Pre-Operative Radiotherapy for Breast Cancer
(SPORT-DNS Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Maisonneuve-Rosemont Hospital
Must not be taking: Hormonal therapy, Chemotherapy
Disqualifiers: BRCA mutation, Tumor > 2cm, others
Stay on your current meds
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial involves women receiving a single treatment to shrink the tumor before surgery, which will take place after some time.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does exclude participants who have had neoadjuvant hormonal manipulation or chemotherapy, which might imply some restrictions on certain treatments.
What data supports the effectiveness of the treatment Single Pre-Operative Radiation Therapy for breast cancer?
Research shows that preoperative radiation therapy can be effective in reducing the time needed for treatment and hospital stays, without increasing complications. It also suggests that using larger doses in fewer sessions may improve survival rates and reduce the chance of cancer spreading.
12345Is pre-operative radiotherapy for breast cancer safe?
Early studies suggest that pre-operative partial breast irradiation (radiation treatment) can be safely used for early-stage breast cancer, with similar local control and no increased side effects compared to traditional methods. However, long-term safety data is still being collected.
14678How is Single Pre-Operative Radiation Therapy different from other breast cancer treatments?
Single Pre-Operative Radiation Therapy is unique because it involves giving a high dose of radiation in one session before surgery, which can help shrink the tumor and potentially allow for more conservative surgery. This approach is different from the traditional method where radiation is given after surgery over several weeks.
134910Eligibility Criteria
This trial is for women aged 50 or older with early-stage breast cancer (tumors ≤2cm, ER positive ≥80%, PR positive ≥20%, Her2 negative) who are postmenopausal and have no nodal disease. It's not for those with BRCA mutations, premenopausal women, multiple tumors in one breast, prior cancers within 5 years (except certain skin cancers), or serious non-malignant diseases.Inclusion Criteria
My scans show a single area of cancer, and these were done within the last 12 weeks.
I am a woman aged 50 or older.
My tumor is 2cm or smaller, confirmed by physical exam and ultrasound.
+10 more
Exclusion Criteria
I have Paget's disease of the nipple.
You live too far away to come for check-ups and follow-up visits.
You have a breast implant or a pacemaker on the same side as the affected breast.
+21 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Radiation
Participants receive neoadjuvant single fraction radiotherapy
1 day
1 visit (in-person)
Surgery
Surgery performed after one year
1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
6 months
Participant Groups
The SPORT-DNS trial tests a single pre-operative radiation therapy followed by surgery after one year in eligible women. The aim is to see how effective this approach is compared to traditional methods where surgery occurs sooner after radiation.
1Treatment groups
Experimental Treatment
Group I: Preoperative radiotherapy for early breast cancerExperimental Treatment1 Intervention
Radiation: Single Pre-Operative Radiation Therapy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Maisonneuve-Rosemont HospitalMontreal, Canada
McGill University Health CenterMontréal, Canada
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Who Is Running the Clinical Trial?
Maisonneuve-Rosemont HospitalLead Sponsor
McGill University Health Centre/Research Institute of the McGill University Health CentreCollaborator
References
Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study - a phase I/II clinical trial protocol. [2022]Breast-conserving surgery (BCS) and whole breast radiation therapy (WBRT) are the standard of care for early-stage breast cancer (BC). Based on the observation that most local recurrences occurred near the tumor bed, accelerated partial breast irradiation (APBI), consisting of a higher dose per fraction to the tumor bed over a reduced treatment time, has been gaining ground as an attractive alternative in selected patients with low-risk BC. Although more widely delivered in postoperative setting, preoperative APBI has also been investigated in a limited, though increasing, and number of studies. The aim of this study is to test the feasibility, safety and efficacy of preoperative radiotherapy (RT) in a single fraction for selected BC patients.
[Benefits of intensive preoperative irradiation in combined therapy of breast cancer]. [2006]The therapeutic, social and economic aspects of the efficacy of intense preoperative irradiation in combined therapy of breast cancer were analysed. It has been established that preoperative irradiation in the form of the fractionation of a single focal dose of 6 Gy every other day, the summary dose of 24 Gy within 8-10 days followed by surgery 1-3 days after irradiation does not either complicate its performance or the course of the postoperative period, and by the short- and long-term results it is no worse than the routine dose fractionation. Large dose fractionation saves the time of preoperative irradiation (10 days instead of 5-6 weeks), reduces the time of inpatients' stay (56-70 days instead of 90-100 days), enables most of the patients after treatment to resume work 1.2-2 mos. earlier than after the routine dose fractionation. Preoperative irradiation in the form of large dose fractionation reduces the time of treatment, does not change its efficacy and provides for a greater economic effect.
Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? [2023]Radiation therapy represents, together with surgery and systemic treatment, the triad on which the current management of patients with breast cancer is based, achieving high control and survival rates. In recent years we have witnessed a (r)evolution in the conception of breast cancer treatment. The classic scheme of surgery followed by systemic treatment and radiotherapy is being subverted and it is becoming more and more frequent to propose the primary administration of systemic treatment before surgery, seeking to maximize its effect and favoring not only the performance of more conservative surgeries but also, in selected cases, increasing the rates of disease-free survival and overall survival. Radiotherapy is also evolving toward a change in perspective: considering preoperative primary administration of radiotherapy may be useful in selected groups. Advances in radiobiological knowledge, together with technological improvements that are constantly being incorporated into clinical practice, support the administration of increasingly reliable, precise, and effective radiotherapy, as well as its safe combination with antitumor drugs or immunotherapy in the primary preoperative context. In this paper, we present a narrative review of the usefulness of preoperative radiotherapy for breast cancer patients and the possibilities for its combination with other therapies.
Preoperative breast radiation therapy: Indications and perspectives. [2021]Preoperative breast radiation therapy (RT) is not a new concept, but older studies failed to change practice. More recently, there has been interest in revisiting preoperative RT using modern techniques. This current perspective discusses the indications, summarises the published literature and then highlights current clinical trials, with particular attention to combining with novel drugs and optimising associated translational research.
[Comparative analysis of the effectiveness of standard and large dose fractionation in preoperative breast cancer irradiation]. [2007]The report deals with a retrospective comparison of the effectiveness of standard and large-fractionated preoperative radiation therapy of breast cancer patients (each group included 85 females). As a result of distant irradiation with daily single doses of 4 Gy (total dose--20 Gy), preoperative admission period was reduced 5--7 times, as compared with standard single doses of 2 Gy and total dosage of 40--45 Gy. Large--fractionated radiation therapy results in a relatively low incidence of general and local reactions, does not interfere with surgery and is followed by postoperative complications in fewer cases. The distant metastasis frequency was significantly lower (51 +/- 5 and 32 +/- 5%, respectively), while the 5-year survival rate--higher (45 +/- 5 and 65 +/-5%, respectively) in application of large--fractionated radiation therapy. The said advantages were particularly apparent in cases of local operable tumors (stage III); in such patients, the 5-year survival rate rose from 40 +/- 7 to 64 +/- 6% (p greater than 0.05).
Pre-operative partial breast irradiation: revolutionizing radiation treatment for women with early stage breast cancer. [2023]Partial breast irradiation (PBI) has been increasingly accepted as a suitable component of breast conservation in the management of patients with early stage breast cancer, however the majority of existing studies have focused on the use of adjuvant or intra-operative techniques. Several early stage studies have more recently shown that PBI can be safely used in the pre-operative setting. Early data show similar local control without evidence of increased toxicity or worsening cosmesis, as compared to postoperative PBI or standard whole breast irradiation. While long term data are still maturing, pre-operative accelerated PBI (PAPBI) offers a number of possible clinical advantages including reducing the treatment field and increasing the number of patients eligible for PBI, identifying biomarkers of response to radiation, and improving the rates of breast conservation and treatment compliance. This review discusses key concepts and controversies surrounding PBI as it has increasingly been adopted in the US, Canada, and Europe, and introduces the concepts and early studies of PAPBI. In addition, we summarize ongoing clinical trials investigating PAPBI, review clinical benefits and challenges associated with PAPBI versus postoperative PBI, and discuss ongoing limitations as well as next generation technologies important to the implementation of PAPBI in the management of patients with early-stage localized breast cancer.
Toxicity of Hypofractionated Whole Breast Radiotherapy Without Boost and Timescale of Late Skin Responses in a Large Cohort of Early-Stage Breast Cancer Patients. [2022]To report toxicity of hypofractionated whole-breast radiotherapy in a large cohort of early-stage breast cancer (BCaients.
Stereotactic image-guided neoadjuvant ablative single-dose radiation, then lumpectomy, for early breast cancer: the SIGNAL prospective single-arm trial of single-dose radiation therapy. [2020]Adjuvant whole-breast irradiation after breast-conserving surgery, typically delivered over several weeks, is the traditional standard of care for low-risk breast cancer. More recently, hypofractionated, partial-breast irradiation has increasingly become established. Neoadjuvant single-fraction radiotherapy (rt) is an uncommon approach wherein the unresected lesion is irradiated preoperatively in a single fraction. We developed the signal (Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy) trial, a prospective single-arm trial to test our hypothesis that, for low-risk carcinoma of the breast, the preoperative single-fraction approach would be feasible and safe.
[Neoadjuvant therapy for operable breast-cancer]. [2019]Preoperative or neoadjuvant systemic treatment refers to either the first postdiagnosis systemic treatment that a patient receives or indicates that additional subsequent therapy is intended. Randomized controlled clinical trials have shown that preoperative systemic treatment offers the same disease free survival and overall survival benefits as does adjuvant systemic treatment. Neoadjuvant therapy has been found to increase the breast-conserving surgery rate. This therapy also allows to evaluate the primary tumor response to chemotherapy. Additionally, on the basis of the biologic characteristics of a tumor and differences in the response to systemic treatment, primary systemic treatment should be regarded as a tool that can be used to individualize systemic treatment for patients with breast cancer. However, some issues remain to be resolved, such as the markers that should be assessed before this therapy, as well as the optimal surgical and radiotherapy treatment.
[Evolution of radiotherapy of cancer of the breast]. [2006]A many-year-old study of 3680 breast cancer patients receiving different types of radiation therapy as part of combined or multimodality treatment led to the following conclusions. Surgical intervention used alone or the first stage of combined treatment was found appropriate for stage I only. The most preferable modality in all cases was preoperative irradiation provided in large fractional regimens for operable tumors and, when possible, in combination with UHF-therapy; the use of common fractions with the incorporation of a primary focus and all zones of regional metastatic spreading in the zone of radiation exposure was found appropriate for inoperable tumors.