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A Study of Surgery and Radiotherapy in People with Oligometastatic HER2 Positive Breast Cancer, ARCHER Trial
Trial Status: active
This phase II trial compares the effect of surgery (lumpectomy or mastectomy), locoregional radiation therapy, and stereotactic body radiation therapy (SBRT) in combination with the usual approach to the usual approach alone in treating patients with HER2 positive breast cancer that has spread from where it first started (primary site) to a small number of other parts of the body (oligometastatic). A lumpectomy is surgery to remove abnormal tissue or tumor from the breast and a small amount of normal tissue around it. It is a type of breast-sparing surgery. A mastectomy is surgery to remove the breast, or as much of the breast as possible. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Locoregional radiation therapy is radiation therapy that targets the breast, chest wall, and nearby (regional) nodes. SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. The usual approach includes hormonal therapy, targeted therapies, such as trastuzumab and pertuzumab, and/or chemotherapy. Trastuzumab and pertuzumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Hormonal therapy may lower the amount of estrogen made by the body and may block the use of estrogen by the tumor cells. This may help stop the growth of tumor cells that need estrogen to grow. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Local therapy including surgery, locoregional radiation therapy, and SBRT in combination with the usual approach may be safe, tolerable, and/or more effective compared to the usual approach alone in treating patients with oligometastatic HER2 positive breast cancer.
Inclusion Criteria
Age ≥ 18 years
Pathologically-confirmed metastatic breast cancer
Oligometastatic breast cancer (≤ 5 discrete metastatic lesions) without central nervous system (CNS) involvement; as seen on standard imaging during initial workup and monitoring prior to registration
HER2-positive breast cancer per College of American Pathologists (CAP)/American Society of Clinical Oncolgy (ASCO) guidelines as determined by staff pathologist (any estrogen or progesterone receptor status)
Based on size and location, all metastatic sites can be safely treated with either SBRT or resection
Enrolled at least 3 months (and up to 12 months) after initiation of first-line systemic therapy AND without evidence of progression as determined by treating clinician (whether clinically or radiographically) during this window. (ie. in the judgement of the treating clinician, based on standard evaluations, all known disease must be controlled prior to enrollment)
Eastern Cooperative Oncology Group (ECOG) performance status 0-2; Karnofsky performance status (KPS) 60-100
Exclusion Criteria
Any foci of disease progression during initial 3-12 months of first-line systemic therapy (as determined by treating clinician)
Escalation of systemic therapy line due to progressive disease (i.e. initiated second-line therapy prior to enrollment)
Comorbidities precluding receipt of radiotherapy, surgery or standard systemic therapy
Intracranial or intrathecal/intramedullary spinal disease (ie. CNS involvement is excluded from the study; epidural/vertebral disease is permitted)
Prior cancer history requiring chemotherapy within the past 10 years (ie. prior cancers are permitted provided no chemotherapy was administered)
Additional locations may be listed on ClinicalTrials.gov for NCT07053085.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Lior Zvi Braunstein
Phone: 201-775-7446
PRIMARY OBJECTIVE:
I. To assess if local consolidation to all sites of initial disease (locoregional breast and oligometastasis-directed therapy) improves progression-free survival (PFS) in comparison to continued systemic therapy per current standard of care.
SECONDARY OBJECTIVES:
I. To assess if local consolidation prolongs time to the next line of systemic therapy in comparison to not undergoing consolidation.
II. To assess if local consolidation prolongs overall survival (OS) in comparison to not undergoing consolidation.
III. To assess the toxicity profile of local consolidation (surgery and radiotherapy) by monitoring adverse events (per Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5).
EXPLORATORY OBJECTIVES:
I. To explore the sensitivity of circulating tumor deoxyribonucleic acid (ctDNA) detection among patients with oligometastatic HER2-positive breast cancer.
II. To explore the rate of ctDNA clearance following locoregional and metastasis-directed consolidation.
III. To characterize ctDNA kinetics during treatment and the association with subsequent disease progression and survival via prospective serial blood collection.
IV. To explore molecular factors in baseline and surgical tumor samples and their associations with disease progression, PFS and OS.
V. To assess if multiple rounds of locally-directed therapies (at discretion of the treating physicians) influence any of the above outcomes in comparison to a single instance of local consolidation.
PATIENT REPORTED OUTCOMES OBJECTIVES:
I. To describe factors that influence patients’ decisions to enroll on this study.
II. To describe illness intrusiveness prior to consolidative treatment and thereafter.
III. To describe patients’ anxiety prior to consolidative treatment and thereafter.
IV. To describe whether consolidative treatment affects patients’ quality of life.
V. To describe distress regarding cancer progression as a function of consolidative treatment.
VI. To describe participants’ expectations regarding risk the risk of progression on as a function of treatments on both arms of the study.
VII. To describe the reasons for cross-over, drop-out, or treatment discontinuation for patients who opt for alternatives to the treatment(s) assigned at randomization.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1 (CONTROL): Patients continue to receive standard of care HER2-directed systemic therapy including trastuzumab, pertuzumab, paclitaxel, or a combination of these drugs in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, computed tomography (CT), magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT throughout the study.
ARM 2 (LOCAL CONSOLIDATION): Patients undergo lumpectomy or mastectomy, external beam radiotherapy to breast/chest wall and regional nodal basins and SBRT for 1, 3, or 5 fractions to all initial sites of distant disease in the absence of disease progression or unacceptable toxicity. Patients also continue to receive standard of care HER2-directed systemic therapy including trastuzumab, pertuzumab, paclitaxel, or a combination of these drugs in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, CT, MRI and/or PET/CT throughout the study.
After completion of study intervention, patients are followed every 3 months for up to 3 years.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationMemorial Sloan Kettering Cancer Center
