CLINICAL TRIAL

Hypofractionated Radiation Therapy for Carcinoma, Mammary Ductal

Waitlist Available · 18+ · All Sexes · Des Moines, IA

This study is evaluating whether a type of radiation therapy may help prevent cancer from returning in patients who have had a mastectomy.

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About the trial for Carcinoma, Mammary Ductal

Eligible Conditions
Medullary Breast Carcinoma · Breast Neoplasms · Lobular Breast Carcinoma · Carcinoma, Lobular · Stage IIB Breast Cancer · Breast Cancer, Stage II · Stage IIIA Breast Cancer · Tubular Breast Carcinoma · Carcinoma, Ductal, Breast · Stage IIA Breast Cancer · Carcinoma · Invasive Breast Carcinoma

Treatment Groups

This trial involves 2 different treatments. Hypofractionated 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 3 and have had some early promising results.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Quality-of-Life Assessment
OTHER
Laboratory Biomarker Analysis
OTHER
Questionnaire Administration
OTHER
Hypofractionated Radiation Therapy
RADIATION
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Quality-of-Life Assessment
OTHER
Laboratory Biomarker Analysis
OTHER
Questionnaire Administration
OTHER
Radiation Therapy
RADIATION

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hypofractionated Radiation Therapy
2016
Completed Phase 2
~20

Eligibility

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.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
There are no active collagen vascular diseases, such as systemic lupus erythematous, scleroderma, or dermatomyositis. show original
Patients will be staged according to the TNM staging system
No radiation therapy to the chest, neck, or axilla in the last 6 months; prior radioactive oral iodine is permitted. show original
No breast cancer in the past; no invasive breast cancer or ductal carcinoma in situ (DCIS), and no lobular carcinoma in situ (LCIS) or benign breast disease. show original
No prior or concurrent breast cancer is allowed, either invasive or non-invasive 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Up to 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 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 Hypofractionated Radiation Therapy will improve 1 primary outcome and 10 secondary outcomes in patients with Carcinoma, Mammary Ductal. Measurement will happen over the course of At to 24 months.

Physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome
AT TO 24 MONTHS
Change in Lymphedema and Breast Cancer Questionnaire and Breast Lymphedema scores at 24 months post-radiation (relative to pre-RT) and patient satisfaction scores as measured by the Breast Questionnaire overall outcome scale will be summarized and will be compared across the treatment arms using a two-sample t-test with a two-sided alternative. Linear mixed models will also be used to assess these scores longitudinally.
Patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire
AT 24 MONTHS
Was It Worth It questionnaire responses to each of the five questions at 24 months will be summarized and the will be compared across treatment arms using a chi-square tests with a two-sided alternative.
Reconstructed breast photographic cosmetic scores based on the method and timing of reconstruction received
AT 24 MONTHS
Two year photographic cosmetic scores and the proportions of patients with poor global cosmetic score will be assessed separately by timing and method of reconstruction subgroups using similar method described above.
Reconstructed breast photographic cosmetic scores
AT 24 MONTHS
Two year photographic cosmetic scores will be summarized by treatment arm and will be compared across the treatment arms using a Wilcoxon rank-sum test with a two-sided alternative. The proportions of patients with poor global cosmetic score (defined as a cosmetic score of 3: poor or large difference) at 24 months after radiation will be summarized separately by treatment arm and will be compared using a two-sample test of proportions with a two-sided alternative.
Rate of breast reconstruction complications
AT 24 MONTHS
Will be tested using a two-sample test of proportions. The test statistic will be calculated and interim analysis for futility will be performed. The primary analyses will be an intent-to-treat analysis where all patients randomized will be included in the analysis and will be analyzed based on the arm they were randomized to regardless of actual radiation schedule received. Due to the random treatment assignment with stratification for the timing of reconstruction and type of reconstruction, it is expected that the baseline patient characteristics, including the planned reconstruction procedures, are roughly balanced across the two treatment arms. A sensitivity analysis stratified by timing and type of reconstruction surgery will be conducted.
Economic analyses
UP TO 5 YEARS
Direct costs of medical care to each patient will be estimated using utilization information from the health care expense survey and the health care utilization survey, along with publicly available Medicare reimbursement rates. In particular, based on the reported number of outpatient visits to the radiation oncologist, medical oncologist, surgeon who performed mastectomy, plastic surgeon or physical therapist, and the number of visits to the emergency room, the number of hospital admissions, and the number of surgical procedures to breast reconstruction, Medicare reimbursement rates can be used to estimate what the direct cost to each patient would be if that patient were covered by Medicare. Generalized linear models will then be used to model these costs as a function of treatment, time on study, and all available baseline patient characteristics to assess the extent to which estimated direct cost is impacted by the type of radiation dosing.
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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 carcinoma, mammary ductal?

Patients with carcinoma of the breast should receive mammography, clinical examination, and breast ultrasonography regularly. They should also be counselled concerning [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) at each stage of the disease. They should be made aware that at any stage mammography will detect 85% of cancers and that breast biopsy is unnecessary. Breast self-examination in young women should be encouraged, and regular examination to exclude calcification by X-ray is essential. The use of prophylactic oophorectomy in post-menopausal women with breast cancer has been studied with contradictory results.  The majority of patients prefer the operation.

Anonymous Patient Answer

What causes carcinoma, mammary ductal?

It is possible that cancers develop from pre-cancerous lesions involving the mammary ducts. Carcinoma and carcinoma, ductal, are not completely separate entities of neoplasia of the breast. It is now believed that they may represent a single lesion with carcinoma and more recently a distinct spectrum of tumours with different disease behaviour.

Anonymous Patient Answer

How many people get carcinoma, mammary ductal a year in the United States?

About 20 million women in the United States have at least one major depressive episode each year. Women with carcinoma, mammary ductal are more than twice as likely to have a major depressive episode compared with women without carcinoma, mammary ductal.

Anonymous Patient Answer

What are common treatments for carcinoma, mammary ductal?

Most treatments for SCTs include the same procedures used in the treatment of most breast cancers. Most treatments involve surgery, chemotherapy or radiation. Very rarely a mastectomy is the indicated treatment.

Anonymous Patient Answer

Can carcinoma, mammary ductal be cured?

Recent findings, no cases of carcinoma were cured after operation. Survival of all patients was poor, because all patients had other major medical comorbidities, including cancer, and some had distant metastasis without local disease.

Anonymous Patient Answer

What is carcinoma, mammary ductal?

Carcinoma, mammary ductal is a rare type of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) that is predominantly found in postmenopausal women who have a history of breast disease. Cancers associated with carcinoma, mammary ductal include lobular carcinoma in situ, atypical ductal hyperplasia, papillary carcinoma, and juvenile ductal carcinoma. In the United States, carcinoma, mammary ductal is one of the most common forms of breast cancer among adults.

Anonymous Patient Answer

What is hypofractionated radiation therapy?

The use of hypofractionated radiation therapy delivers radiation with fewer doses but with shorter treatment times and achieves similar long-term effectiveness to more concentrated approaches. A hypofractionated approach may be appropriate for treating inoperable carcinomas of the breast because of short treatment duration and few treatment doses. This approach may reduce the risk of developing acute toxicity and treatment breaks in patients who would not tolerate protracted courses of radiation.

Anonymous Patient Answer

How serious can carcinoma, mammary ductal be?

Carcinoma, mammary ductal is, by far, most deadly malignant neoplasm. These data are in agreement with the hypothesis that the prognosis is influenced by factors independent of tumor size or spread, including gender, age, stage, and underlying systemic disease that may be associated with increased risk for future disease recurrence.

Anonymous Patient Answer

Have there been any new discoveries for treating carcinoma, mammary ductal?

The current treatments for luminal cancers are based on the assumption that they are all of the same type of tumor. We summarize the potential therapies for treating all of the luminal types.

Anonymous Patient Answer

Has hypofractionated radiation therapy proven to be more effective than a placebo?

In this small pilot study, there was no improvement in local control or loco-regional control with hypofractionated radiation compared with the placebo. Hypofractionated RT was found to be safe and tolerable. Although the study is limited by its small sample size, the results do indicate that more work is needed before a larger trial can be considered.

Anonymous Patient Answer

What is the survival rate for carcinoma, mammary ductal?

If the disease has metastasised only to the lungs then prognosis is dismal (median survival 9.3 months, 95% confidence interval 4.9-14.5). If the disease has metastasised to other sites then overall survival is 2–3 years (median 12 months, 95% confidence interval 3.4-24.7). Survival is not very good for patients who present with systemic disease (median 6.6 months, 95% confidence interval 4.9-8.5).

Anonymous Patient Answer

What is the latest research for carcinoma, mammary ductal?

The incidence and incidence rate of cancer, mammary ductal, in females has increased sharply over the last decade. This condition in women may be related to obesity and lack of physical activity.

Anonymous Patient Answer
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