CLINICAL TRIAL

APBI: 30 Gy for Breast Cancer

Metastatic
Waitlist Available · 18+ · Female · Windsor, Canada

This study is evaluating whether a higher dose of radiation might be better for women with breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
DCIS · Breast Neoplasms · Breast Cancer

Treatment Groups

This trial involves 2 different treatments. APBI: 30 Gy is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
APBI: 30 Gy
RADIATION
Experimental Group 2
APBI: 27.5 Gy
RADIATION

Eligibility

This trial is for female patients aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
If there are any positive cells in the axillary nodes, even if they are only identified with immunohistochemistry, this is considered to be negative node involvement show original
Females who have recently been diagnosed with breast cancer, regardless of whether it is ductal carcinoma in situ (DCIS) or invasive carcinoma, and who do not have evidence of metastatic disease. show original
The cancer was treated using surgery with clear margins using a microscope. 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: From date of randomization until the date of death up to 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: From date of randomization until the date of death up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From date of randomization until the date of death up to 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 APBI: 30 Gy will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 12, 24, 36 and 60 months.

Radiation toxicity assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02
12, 24, 36 AND 60 MONTHS
defined as breast induration/fibrosis, shrinkage, and telangiectasia, which will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.02.
12, 24, 36 AND 60 MONTHS
Overall survival (OS)
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF DEATH UP TO 5 YEARS
defined as the time from randomization to death from any cause.
FROM DATE OF RANDOMIZATION UNTIL THE DATE OF DEATH UP TO 5 YEARS
Cosmetic deterioration (defined as any adverse change in the global cosmetic score)
BASELINE TO TWO YEARS
defined as any adverse change in the global cosmetic score from baseline to 2 years. Subjects with global cosmetic scores that were stable or improved from baseline to 2 years will be scored as 'no deterioration'.
BASELINE TO TWO YEARS
Adverse cosmetic outcome using the EORTC Breast Cosmetic Rating System
2 YEARS POST RANDOMIZATION
The primary outcome is adverse cosmesis assessed at 2 years post randomization as determined by photographic assessment. The cosmetic outcome will be assessed by a panel of 3 trained radiation oncologists who are unaware of treatment allocation, using the EORTC Breast Cosmetic Rating System for cosmetic results for breast conserving treatment. The treated breast is compared with the untreated breast for size, shape, location of the areola/nipple, appearance of the surgical scar, presence of telangiectasia, and a global cosmetic score based on these factors. Characteristics are graded on a 4-point scale: 0 = excellent; 1 = good; 2 = fair; 3 = poor. A global cosmetic score of fair or poor will be used as the primary outcome of adverse cosmesis.
2 YEARS POST RANDOMIZATION
Disease free survival (DFS)
ONGOING THROUGHOUT STUDY UP TO 5 YEARS
defined as the time from randomization to the time of documented recurrent disease in the ipsilateral breast or regional nodes (supraclavicular, axillary or internal mammary) or distant sites (e.g. bone, liver, lung or brain).
ONGOING THROUGHOUT STUDY UP TO 5 YEARS
Ipsilateral breast tumour recurrence (IBTR)
ONGOING THROUGHOUT STUDY UP TO 5 YEARS
defined as recurrent invasive or in situ cancer in the ipsilateral breast including the axillary tail. Histological evidence of local recurrence will be required.
ONGOING THROUGHOUT STUDY UP TO 5 YEARS

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?

The signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include a lump in the breast, nipple discharge, a tingling, an abnormally firm or mobile breast, pain in the bone of the breast, and a lump in the armpit. Although these symptoms can appear without breast cancer, they are often present for other reasons and are usually not specific to the disease. If a lump persists after six months of an otherwise benign breast infection, it is cause for concern. The more worrisome signs arise after the lump has become larger and painful, and when changes are seen in part of the lymph nodes on the side of the infirm, such as a swollen, erythematous, or edematous lymph node.

Anonymous Patient Answer

What is breast cancer?

This short film illustrates the common symptoms of breast cancer, its consequences, the treatments available, the benefits of screening and the implications of screening and treatment in women of all backgrounds.

Anonymous Patient Answer

Can breast cancer be cured?

The study concluded that the data suggests there is an opportunity for eliminating breast cancer, but further research is needed before any action can be undertaken. Results from a recent clinical trial of this study are encouraging, but we need more sophisticated technology in order to implement the method.

Anonymous Patient Answer

What are common treatments for breast cancer?

The most common breast cancer treatment is surgery, which is typically used in combination with chemotherapy and/or hormone therapy. Other treatments may include tamoxifen and taxane chemotherapy. Treatment options vary by tumor subtype. Patients who have luminal A breast cancer are more likely to benefit from neoadjuvant chemotherapy as adjuvant chemotherapy should be given after lumpectomy. Patients who have triple-negative breast cancer are more likely to receive mastectomy surgery and adjuvant chemotherapy. Clinicians should consider the treatment options required for their patient and/or treatment plan.

Anonymous Patient Answer

What causes breast cancer?

Approximately 90% of all [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) cases arise from one of two mammary morphologic subtypes. The vast majority of invasive cancers have lost their expression of estrogen receptor. This loss appears to be independent of age, sex, age at menopause or radiation exposure. Although the mechanisms of progression are still unknown, the hormone hypothesis of carcinogenesis suggests the possible roles of estrogens and progesterone as key components of breast cancer pathogenesis.

Anonymous Patient Answer

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

About 100,000 women get [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the United States to each year. It is the most common cancer in women in the United States.

Anonymous Patient Answer

How quickly does breast cancer spread?

The 5-year interval from diagnosis to distant metastasis is one of the best and most useful predictors of disease progression after breast cancer treatment by mastectomy. Because distant metastasis is the most common cause of breast cancer-related death, careful follow-up should be performed.

Anonymous Patient Answer

What is the primary cause of breast cancer?

It is known that radiation plays an important role in the development of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and it is also an important cause of secondary cancers. There are many hypotheses that try to explain the relationship between the exposure to radiation and the primary causes of breast cancer, but there is not sufficient evidence to help us pinpoint the main cause of the disease.

Anonymous Patient Answer

Has apbi: 30 gy proven to be more effective than a placebo?

The data do not show improved disease free survival in this patient population after a conservative treatment scheme using a high grade, but intermediate dose BBI (30 Gy), compared to a placebo of 30 Gy.

Anonymous Patient Answer

What is the average age someone gets breast cancer?

In the United States, the current average age at diagnosis is 49.4 years, although it is higher in more developed settings. This data has been previously used to determine the age of diagnosis for [metastatic [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)](https://www.withpower.com/clinical-trials/metastatic-breast-cancer). As the cancer tends to be more aggressive as it progresses, treatment tends to be more aggressive as well, so people who get breast cancer at a young age have a higher rate of dying from the disease than when it is diagnosed at a mid-age.

Anonymous Patient Answer

Have there been other clinical trials involving apbi: 30 gy?

In a recent study, findings provides the first evidence of a reduced recurrence and survival time when radiotherapeutic techniques are performed prior to surgery in women with Stage IV breast cancer.

Anonymous Patient Answer
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