Targeted Radiation + Drug Therapy for Breast Cancer
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Memorial Sloan Kettering Cancer Center
Disqualifiers: Pregnancy, Connective tissue disorders, others
No Placebo Group
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.
Will I have to stop taking my current medications?
No, you will not have to stop taking your current medications. Participants will stay on their usual drug therapy while receiving the targeted radiation treatment.
What data supports the effectiveness of the treatment Stereotactic Body Radiation Therapy (SBRT) for breast cancer?
Stereotactic Body Radiation Therapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR), has shown effectiveness in treating early-stage lung cancer and pulmonary metastases by delivering precise, high doses of radiation, improving tumor control and survival rates. Although direct evidence for breast cancer is limited, its success in other cancers suggests potential benefits.
12345How does the targeted radiation treatment for breast cancer differ from other treatments?
This treatment uses stereotactic ablative body radiotherapy (SABR), which delivers high doses of radiation precisely to the tumor, potentially improving outcomes by directly ablating tumors while sparing normal tissue. This approach is different from conventional radiation therapy, which typically involves lower doses over a longer period.
14567Eligibility Criteria
This trial is for adults with metastatic breast cancer who've had a good response to drug therapy for at least 6 months. It's open to those with certain hormone receptor statuses, able to consent, and have only one site of disease progression visible on a scan. Pregnant individuals, those with previous radiation at the target site or brain involvement, and serious medical conditions that conflict with radiation are excluded.Inclusion Criteria
My treatment for cancer has been working for at least 6 months without getting worse.
Consented to 12-245
My breast cancer has spread, confirmed by a biopsy.
+6 more
Exclusion Criteria
I have a serious health condition that prevents me from receiving radiation therapy.
I've had radiation before where they now want to treat, and can't have more without risking harm.
Pregnancy
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive Stereotactic Body Radiation Therapy (SBRT) to a single metastatic site while maintaining their usual drug therapy
3 months
Follow-up
Participants are monitored for progression free survival and other outcomes after SBRT
3 months
Participant Groups
The study tests adding Stereotactic Body Radiation Therapy (SBRT) targeting just one metastatic site alongside ongoing usual drug therapy in people with oligometastatic breast cancer. The goal is to see if this precise radiation can prevent the cancer from getting worse elsewhere.
1Treatment groups
Experimental Treatment
Group I: Participants with oligometastatic breast cancerExperimental Treatment1 Intervention
Participants with oligometastatic breast cancer with isolated progression after sustained (\>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking Ridge, NJ
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Uniondale, NY
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, NY
Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, NJ
More Trial Locations
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Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
References
A systematic review of outcomes following stereotactic ablative radiotherapy in the treatment of early-stage primary lung cancer. [2022]Stereotactic ablative body radiotherapy (SABR) describes a radiotherapy (RT) technique where high doses of radiation are precisely delivered to an extracranial target within the body, using either a single fraction of RT or using multiple small numbers of fractions. SABR has now become the standard of care treatment for patients with early-stage non-small-cell lung cancer (NSCLC) for whom surgery is not appropriate. This systematic review considers the evidence supporting the use of SABR in early-stage NSCLC, reported toxicity rates, the use of SABR in centrally located NSCLC, the use of SABR as salvage therapy following surgery or RT, and future potential drug combinations with SABR.
Stereotactic ablative body radiotherapy (SABR) for primary and secondary lung tumours. [2022]Stereotactic ablative body radiotherapy (SABR) represents a technological breakthrough in radiotherapy technique, with proven benefits to patients in terms of improved tumour control and overall survival. The key components of SABR are described. The current evidence base for SABR for the treatment of primary and secondary lung tumours is appraised, and key ongoing trials are identified.
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.
Stereotactic ablative radiation therapy for pulmonary metastases: Improving overall survival and identifying subgroups at high risk of local failure. [2021]Stereotactic ablative radiation therapy (SABR) is an emerging treatment option for patients with pulmonary metastases; identifying patients who would benefit from SABR can improve outcomes.
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]While conventional treatment relies on protracted courses of therapy using relatively small dose-per-fraction sizes of 1.8-2Gy, there is substantial evidence gathered over decades that this may not be the optimal approach for all targetable disease. Stereotactic ablative body radiosurgery (SABR) or stereotactic body radiation therapy (SBRT) is a technique which uses precise targeting to deliver high doses of radiation capable of ablating tumors directly. In this review, we will discuss the justification for and techniques used to deliver ablative doses to improve treatment outcomes, interactions with biological and immunologic therapy, and special procedures to spare normal tissue, which have facilitated the expanding role for these techniques in the management of a wide range of malignant histologies and disease states.
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]Stereotactic body radiation therapy (SBRT, also called stereotactic ablative body radiation SABR) is the treatment of choice for many patients with early-stage non-small cell lung cancer (NSCLC), including those who are unfit for surgery or refuse surgery.