Standard of Care Therapy With or Without Stereotactic Radiosurgery and/or Surgery in Treating Patients With Limited Metastatic Breast Cancer

Official Title

A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiation Therapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

Summary:

This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has spread to one or two locations in the body (limited metastatic) that are previously untreated. Standard of care therapy comprising chemotherapy, hormonal therapy, biological therapy, and others may help stop the spread of tumour cells. Radiation therapy and/or surgery is usually only given with standard of care therapy to relieve pain; however, in patients with limited metastatic breast cancer, stereotactic radiosurgery, also known as stereotactic body radiation therapy, may be able to send x-rays directly to the tumour and cause less damage to normal tissue and surgery may be able to effectively remove the metastatic tumour cells. It is not yet known whether standard of care therapy is more effective with stereotactic radiosurgery and/or surgery in treating limited metastatic breast cancer.

Trial Description

Primary Outcome:

  • Progression-free survival (failure: progression or death due to any cause) (Phase II-R)
  • Overall survival (failure: death due to any cause) (Phase III)
Secondary Outcome:
  • Appearance of new metastases
  • Incidence of adverse events graded according to National Cancer Institute CTCAE version 4
  • Initial presence of CTCs in blood samples
  • Presence of CTCs after treatment in blood samples
  • Change in CTC count in blood samples
  • Levels of ctDNA in plasma samples
PRIMARY OBJECTIVES:
I. To determine whether ablation (through stereotactic body radiation therapy [SBRT] [stereotactic radiosurgery] and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. (Phase II-R) II. To determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS). (Phase III) SECONDARY OBJECTIVES:
I. To evaluate treated metastasis control according to tumour receptor status (estrogen receptor [ER], progesterone receptor [PR], human epidermal growth factor receptor [HER]-2), use of chemotherapy, surgery vs. ablative therapy, and solitary metastasis vs. 2 metastasis (may expand to >= 2 to =< 4 following completion of a Phase I trial). II. To evaluate whether the addition of ablative metastasis directed therapy significantly reduces the number of distant recurrences (new metastases) in patients who progress according to tumour receptor status (ER, PR, HER-2); use of chemotherapy, and solitary metastasis vs. 2 metastases (may expand to >= 2 to =< 4 following completion of the Phase I NRG-BR001 trial). III. To evaluate adverse events in patients who receive ablative metastasis-directed therapy to all known metastases in addition to standard medical therapy alone. IV. To explore the most appropriate and clinically relevant technological parameters to ensure quality and effectiveness throughout the radiation therapy processes, including imaging, simulation, target and critical structure definition, treatment planning, image guidance, and delivery. TERTIARY OBJECTIVES:
I. To determine whether < 5 circulating tumour cells (CTCs) (per 7.5 ml of blood) is an independent prognostic (outcome) marker for improved PFS and OS in oligometastatic breast cancer. II. To determine whether < 5 CTCs (per 7.5 ml of blood) is an independent predictive (response to therapy) marker for improved PFS and OS in oligometastatic breast cancer. III. To determine whether eliminating CTCs (0/7.5 ml of blood in patients with at least 2 CTCs at registration) is both a prognostic and predictive marker for improved PFS and OS. IV. To evaluate the prognostic and predictive properties of CTC count as a continuous measure of PFS and OS. V. To store material for retrospective analysis of circulating tumour deoxyribonucleic acid (ctDNA). VI. To store material for retrospective analysis of circulating micro-ribonucleic acid (RNA). OUTLINE:

Patients are randomized to 1 of 2 treatment arms. ARM 1: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. ARM 2: Patients continue to receive their current planned systemic therapy at the discretion of the treating physician. Patients also undergo stereotactic radiosurgery in 1, 3, or 5 fractions within 3 weeks and/or surgery at the discretion of the treating physician. ARM 1: Patients are followed every 3 months from randomization to 2 years. ARM 2: Patients are followed 25-35 days post-ablation, every 3 months from randomization to 2 years, and then yearly thereafter.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

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