Lumpectomy for Stage IA Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina, Chapel Hill, NC
Stage IA Breast Cancer+4 More
Lumpectomy - Procedure
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a single dose of radiation given during breast surgery may help treat breast cancer.

See full description

Eligible Conditions

  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage IIA Breast Cancer
  • Stage IIB Breast Cancer

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Lumpectomy will improve 2 primary outcomes and 4 secondary outcomes in patients with Stage IA Breast Cancer. Measurement will happen over the course of Up to 3 years after completion of radiation therapy.

Year 1
Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales
At 5 years
Rate of ipsilateral breast tumor recurrence
Year 3
Change in self-reported cosmesis using the BCTOS
Year 3
Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs
Quality of life assessed by Breast Cancer Treatment Outcome Scale
Day 30
Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (IOERT boost)
1 of 1
Experimental Treatment

This trial requires 176 total participants across 1 different treatment group

This trial involves a single treatment. Lumpectomy 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.

Treatment (IOERT boost)Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Reconstructive Surgery
2016
N/A
~70
Lumpectomy
2008
N/A
~670
Radiation Therapy
2005
Completed Phase 3
~7080

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 1 year from the end of therapy
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly at 1 year from the end of therapy for reporting.

Who is running the study

Principal Investigator
J. B.
Jose Bazan, Principal Investigator
Ohio State University Comprehensive Cancer Center

Closest Location

University of North Carolina - Chapel Hill, NC

Eligibility Criteria

This trial is for female patients 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:
Pathologically proven diagnosis of breast cancer
Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer
Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician
Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup
History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry
Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis
Absolute neutrophil count > 1800 cells/cubic mm
Platelets >= 75,000 cells/cubic mm
Hemoglobin >= 8 g/dL
Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry

Patient Q&A Section

What is breast cancer?

"If the cancer is diagnosed early enough, and is then treated properly (i.e., at its first stage), it is curable; though it is not ideal that much later, and the tumor can often be dangerous and difficult to stop once it has started." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"There are no signs that reliably diagnose [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), as is the case with many other cancers. However, some signs of breast cancer are well-known and easily visible, such as fluid-filled (fluctuant), or firm, movable breast masses. Symptoms such as redness, itchiness, or pain in the skin can be signs that there are other problems, such as a new lump in the lymph nodes, but are not signs of breast cancer alone, but in all the cases, are associated with the risk of breast cancer in the future. These symptoms need to be taken seriously if you are diagnosed with a lump in the breast or the discovery of a lump." - Anonymous Online Contributor

Unverified Answer

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

"the prevalence rate of breast cancer in Canada is about 10-10% per year, approximately one million new cases per year will develop breast cancer in Canada in 2019 to 2039 assuming present incidence rates." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"The main cause of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is exposure to hormone or DNA. There are also possible causes caused by environmental or radiation exposure. It is not clear how one causes the other. Breast enlargement and pregnancy appear to increase the risk of developing breast cancer. There is no clear evidence that breast pain, tender lymph nodes, breast lump or breast cancer risk may be increased by the use of hormones." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"There are four general categories of treatments: surgery, chemotherapy, radiation, and hormonal therapy, which may be individually chosen or combined. Most of the treatments are available to patients in the early stages of breast cancer. But in the late stages, chemotherapy or radiation may be applied, not just at the beginning of treatment but even after the surgery has been carried out. Even if it is too late for surgery, you will need the other treatments and/or medications for the remainder of your life. Thus, we need to develop effective preventive treatments." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Results from a recent clinical trial corroborate previous findings that mastectomy is unnecessary in patients with early-stage disease. Patients with ER-positive and/or PR-positive breast cancers generally do not live long enough to need a mastectomy, and their disease may be successfully managed with lumpectomy with radiation, aromatase inhibitors and trastuzumab." - Anonymous Online Contributor

Unverified Answer

Is lumpectomy typically used in combination with any other treatments?

"In comparison to breast-conserving therapies, lumpectomy is typically used (1) as a salvage therapy after surgery; (2) in patients who are younger, have larger tumors and have a shorter lifespan (< 60 years); (3) in patients who have low-risk features (triple-negative and HER-2/neu-negative); (4) with neoadjuvant chemotherapy. Nevertheless, breast-conserving therapies are also often used and only when more conservative local-regional treatments (mastectomy, lumpectomy, or other options) are preferred." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of breast cancer?

"The primary cause of breast carcinoma is unknown in most patients, but genetic factors are a major cause in about 1/3 to 1/4 of patients." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"The existence of a hereditary component of breast cancer is confirmed in the present sample but the contribution of this genetic factor in familial breast cancer may be minimal in this population." - Anonymous Online Contributor

Unverified Answer

Does lumpectomy improve quality of life for those with breast cancer?

"Lumpectomy does not improve the QoL of women with early-stage [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The improvements noted were most frequently associated with the improved likelihood of complete removal of cancer as well as improvements in cosmetic and physical aspects of the patient. Because the breast cancers were all small and the surgery time limited, the surgical outcomes were not different from that for patients undergoing BCT. Because lumpectomy is most often performed when mastectomy is indicated, these improvements in patient QoL should be expected with mastectomy as well." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for breast cancer?

"There are many factors that influence survival of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) patients. One of them is age, while gender and ethnicity have little impact on survival or prognosis. One of the things to pay attention to is the quality of cancer care delivered to patients, and the need for regular follow-up after the initiation of treatment; as well as the quality of communication between patient and oncologists/surgeons. There is a clear need to improve the quality of chemotherapy, targeted treatment and/or radiotherapy and to develop a standard treatment protocol for breast cancer." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving lumpectomy?

"No statistically significant differences were seen between the lumpectomy group and the group receiving mastectomy alone with regard to clinical outcomes (locoregional control and disease-free survival). Although these trials have been described as 'randomized,' the quality of their randomization is of concern, and a high-grade-randomized trial is required to assess their validity." - 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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