Treatment for Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Sechler Family Cancer Center, Lebanon, PA
Breast Cancer+2 More
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.

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Eligible Conditions

  • Breast Cancer
  • Early Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 5 years.

5 years
Time from randomization to any death.
Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.
Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer).
Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence.
Time to invasive or noninvasive IBTR.
Year 15
Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures.

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm 2: No Breast Radiation Therapy + Endocrine Therapy
1 of 2
Arm 1: Breast Radiation Therapy + Endocrine Therapy
1 of 2
Active Control

This trial requires 1670 total participants across 2 different treatment groups

This trial involves 2 different treatments. Treatment 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.

Arm 2: No Breast Radiation Therapy + Endocrine Therapy
Drug
No radiation therapy, only hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily
Arm 1: Breast Radiation Therapy + Endocrine Therapy
Other
Radiation therapy to the breast and hormonal drug for at least 5 years. Tamoxifen 20 mg daily Anastrozole 1 mg daily Letrozole 2.5 mg daily Exemestane 25 mg daily

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 15 years.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 15 years. for reporting.

Closest Location

Sechler Family Cancer Center - Lebanon, PA

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:
The patient must be in good physical condition. show original
The patient must have had a lumpectomy and the margins of the resected specimen or re-excision must have been histologically free of invasive tumor and DCIS show original
The patient must have had axillary staging, which includes a sentinel node biopsy and/or axillary node dissection. show original
The Oncotype DX Recurrence Score is less than or equal to 18 on a diagnostic core biopsy or resected specimen. show original
AJCC The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: By pathologic evaluation, the primary tumor must be classified as pT1 (less than or equal to 2 cm). show original
Pathologic staging of pN0(i+) or pN0(mol+) patients are NOT eligible for this study. show original
Patients with a T1a tumor who do not already have an Oncotype DX Recurrence Score at study entry must send a specimen to the Genomic Health centralized laboratory. show original
The tumor is a unilateral, invasive, adenocarcinoma of the breast, as shown by histologic examination. show original
The patient or their legally authorized representative must provide consent specifying that they are aware of the study and that they agree to participate before they are allowed to join the study show original
The tumor was determined to be positive for estrogen receptors (ER) and/or progesterone receptors (PgR) according to the current American Society of Clinical Oncology/College of American Pathologists guideline recommendations show original

Patient Q&A Section

What causes breast cancer?

"Breast cancer is not one but many processes: a multi-factorial disease. The most credible theories of breast cancer genesis include (a) age-dependent accumulation of random mutation events (b) sequential acquisition of multiple lesions, and/or (c) the effects of environmental factors on genetic events." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"There is a lot of evidence that women with breast cancer are very reluctant to realize how they are suffering from the disease. Symptoms are very often not identified and not mentioned by women with breast cancer. Symptoms differ greatly between different women." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"In many countries the number of women diagnosed with breast cancer is increasing. Many of these cases are attributable to a range of factors. The most important is increasing numbers of women of reproductive age and the number of breast cancers diagnosed. There is no reason to believe that this is not a public health problem. The major public health issue is the burden of breast cancer, particularly the psychological and psychosocial issues related to it." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"In the United States in 2011 [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) was the most common form of cancer in women. More than half of breast cancer cases in women were initially treated with surgery. In contrast, the rates, of locoregional therapy and chemotherapy are significantly lower in men and women." - Anonymous Online Contributor

Unverified Answer

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

"Approximately 10 people get breast cancer in one year in the United States. It is important to inform the community about the risks of breast cancer." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Despite advances in breast cancer treatment, there is a significant number of women who experience relapse after treatment. New and potentially curative therapies are needed to prevent breast cancer relapse and to reduce the negative impact associated with treatment." - Anonymous Online Contributor

Unverified Answer

How serious can breast cancer be?

"Breast cancer is diagnosed at its earliest stages and most are non-invasive, which means that mortality is low. There is therefore no reason for alarm or intervention." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for breast cancer?

"The survival rate for breast cancer is 80%, regardless of initial diagnosis at a younger age (0 to 49 years) and stage of the disease (Stage I and II). Breast cancer, particularly women older than age 50, has undergone an improvement in the prognosis over the past 30 years." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"The familial aggregation of non-BRCA breast cancer families would be consistent with a predominant genetic aetiogenesis model. This model suggests the presence of genetic alterations at the level of the tumor cells (and their immediate progeny) with an additive and/or multiplicative role in the development of breast cancer in hereditary and some sporadic families." - Anonymous Online Contributor

Unverified Answer

Is treatment typically used in combination with any other treatments?

"Although some treatment has been shown to have a potential value in certain settings, most data indicates that when used in combination with other treatments, it is less effective than combined treatment approaches." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"The more important factor in determining spread of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) was the number of lymph nodes examined. Lymph nodes are the first places the cancer can spread because the larger the number of nodes examined, the less likely a cancer will have been found to be a sentinel node, which is not an option without an axillary radical mastectomy." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"The average age of breast cancer patients diagnosed in the United States is 62 years of age—more than 15 years later than the age at which women are generally expected to develop breast cancer. It may be time to reevaluate breast cancer screening programs." - Anonymous Online Contributor

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