuvant breast radiation and systemic HER2-targeted therapies
 Radiation: Standard of Care Adjuvant Breast Radiation
adjuvant breast radiotherapy per the current standard of care
Active Comparator: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
Patients continue to receive their current systemic HER2-targeted therapy without breast adjuvant radiation
 Drug: Standard of Care HER2-targeted Therapy Without Adjuvant Breast Radiation
participants are randomized to continue their standard of care systemic HER2-targeted therapy without adjuvant breast radiotherapy


Outcome Measures
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Primary Outcome Measures :
  1. recurrence-free interval (RFI) [ Time Frame: From randomization to first recurrence event or censoring for the duration of the trial, at 10.5 years ]
    Time to recurrence event or censoring


Secondary Outcome Measures :
  1. ipsilateral breast recurrence (IBR) for radiation omitting arm [ Time Frame: From randomization to first recurrence event or censoring for the duration of the trial , measured at year 7 ]
    Time to IBTR event or censoring

  2. ipsilateral breast recurrence (IBR) by treatment arm [ Time Frame: From randomization to first recurrence event or censoring for the duration of the trial at 10.5 years. ]
    Time to ipsilateral breast recurrence (IBR) by treatment arm.

  3. local regional recurrence (LRR) by treatment arm [ Time Frame: From randomization to first recurrence event or censoring for the duration of the trial at 10.5 years. ]
    Time to local regional recurrence (LRR) by treatment arm.

  4. disease-free survival (DFS) by treatment arm. [ Time Frame: From the time of randomization for the duration of the trial at 10.5 years. ]
    To determine disease-free survival (DFS) by treatment arm.

  5. overall survival (OS) by treatment arm. [ Time Frame: From the time of randomization for the duration of the trial at 10.5 years. ]
    To determine overall survival (OS) by treatment arm.

  6. patient-reported breast pain by treatment arm using the Breast Cancer Treatment Outcome Scale (BCTOS) [ Time Frame: At 3 years after randomization ]
    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. The BCTOS pain score has a range from 1-5 with higher scores indicating worse pain.

  7. patient-reported worry about recurrence by treatment arm using a the three-item worry about recurrence score [ Time Frame: At 3 years after randomization ]
    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. The worry about recurrence score has a range from 1-5 with higher scores indicating more worry.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.

  • female and male patients who have undergone breast conserving surgery and completed a minimum of 4 cycles (12 weeks) of neoadjuvant or adjuvant chemotherapy in combination with HER2-targeted therapy.

    -≥ 40 years of age

  • ECOG performance status of 0 ,1, or 2/Karnofsky performance status above 60
  • Histologically or cytologically confirmed invasive breast carcinoma.
  • tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
  • Patient must have undergone axillary staging, either sentinel node biopsy (SNB) or axillary lymph nodal dissection (ALND). In neoadjuvant patients, SNB following neoadjuvant therapy is strongly recommended. SNB prior to neoadjuvant therapy is discouraged, but patients are permitted if node negative (pN0).
  • The following staging criteria must be met according to AJCC 8th edition criteria:

Adjuvant cohort : By pathologic evaluation, the patient's primary tumor must be </= 2 cm and ipsilateral nodes must be pN0. Surgical lumpectomy margins must be negative for invasive cancer and ductal carcinoma in situ (no ink on tumor).

Neoadjuvant cohort: Prior to neoadjuvant therapy, the patient's primary tumor must be < 3 cm by imaging studies, with negative axillary nodes (cN0) based on axillary U/S, CT, PET or MRI. Physical examination is not sufficient documentation of cN0 status; • Must be ypT0N0 at surgery (lumpectomy); patients with residual non-invasive disease (DCIS) in the surgical specimen (ypTis), are NOT eligible.

  • For the Adjuvant cohort, adjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.
  • For the Neoadjuvant cohort, neoadjuvant therapy must have consisted of a minimum of 4 cycles (12 weeks) of chemotherapy in combination with HER2-targeted therapy.- ; Patients who did not receive chemotherapy in the neoadjuvant setting are not eligible, even if they achieved pCR with their preoperative treatment; nor would these patients become eligible by receiving chemotherapy after surgery.
  • In patients assigned to radiation therapy, treatment should start ≤ 12 weeks from surgery on the Neoadjuvant cohort and ≤ 8 weeks from the completion of chemotherapy on the Adjuvant cohort. Patients should continue HER2-targeted therapy during assigned study treatment (radiation or observation).
  • Bilateral mammogram or MRI within 52 weeks prior to randomization.
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.

Exclusion Criteria:

  • Definitive clinical or radiologic evidence of metastatic disease.
  • On the Adjuvant cohort, patients with a primary tumor >2 cm on pathologic examination of the surgical specimen. On the Neoadjuvant cohort, patients with a primary tumor > 3 cm or with abnormal or suspicious ipsilateral axillary nodes by pretreatment imaging, unless demonstrated to be negative by cytologic or histologic examination.
  • Pathologically positive axillary nodes at any time including of pN0(i+) or pN0(mol+) ypN0(i+) or ypN0(mol+) disease.
  • Patient planning for or status-post mastectomy.
  • Radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary lymph nodes, unless there is histological confirmation that these nodes are negative for metastatic disease.
  • Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast), or mass or non-mass enhancement on MRI (if performed) aside from the known cancer, unless biopsied and found to be benign.
  • Non-epithelial breast malignancies such as sarcoma or lymphoma.
  • Multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by > 4 centimeters. If multifocal, all foci should be confined to a maximum tumor bed of 3 cm determined by pathological assessment.
  • Paget's disease of the nipple.
  • Synchronous (unilateral or bilateral) invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.)
  • On the Adjuvant cohort, surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible).
  • Treatment plan that includes regional nodal irradiation.
  • Patients treated for a prior invasive breast malignancy are excluded. Contralateral DCIS ≥ 10 years prior to enrollment is permissible.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible unless discontinued prior to randomization.
  • Prior ipsilateral breast or thoracic RT for any condition (contralateral RT for DCIS ≥ 10 years prior to randomization is permitted).
  • Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active systemic lupus erythematosus, or scleroderma.
  • Clinicians should consider whether any conditions would make this protocol unreasonably hazardous for the patient.
  • Pregnancy or lactation at the time of randomization or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for patients of childbearing potential must be performed within 14 days prior to randomization.)
  • Use of any investigational product within 30 days prior to randomization.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05705401


Contacts
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Contact: Director, Department of Regulatory Affairs 412-339-5300 langerj@nrgoncology.org
Contact: Norman Wolmark, MD

Locations
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Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Eastern Cooperative Oncology Group
SWOG Cancer Research Network
Investigators
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Principal Investigator: Norman Wolmark, MD NRG Oncology
More Information
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Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT05705401    
Other Study ID Numbers: NRG-BR008
5U10CA180868 ( U.S. NIH Grant/Contract )
NCI-2022-09157 ( Other Identifier: NCI )
First Posted: January 30, 2023    Key Record Dates
Last Update Posted: September 5, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases