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N/A

therapeutic conventional surgery for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is looking at whether breast-conserving surgery (removing the tumor and some surrounding tissue) followed by radiation therapy is effective in treating patients with multiple ipsilateral breast cancer.

Eligible Conditions

Breast Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

Male participants with small breasts or advanced breast cancer are unlikely to be eligible for breast-conserving surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Local Recurrence

Secondary outcome measures

Conversion Rate to Mastectomy

Patient's Perception of Cosmesis

Radiation-related Side Effects

+1 more

Side effects data

From 2016 Phase 2 trial • 378 Patients • NCT00027846

Vomiting

Leukocytes (total WBC)

Alopecia

Infection without neutropenia

Lymphopenia

Neutrophils/granulocytes (ANC/AGC)

Personality/behavioral

Seizure(s)

Infection (documented clinically or microbiologically) with grade 3 or 4 neutropenia

Neuropathy - cranial

Anorexia

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Radiation (Group 2)

Sub-Total Resection Any Histology or Location (STR) (Group 3)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Breast conservation surgery and radiation therapyExperimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

therapeutic conventional surgery

2003

Completed Phase 3

~12270

whole breast irradiation

2007

Completed Phase 3

~12990

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor

512 Previous Clinical Trials

217,364 Total Patients Enrolled

74 Trials studying Breast Cancer

39,873 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,638 Previous Clinical Trials

40,929,549 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,090 Patients Enrolled for Breast Cancer

Judy Boughey, MDStudy ChairMayo Clinic

2 Previous Clinical Trials

2,768 Total Patients Enrolled

1 Trials studying Breast Cancer

756 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being enrolled in this research project?

"No, this study is no longer recruiting patients according to the latest information available on clinicaltrials.gov. This trial was initially posted on July 1st, 2012 and had its last update on June 16th, 2022. There are, however, 2,699 other trials that are still looking for candidates."

Answered by AI

Are numerous research facilities conducting this experiment within urban areas?

"To make things more convenient for participants, this trial is being conducted at 100 sites. These locations include Seattle, Honolulu, Overland Park and many others. By selecting the site nearest to you, patients can reduce travel time and other related expenses."

Answered by AI

How often do complications arise from traditional surgery procedures?

"While Phase 2 trials offer preliminary evidence of safety, there is no data yet supporting the efficacy of therapeutic conventional surgery. Our team scored it a 2."

Answered by AI

Recent research and studies

Annals of Surgical OncologyJournal

The Feasibility of Breast-conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (alliance) Trial

Rosenkranz, Kari M., Karla Ballman, Linda McCall, Charlotte Kubicky, Laurie Cuttino, Huong Le-Petross, Kelly K. Hunt, et al.. 2018. “The Feasibility of Breast-conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (alliance) Trial”. Annals of Surgical Oncology. Springer Science and Business Media LLC. doi:10.1245/s10434-018-6583-6.

Annals of Surgical OncologyJournal

Cosmetic Outcomes Following Breast-conservation Surgery and Radiation for Multiple Ipsilateral Breast Cancer: Data from the Alliance Z11102 Study

Rosenkranz, Kari M., Karla Ballman, Linda McCall, Colleen McCarthy, Charlotte D. Kubicky, Laurie Cuttino, Kelly K. Hunt, et al.. 2020. “Cosmetic Outcomes Following Breast-conservation Surgery and Radiation for Multiple Ipsilateral Breast Cancer: Data from the Alliance Z11102 Study”. Annals of Surgical Oncology. Springer Science and Business Media LLC. doi:10.1245/s10434-020-08893-w.

International Journal of Radiation Oncology*Biology*PhysicsJournal

The Feasibility of Radiation Therapy After Breast-conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (alliance) Trial

Cuttino, Laurie W., Linda McCall, Charlotte Kubicky, Karla V. Ballman, Huong Le-Petross, Kelly K. Hunt, Bruce Haffty, Kari M. Rosenkranz, and Judy C. Boughey. 2022. “The Feasibility of Radiation Therapy After Breast-conserving Surgery for Multiple Ipsilateral Breast Cancer: An Initial Report from ACOSOG Z11102 (alliance) Trial”. International Journal of Radiation Oncology*biology*physics. Elsevier BV. doi:10.1016/j.ijrobp.2021.09.054.

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