Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer (NCT01556243) | Clinical Trial Compass
CompletedPhase 2
Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer
United States270 participantsStarted 2012-07
Plain-language summary
RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
Who can participate
Age range
40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation.
. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration)
. Female Gender - Men are excluded from this study. Male breast cancer is a rare event.
. Foci of Breast Cancer
.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by \> 2 cm of normal breast tissue.
.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is Phase 2 and has already completed — does the data collected on local recurrence rates suggest that breast-conserving surgery combined with radiation is a realistic option for someone like me who has multiple tumors in the same breast, or does the evidence still favor mastectomy?
2Since having multiple tumors in the same breast has traditionally been a reason to recommend full mastectomy, can you walk me through how the outcomes from this trial might change how you'd approach my specific situation?
3The trial focused on local recurrence as its main measurement — based on what the results showed, how does the risk of the cancer coming back in the same breast compare between a lumpectomy-plus-radiation approach and a full mastectomy for my case?
4Because this was a Phase 2 study with a relatively smaller group of participants, are there any limitations in the data I should understand before deciding whether this approach is appropriate for me?
5Would my particular tumor locations, sizes, or biology make me a good or poor candidate for the breast-conserving approach this trial studied, and is there a larger or more recent trial I should also be aware of before making a decision?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.
.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI).
Exclusion criteria
. Pregnancy, Nursing and Requirement for Contraception - Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation.
. Size of Single Focus of Disease on Preoperative Imaging - Largest single focus of disease \> 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion.
. Prior Staging Procedure - Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted.
. Evidence of Metastatic Disease - Clinical or radiographic evidence of metastatic disease
. Prior History of Breast Cancer - Prior history of ipsilateral breast cancer \[DCIS, LCIS (lobular cancer in situ) or invasive\]
. Staging of Cancer - cNX, cN2, or cN3 disease
. Breast Implants - Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible.
. Systemic Illnesses or Concurrent Disease - Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma).