Sterotactic Body Radiotherapy/SBRT for Breast Cancer

1
Effectiveness
2
Safety
Memorial Sloan Kettering Rockville Centre, Rockville Centre, NY
Breast Cancer+8 More
Sterotactic Body Radiotherapy/SBRT - Radiation
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a type of radiation therapy may help slow the growth of tumors.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Lung Cancer
  • Triple Negative Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Lung Neoplasms
  • Stage IV, NSCLC
  • Non Small Cell Lung Cancer Metastatic
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • NSCLC Stage IV Without EGFR/ALK Mutation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Sterotactic Body Radiotherapy/SBRT will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of Up to 52 weeks after final participant is enrolled.

Month 100
Overall survival
Week 52
Progression Free Survival

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Arm 2:Standard of Care
Arm 1: Early Stereotactic Body Radiotherapy/SBRT

This trial requires 107 total participants across 2 different treatment groups

This trial involves 2 different treatments. Sterotactic Body Radiotherapy/SBRT is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Arm 1: Early Stereotactic Body Radiotherapy/SBRT
Radiation
SBRT to all oligoprogressive sites
Arm 2:Standard of Care
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months for reporting.

Closest Location

Memorial Sloan Kettering Rockville Centre - Rockville Centre, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 or older
Willing and able to provide informed consent
Triple negative breast cancer TNBC (ER <1%, PR <1%, her-2-neu 0- 1+ by IHC or FISH-negative or as determined by MD discretion)
OR NSCLC (without known EGFR mutation or ALK/ROS1 rearrangement)
OR Other high-risk breast cancer (per physician's discretion) progressed on hormone or systemic therapy, regardless of ER/HER2 status
OR NSCLC with EGFR, ALK, or ROS1 targetable molecular alterations with disease progression on first-line tyrosine kinase inhibitor Biopsy of metastasis prior to enrollment is per treating physician's discretion per standard of care. It is preferred but not required.
These patients are selected for the study given the similar survival outcomes when given standard of care therapies
Patient has received at least first-line prior treatment with systemic therapy (either cytotoxic or targeted, including maintenance therapies).
Patients who received prior immunotherapy are allowed.
Patients who had any prior radiation therapy near or overlapping with the oligoprogressive sites are allowed to enroll.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can breast cancer be cured?

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Despite research demonstrating the effectiveness of both chemotherapy and surgery, there are large number of breast cancer patients who are still in remission following surgery.

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What are the signs of breast cancer?

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Results from a recent clinical trial, no significant association was found between breast symptoms, demographic factors, or other co-morbidities and breast cancer screening behaviour or screening uptake.

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What causes breast cancer?

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We have been unable to identify any strong link between breast cancer and any of the major factors known to increase the risk of breast cancer: smoking, alcohol use, diet, exercise, obesity, or hormone replacement therapy. More research is needed to better understand the complexities of breast cancer and its causes.

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What is breast cancer?

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Breast cancer usually occurs as either a malignant lump or as a lumpy mass in the breast that is painless. This article focuses on lump mammography--which is the use of mammography to detect breast cancer or to evaluate suspicious areas in the breasts. Once it is found, a biopsy is performed to confirm that it is cancer. The cancer is treated either with surgery for removal of the lump or whole breast, or with tamoxifen for the treatment of estrogen receptor-positive, node-negative breasts. The treatment of choice for node-negative disease is a combination of tamoxifen and/or aromatase inhibitor therapy.

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What are common treatments for breast cancer?

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Common treatments for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) are surgery, medications, hormonal therapy, radiotherapy, and clinical trials. Surgery is the most common treatment strategy for breast cancer, followed by breast-conserving surgery (BCS) with radiotherapy, and BCS with hormonal therapy. Patients are more likely to be offered chemotherapy after they have been informed and consent for BCS, and postoperative radiotherapy is more common with mastectomy.

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How many people get breast cancer a year in the United States?

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The incidence rate of breast cancer in the US, which has been stable over the past two decades, is likely reflective of the increasing incidence of breast cancer in the United States, because of the large increase in both use of the mammogram procedure and the number of women who are screened.

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What is the survival rate for breast cancer?

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More women with metastatic disease would live longer if they were treated with new and better targeted treatments with hormonal therapy as compared with conventional cytotoxic chemotherapy and are treated with hormonal therapy. The survival rate for breast cancer appears to have improved at least for the women who have a good response to hormone therapy.

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Have there been any new discoveries for treating breast cancer?

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In 2008 and 2009, two new drugs were approved by the FDA. They provided better and longer answers to [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and gave doctors less time to explore other possibilities. The new drugs were Herceptin (2008) and Erbitux (2009). For the past 11 years, however, there hadn't been any drugs approved to kill the cancer cells that have spread to the lining of the breast. There was no one to target the mutated genes that cause a cancer cell to grow into a solid tumor, and so there was no way to cut off the mutated genes in the body, and destroy the cancer cells that spread to other areas of the body.

Unverified Answer

Have there been other clinical trials involving sterotactic body radiotherapy/sbrt?

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A review of our recent published studies (except for this present study) does not provide further information on sbrt. The first published, which was a retrospective review (a study where subjects do not receive treatment according to a certain treatment protocol) of 18 patients with stage I-IIIB breast carcinoma treated with sbrt (12 patients, dose 50 Gy) showed the following conclusions: • This retrospective study shows significant, favorable, long-term outcomes including excellent overall survival and DMF rates after sbrt.

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Who should consider clinical trials for breast cancer?

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These clinicians will not necessarily advise their patients not to participate in clinical trials. The patients should discuss clinical trials with their health care provider, decide whether the potential benefits of clinical trials exceed the potential risks, and take an informed decision.

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What are the common side effects of sterotactic body radiotherapy/sbrt?

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All patients should be cautioned of potential physical and psychological toxicity of SBRT, particularly for treating early breast cancer, and with increasing numbers treated with this modality, we should carefully monitor early onset acne, osteopenia (a decline in bone density), and cognitive dysfunction, especially when dosimetry of the irradiated target is close to or below the threshold for subclinical bone damage and for the risk of peripheral paresthesias. We should also closely monitor patients for the development of lymphedema and/or skin changes, especially if the irradiated volume is large and/or if dose delivery is incomplete.

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What is the latest research for breast cancer?

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The research for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) should be reviewed for current evidence as it will aid in identifying effective and safe treatments in a timely manner which will also improve patient outcomes. The data review process needs to be implemented by the National Cancer Control Programs so that more research is conducted in an evidence-based framework.

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