NCT01556243|CompletedPhase 2ResultsDMC

Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

Impact of Breast Conservation Surgery on Surgical Outcomes and Cosmesis in Patients With Multiple Ipsilateral Breast Cancers (MIBC)

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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3 other identifiers

ACOSOG-Z11102CDR0000728605NCI-2012-00707

Study Type

interventional

Target

270

Locations

1 country

Sites

350

Timeline

RegisteredMar 2012

StartedJul 2012

CompletionApr 2023

Brief 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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

270

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline

Completed

Started Jul 2012

Longer than P75 for phase_2 breast-cancer

Geographic Reach

1 country

350 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

10.8 years study duration

First Submitted

Initial submission to the registry

March 15, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed

4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed

9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed

11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed

8 months until next milestone

Results Posted

Study results publicly available

November 30, 2023

Completed

Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

9.9 years

First QC Date

March 15, 2012

Results QC Date

August 3, 2023

Last Update Submit

November 7, 2023

Conditions

Breast Cancer

Keywords

stage IA breast cancerstage IB breast cancerstage II breast cancerductal breast carcinoma in situlobular breast carcinoma in situ

Outcome Measures

Primary Outcomes (1)

Local Recurrence
Local recurrence(LR) 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. The estimated 5-year cumulative incidence of LR will be reported as a percentage of patients expected to experience a LR at 5 years.
5 years

Secondary Outcomes (4)

Conversion Rate to Mastectomy
5 years
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
Up to 30 days post-treatment
Radiation-related Side Effects
17 months
Patient's Perception of Cosmesis
24 months

Study Arms (1)

Breast conservation surgery and radiation therapy

EXPERIMENTAL

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 surgeryRadiation: whole breast irradiation

Interventions

therapeutic conventional surgeryPROCEDURE

Breast conservation surgery and radiation therapy

whole breast irradiationRADIATION

Breast conservation surgery and radiation therapy

Eligibility Criteria

Age40 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.
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.
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.
Foci of Breast Cancer
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.
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).
No more than 2 quadrants with biopsy proven breast cancer.
Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained.
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).
Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only.
Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy.
Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion.
Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met:
+9 more criteria

You may not qualify if:

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.
This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects.
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).
Uncontrolled Intercurrent Illness - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Bilateral Breast Cancer - Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed).
Disallowed Prior Treatments - Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed). Patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy.
Partial Breast Radiation - Planned partial breast radiation.
Known BRCA Mutations - Patients with known BRCA mutations. Patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study.
Other Active Malignancies - Other active malignancy ≤ 5 years prior to registration.
+2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (350)

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, 71913, United States

Location

Epic Care-Dublin

Dublin, California, 94568, United States

Location

Bay Area Breast Surgeons, Incorporated

Emeryville, California, 94608, United States

Location

Epic Care Partners in Cancer Care

Emeryville, California, 94608, United States

Location

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Contra Costa Regional Medical Center

Martinez, California, 94553, United States

Location

Alta Bates Summit Medical Center-Summit Campus

Oakland, California, 94609, United States

Location

Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

Naval Medical Center-San Diego

San Diego, California, 92134-3202, United States

Location

University of Colorado Cancer Center-Anschutz Cancer Pavilion

Aurora, Colorado, 80045, United States

Location

Catholic Health Initiatives NCORP

Englewood, Colorado, 80112, United States

Location

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, 06105, United States

Location

Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

Christiana Gynecologic Oncology LLC