CLINICAL TRIAL

Radiation: Single Pre-Operative Radiation Therapy for Breast Cancer

Recruiting · 18+ · Female · Montreal, Canada

Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)

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About the trial for Breast Cancer

Eligible Conditions
Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Radiation: Single Pre-Operative Radiation Therapy 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Radiation: Single Pre-Operative Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
You have a positive progesterone receptor status (PR) on biopsy. show original
You have HER2 negative breast cancer. show original
Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea > 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
World Health Organization (WHO) performance status 0-2.
Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.
Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks from treatment start.
No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
You have a female aged 50 years or older.\n show original
You have a tumor less than or equal to 2 cm clinically on physical exam, and on breast ultrasound. show original
You have estrogen receptor status (ER) positive on biopsy ≥ 80%. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 0-5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 0-5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 0-5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Radiation: Single Pre-Operative Radiation Therapy will improve 1 primary outcome and 1 secondary outcome in patients with Breast Cancer. Measurement will happen over the course of 12 months.

Incidence of pathological complete response
12 MONTHS
12 MONTHS
Incidence of grade 3 or greater radiation toxicity
0-5 YEARS
0-5 YEARS

Who is running the study

Principal Investigator
M. Y.
Michael Yassa, Radiation Oncologist
Maisonneuve-Rosemont Hospital

Patient Q & A Section

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

What are the signs of breast cancer?

Breast cancer has many early signs and symptoms. Common breast symptoms include lumping in the breast or a change in nipple size or shape, nipple redness, nipple discharge and itching. These symptoms are usually of mild to moderate degree. When they are of moderate to severe degree, breast cancer should be considered, as the chances that they are breast cancer increase.

Anonymous Patient Answer

What are common treatments for breast cancer?

The choice of cancer therapy for breast cancer is largely a matter of logistics; cancer treatment depends on the aggressiveness, stage, and number of malignant masses. The primary and secondary treatment options include surgery, chemotherapy, and endocrine therapy. The choice of therapy for breast cancer should be made by a multidisciplinary team including surgeons, pathologists, oncologists, radiologists, and social workers.

Anonymous Patient Answer

What is breast cancer?

The incidence of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in Sweden is lower compared with that in other Western countries. It is highest among young women, especially among those who are most likely to be overweight. More women receive the opportunity to discuss their thoughts and feelings towards cancer with their doctors. Doctors perceive that most women are able to manage their disease effectively by themselves.

Anonymous Patient Answer

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

About 500 women get breast cancer each year, and 1,500 more had breast cancer at the time of diagnosis. Of these, about half had been diagnosed in the previous year.

Anonymous Patient Answer

What causes breast cancer?

The main causative factors of breast cancer were obesity and family history. The most common predisposing factor for breast cancer appeared to be estrogen receptor-positive, which suggests that, in developing countries, breast cancer incidence is related to the levels of estrogen and associated with hormonal imbalances.

Anonymous Patient Answer

Can breast cancer be cured?

The role of treatment and surveillance needs to be reevaluated in prospective randomised treatments, as a consequence for a better understanding of the natural history of breast cancer.

Anonymous Patient Answer

Have there been any new discoveries for treating breast cancer?

Most of the studies concerning the treatment of breast cancer are small-scale, and often have poor study design; large-scale trials of current treatments for breast cancer should be carried out. More research in this field is urgently needed.

Anonymous Patient Answer

Is radiation: single pre-operative radiation therapy typically used in combination with any other treatments?

A radiation dose of 55 Gy given for the purpose of treatment after surgery could be considered a cost-effective alternative to standard post-operative radiotherapy, particularly for stage III disease. Further prospective multicenter trials are needed to assess the potential benefits and cost effectiveness of the treatment, especially for patients with high risk disease.

Anonymous Patient Answer

What is the primary cause of breast cancer?

In the present study we found that, compared to other countries, an early age of onset of the disease was seen in India. There appeared to be a lower incidence of the disease among all the castes as compared to other European nations. Moreover, there was a higher percentage of ER-positive and triple negative tumors among the Indian women who were younger than 35 years of age when the disease was detected.

Anonymous Patient Answer

How serious can breast cancer be?

Approximately half (49%) of a population group considered by cancer specialists to qualify as very seriously ill were identified as having breast or other cancer. There remain many unknown possibilities in terms of the spectrum of disease related to breast cancer. These may include rare instances of extremely aggressive disease. Many patients do not recall if they are under the care of an oncologist and/or radiologist. We are encouraged to consider the possibility that patients may not be optimally treated by their medical care providers. It is important to remember that in this country only 5% of physicians are women and that it is doubtful whether they may be as responsive to breast cancer patients’ needs as their male counterparts.

Anonymous Patient Answer

Have there been other clinical trials involving radiation: single pre-operative radiation therapy?

In the pre-operative radiation field of the breast for breast cancer, there is a dose-response relationship between radiation dose and both side effects from the radiotherapy and recurrence rates. However, these numbers, from the reported study in 2002, are still higher than the numbers reported from the published observational studies. Clearly, there remains a need for larger studies involving pre-operative radiotherapy. Clinical trials that look at the role of pre-operative radiotherapy in non-metastatic breast cancer should report the cumulative dose, volume of tissue being irradiated, and if it is the only radiotherapy in the disease course, treatment fields and timing.

Anonymous Patient Answer

What are the latest developments in radiation: single pre-operative radiation therapy for therapeutic use?

It may be worthwhile to consider the use of a pre-operative local dose of RT for selected patients with breast cancer for whom it might be more useful to minimize surgical trauma and morbidity to prolong survival and to minimize the potential psychological effects of the treatment.

Anonymous Patient Answer
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