Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01556243|
Recruitment Status : Active, not recruiting
First Posted : March 16, 2012
Last Update Posted : April 9, 2018
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
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: therapeutic conventional surgery Radiation: whole breast irradiation||Phase 2|
- To assess the local recurrence (LR) rate with breast-conservation in patients with multiple ipsilateral primary breast cancer (MIBC).
- To examine the conversion rate to mastectomy secondary to persistent positive margins; poor cosmesis within the first year of attempting breast-conservation surgery (BCS) or inability to satisfy the radiation dose constraints on the boost to the lumpectomy bed of each site of disease.
- To assess whether patients who did not undergo re-excision for close margins (< 2 mm) have a higher local recurrence (LR) rate than patients for whom negative margins were achieved.
- To assess patient's perception of cosmesis and incidence of breast lymphedema.
- To assess incidence of breast lymphedema
- To examine the type and severity of adverse effects of breast conserving surgery and radiation for women with multiple ipsilateral primary breast cancer (MIBC).
- To examine the radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site.
OUTLINE: This is a multicenter study.
Patients undergo breast-conserving surgery (BCS) with all lesions resected to negative margins using 1 lumpectomy or 2-3 separate lumpectomy incisions at the discretion of the surgeon. Patients receive adjuvant chemotherapy and/or endocrine therapy at the discretion of the treating medical oncologist based on tumor characteristics.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)|
|Study Start Date :||July 2012|
|Estimated Primary Completion Date :||July 2020|
Experimental: Breast conservation surgery and radiation therapy
Patients undergo breast conserving surgery. Patients receive adjuvant chemotherapy at the physician's discretion. Patients receiving chemotherapy will start treatment within 12 weeks following surgery. Patients receive radiation therapy within 8 weeks following the last dose of chemotherapy or within 10 weeks following surgery if not receiving chemotherapy. Patients receive endocrine therapy at the physician's discretion. Patient observation will occur every 6 months until 5 years after the end of radiation therapy.
Procedure: therapeutic conventional surgery
Radiation: whole breast irradiation
- Local recurrence defined as histologic evidence of ductal carcinoma in situ or invasive breast cancer in the ipsilateral breast or chest wall assessed up to 5 years [ Time Frame: Up to 5 years post-treatment ]
- Conversion rate to mastectomy secondary to persistent positive margins assessed [ Time Frame: Up to 5 years post-treatment ]
- Type and severity of adverse effects of breast-conserving surgery and radiation as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [ Time Frame: Up to 30 days post-treatment ]
- Radiation-related side effects of whole-breast radiation with a boost to 1 large or > 1 lumpectomy site as assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 30 days post-treatment ]
- Patient's perception of cosmesis assessed up to 24 months after WBI using the BREAST-Q© scoring module [ Time Frame: Up to 2 years post-treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556243
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|Study Chair:||Judy Boughey, MD||Mayo Clinic|